A Continuation Protocol for Deucravacitinib in Adult Patients With Systemic Lupus Erythematosus (SLE) or Sjögren's Disease (SjD) and Pediatric Patients With Psoriasis (PsO) or Psoriatic Arthritis (PsA) Who Have Completed Parent Studies

This study is designed to provide treatment with deucravacitinib for participants with SLE/SjD (Systemic Lupus Erythematosus/Sjögren's Disease) and pediatric participants with PsO/PsA (Psoriasis/Psoriatic Arthritis) who have completed their qualified parent studies and/or long-term extension if applicable.

Start Date31 Dec 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT07352566

/ Not yet recruitingPhase 4IIT

Utilization of a Cutaneous Therapy In Situ Microdevice

This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.
The small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.

Start Date01 Aug 2026

Sponsor / Collaborator

The University of California, San Francisco

CTRI/2026/07/113325

/ Not yet recruitingNot Applicable

An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Deucravacitinib 6 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India with SOTYKTU Deucravacitinib 6 mg tablet Distributed by Bristol-Myers Squibb Company Princeton New Jersey 08543 USA in healthy adult human trial participants under fed conditions - NIL

Start Date15 Jul 2026

Sponsor / Collaborator

BDR Pharmaceuticals International Pvt Ltd.

100 Clinical Results associated with Deucravacitinib

100 Translational Medicine associated with Deucravacitinib

100 Patents (Medical) associated with Deucravacitinib

367

Literatures (Medical) associated with Deucravacitinib

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Real-world outcomes of deucravacitinib in Chinese plaque psoriasis patients: a 24-week prospective study

Article

Author: Zhang, Zhiwei ; Zhou, Jing ; Wu, Zhouwei ; Tan, Xi

Aim: Deucravacitinib, a selective tyrosine kinase 2 (TYK2) inhibitor, has demonstrated efficacy in randomized trials for plaque psoriasis, but real-world data in Asian populations remain limited. This 24-week prospective real-world cohort study evaluated the effectiveness and safety of deucravacitinib in 101 Chinese adults with plaque psoriasis treated with 6 mg once daily.Materials and methods: The prespecified primary endpoint was PASI75 at week 24. Secondary outcomes included PASI90, PASI100, PASI ≤1, and sPGA 0/1 at week 24.Results: At baseline, 68.3% of patients had PASI <10. At week 24, 77.2% achieved PASI75, 58.4% achieved PASI90, and 22.8% achieved PASI100; 81.2% achieved PASI ≤1 and 83.2% achieved sPGA 0/1. A post hoc exploratory analysis suggested numerically higher response rates in patients with predominant small plaque morphology. Treatment was generally well tolerated, with no serious adverse events or discontinuations. Mild pruritic eruptions were infrequent and occurred mainly in individuals with atopic backgrounds.Conclusions: These findings support the real-world effectiveness and safety of deucravacitinib in Chinese patients with plaque psoriasis; morphological observations are exploratory and hypothesis-generating.

01 Oct 2026·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Real-world experience with extended deucravacitinib-biologic combination therapy in refractory psoriasis and psoriatic arthritis

Article

Author: Woll, Jack ; Cheng, Michael ; Min, Michelle S ; Di Tomasso, Pamela Maree ; Duong, Matthew ; Vikram, Ellee Pisey

01 Oct 2026·JOURNAL OF INTERNAL MEDICINE

Advances in the treatment of systemic lupus erythematosus: Biologicals, small‐molecular agents, and cell‐depleting therapies coming to the clinic

Review

Author: van Vollenhoven, Ronald

Abstract:

Systemic lupus erythematosus (SLE; lupus) remains a particular challenge for the practicing clinician on account of its chronic undulating and unpredictable course, its diverse manifestations, and—until recently—limited treatment options all associated with considerable downsides. However, a major change in this situation is currently taking place. Over the past few years, several new biological therapeutics have been approved for the treatment of SLE (belimumab and anifrolumab) or specifically for its renal organ manifestation (obinutuzumab), along with one new small molecular treatment for the latter (voclosporin). Several additional biologicals (litifilimab and dapirolizumab) and small molecules (deucravacitinib, upadacitinib, and cerenimod) are in late‐stage clinical development. Moreover, multiple case series and case reports have been published in the past years demonstrating excellent individual results following treatments aimed at fully depleting B lymphocytes using chimeric antigen receptor bearing T cells (CAR‐T cells) or bi‐specific T‐cell engagers. These reports have raised hopes that not only solid disease control, but also a more profound state of immunological reset—deep remission—can be attained in at least some patients. In this narrative review, these developments will be described, emphasizing both the promises and the challenges they bring about, leading into some predictions of where they may lead to. A reasonable expectation is that in the coming 1–2 years, several additional biologicals and small‐molecular agents will be approved for the treatment of lupus. The most important conclusion is that the future for our patients with lupus looks brighter than ever before.

333

News (Medical) associated with Deucravacitinib

28 Sep 2026

·www.biospace.com

6 immunology targets to sustain a mammoth I&I market

iStock, rudall30 Johnson & Johnson, Pfizer, Argenx and more are unlocking new immunology targets and looking to improve on existing ones in an attempt to catch some of the magic brought about by AbbVie’s Humira and Sanofi and Regeneron’s Dupixent. Aside from cancer—and in recent years, obesity—immunology is one of biopharma’s hottest therapeutic areas, producing some of the biggest franchises in the industry’s history. AbbVie’s Humira, approved for a wide range of immune-mediated conditions, was the world’s top-selling drug for nearly a decade, from 2012 to 2020 . The anti-TNF antibody was only dethroned in 2021 by Pfizer and BioNTech’s COVID-19 vaccine Comirnaty, but Humira remained a commercial juggernaut that year, slipping only to second with $20.7 billion in sales. “AbbVie remains the commercial benchmark,” Stuti Mahajan, consulting manager at DelveInsight told BioSpace in an email interview. Even as Humira drops off after losing key patent protections, Mahajan noted, the pharma has built a robust immunology portfolio with the IL-23 blocker Skyrizi and the JAK inhibitor Rinvoq, both of which were among the industry’s best-selling drugs last year . Then there’s Sanofi and Regeneron’s IL-4Rα blocker Dupixent, another immunology powerhouse approved for a wide array of indications—including asthma, urticaria and atopic dermatitis—that brought in $17.8 billion revenue in 2025 . But Dupixent, too, is nearing the end of its primary revenue years, with key U.S. exclusivity lasting into 2031 . Earnings Keytruda Hangs On to Best Seller Crown as GLP-1s Gain Ground Merck’s Keytruda will soon lose exclusivity, just as weight-loss giants Eli Lilly and Novo Nordisk press in with their blockbuster GLP-1s. March 4, 2026 · 9 min read · Tristan Manalac Read more To take advantage of these openings in the massive immunology and inflammation (I&I) market, many other drugmakers—big and small—are advancing novel and innovative mechanisms for immune-driven diseases. There are the usual Big Pharma suspects, such as Johnson & Johnson, which Mahajan contended has “the most strategically complete portfolio” with IL-23 blockers Tremfya and Icotyde plus the FcRn inhibitor Imaavy and additional programs. Bristol Myers Squibb and Merck are also challengers in the I&I space, Mahajan said. BMS is combining the TYK2-targeting Sotyktu with next-generation cell therapies, while Merck is proposing the TL1A inhibitor tulisokibart for ulcerative colitis and Crohn’s disease. Meanwhile, smaller specialists like Protagonist Therapeutics, argenx and Oruka Therapeutics are also advancing novel assets to address emerging pathologic pathways or improve upon current approaches to well-established disease drivers. Here, BioSpace looks at six of the biggest immunology targets and the companies tackling them. J&J, Argenx, more home in on FcRn Because of how central it is to autoimmune diseases, FcRn has become one of the bigger immunology targets, according to Matt Phipps, group head of biotechnology equity research at William Blair. The protein, a receptor expressed by tissues throughout the body, recycles IgG antibodies and prolongs their lifespan—in turn sustaining the activity of autoreactive antibodies. Several biopharma players have focused their drug development efforts on FcRn, Phipps told BioSpace via email. Not least of these is Johnson & Johnson, which owns Imaavy, a monoclonal antibody approved for generalized myasthenia gravis (gMG) and warm autoimmune hemolytic anemia. J&J is also testing Imaavy for systemic lupus erythematosus . Data from a Phase 2 trial demonstrated significant reduction in disease activity , according to a June readout. A late-stage study in this indication is ongoing. Imaavy is also currently in development for Sjogren’s disease, fetal and neonatal alloimmune thrombocytopenia and idiopathic inflammatory myopathy. Also in the FcRn arena is argenx. The biotech’s only commercial franchise is the FcRn inhibitor Vyvgart , approved for gMG. A subcutaneous formulation of the drug, called Vyvgart Hytrulo , is approved for gMG and chronic inflammatory demyelinating polyneuropathy. The biotech continues to study the asset in other immunology indications, such as immune thrombocytopenia and Graves’ disease. Other companies targeting FcRn include Immunovant with imeroprubart, also known as IMVT-1402 , which is in Phase 3 studies for a range of autoimmune conditions—though the company recently stopped pursuing lupus after a mid-stage failure —and UCB Pharma with the FDA-approved Rystiggo. Mahajan agrees that FcRn is currently one of the most valuable immunology targets, offering “the broadest theoretical pipeline-in-a-product potential.” STAT6 could pave path to ‘oral Dupixent’ Another immunology target attracting significant attention is STAT6 , a signaling pathway that plays a central role in the activity of B cells—the immune players that produce antibodies. Faulty regulation of this pathway is known to result in a host of disorders, such as atopic dermatitis, asthma and food allergies. STAT6 “is clearly of interest to people,” William Blair’s Phipps told BioSpace , referring to the target’s potential to produce an “oral Dupixent.” That blockbuster antibody targets IL-4 and IL-13 , both of which lie upstream of STAT6 in the immune cascade. One leader in this space is Kymera Therapeutics, which is working on the orally available degrader KT-621, being tested for atopic dermatitis and asthma. Phase 1b data presented in March demonstrated “ deep STAT6 degradation ” at both 100-mg and 200-mg dose levels in patients with moderate-to-severe atopic dermatitis, with median reductions of 94% in the skin and 98% in the blood, Kymera said at the time. The candidate also elicited “robust reductions” in several disease-relevant type 2 inflammatory blood biomarkers. The early-stage study’s primary endpoint is safety, which the March readout found to be “favorable,” according to a company presentation . There were no serious or severe adverse events, nor did any of the patients drop out due to treatment-emergent adverse events (TEAE). Data from the Phase 2b BROADEN2 study are expected by the end of this year. Also in the STAT6 race are Nurix Therapeutics and powerhouse partner Sanofi. Together, the companies are advancing the oral STAT6 degrader SAR448272/NX-3911, which last month advanced into Phase 1 development for type 2 inflammatory diseases. Sanofi in April 2025 licensed an undisclosed Nurix program targeting a previously undruggable transcription factor for autoimmune diseases for $15 million upfront and the possibility of up to $465 million in milestones. The companies first came together in December 2019 in a multi-year collaboration to advance targeted degraders in which Sanofi paid Nurix $55 million upfront. Next-gen IL-13/IL-4 blockers seek to improve on Dupixent While the STAT6 developers seek to package the Dupixent magic in a pill, another group of drugmakers is developing next-gen molecules that could improve upon the blockbuster drug’s already-impressive efficacy profile, H.C. Wainwright Senior Analyst Mitchell Kapoor told BioSpace in an email. Among the companies leading this charge are Eli Lilly and LEO Pharma, he said, which own Ebglyss and Adbry , respectively. Like Dupixent, both of these medicines are antibodies that disrupt the IL-13/IL-4 pathway and are approved to treat moderate-to-severe atopic dermatitis. Many others still in the clinic could not only improve upon Dupixent’s efficacy but also allow for less frequent dosing, Kapoor said. These include Aclaris Therapeutics’ bispecific therapy ATI-052, which blocks IL-4 and TSLP, another crucial immune signaling molecule. Phase 1a data in January showed favorable safety outcomes for the asset, as well as a potential “best-in-class” pharmacokinetic profile, according to the biotech. Aclaris expects topline data from Phase 1b proof-of-concept trials in atopic dermatitis and asthma in the second half of this year. Kapoor also pointed to Sanofi, which is taking a similar approach with the bispecific therapy lunsekimig, which works by targeting TSLP and IL-13. In April, the company announced mid-stage data showing that lunsekimig improved symptom burden in patients with asthma and rhinosunisitis, but failed to ease severity in a Phase 2b trial of atopic dermatitis. Sanofi is also testing the asset for chronic obstructive pulmonary disease (COPD). Pfizer, meanwhile, is developing the trispecific molecule tilrekimig, which targets IL-13, IL-4 and TSLP. A Phase 2 readout in March demonstrated statistically significant improvements in eczema severity at 16 weeks, encouraging the pharma to advance the asset into late-stage studies for atopic dermatitis in 2026. Tilrekimig is also being studied for asthma and COPD. Drug development Sanofi Bispecific Scores in Asthma, Rhinosinusitis, but Eczema Bet Doesn’t Pay Off Sanofi has faced questions about the potential of lunsekimig in eczema, with executives calling the clinical trial a “measured risk.” April 7, 2026 · 2 min read · Annalee Armstrong Read more IL-17/IL-23 still fertile for innovation after several approvals Arguably among the most-addressed disease drivers in the immunology space are IL-17 and IL-23 , cytokines that lie close to each other on the inflammation signaling cascade. Secreted by immune cells in response to certain stimuli, IL-23 is more upstream and works to activate helper T cells, which in turn produce IL-17. Both cytokines help kick off the inflammatory response—and therefore offer attractive opportunities for drugmakers to intervene. Indeed, some of the industry’s biggest immunology players and franchises target IL-23 or IL-17, including Novartis’ Cosentyx , Johnson & Johnson’s Tremfya and AbbVie’s Skyrizi . But while there are already several drugs on the market addressing these targets, Phipps argued that there is still a lot of room for development in the space as companies make headway with oral options. H.C. Wainwright’s Kapoor agreed, pointing in particular to IL-23, which he said “remains attractive” as the lead target in psoriasis as novel products emerge with more convenient dosing schedules. In March, for instance, J&J won the FDA’s approval for Icotyde, an oral IL-23 receptor blocker indicated for severe plaque psoriasis. There’s also Takeda, which is developing zasocitinib, an oral drug that inhibits IL-23 signaling. Zasocitinib is under FDA review for moderate-to-severe plaque psoriasis with a decision expected early next year. Meanwhile, Ascletis Pharma is advancing an investigational oral IL-17 inhibitor called ASC50 for psoriasis. Phase 1 data presented in December 2025 showed strong target engagement, painting what CEO Jinzi Jason Wu claimed is a “best-in-class” profile. But even as pills start entering the market, “Skyrizi’s continued growth is pushing back on the idea that oral drugs will inevitably displace injectable biologics,” Kapoor said. “Patients continue to choose injections because infrequent dosing can actually be more convenient than taking a pill every day.” This is especially true for patients with controlled disease, he noted, who want to think about their conditions “as little as possible.” Oruka Therapeutics is pushing this particular hypothesis to a “logical extreme,” he continued, with its injectable IL-23 inhibitor ORKA-001 that could potentially be dosed once a year, according to the biotech . The asset set to enter Phase 3 development in the first half of 2027 . Approvals J&J Wins FDA Nod for First Targeted Oral Anti-IL-23 Therapy for Plaque Psoriasis Icotyde, co-developed by Johnson & Johnson and Protagonist Therapeutics, is backed by data from the Phase 3 ICONIC program, which, among other advantages, showed significant superiority over Bristol Myers Squibb’s Sotyktu. March 18, 2026 · 2 min read · Tristan Manalac Read more

Drug ApprovalPhase 2Clinical ResultPhase 1Phase 3

24 Sep 2026

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European Commission approval of ICOTYDE™▼(icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide

Johnson & Johnson introduces the first IL-23R targeted oral peptide that can deliver skin clearance and a favourable safety pro a once-daily pill. 1,2 ICOTYDE™ (icotrokinra) offers an innovative new option for eligible patients with moderate-to-severe plaque psoriasis to address patients cycling on topical therapies in need of systemic treatment. 1,2 BEERSE, BELGIUM (21 Sept 2026) – Johnson & Johnson today announced that the European Commission (EC) has granted approval for the Marketing Authorisation of ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of adults and adolescent patients (aged ≥12 years and weighing ≥40 kg) with moderate-to-severe plaque psoriasis (Pso) who are candidates for systemic therapy. 1 Icotrokinra is the first targeted oral peptide that precisely blocks the IL-23 receptor. 2,3,4 “For many people living with moderate-to-severe plaque psoriasis, the burden of disease remains substantial, but currently available systemic treatments do not consistently meet patients' treatment needs. There remains an ongoing unmet need for additional treatment options, regardless of route of administration.” said Lluís Puig, Professor of Dermatology, Universitat Autònoma de Barcelona. a “The approval of icotrokinra marks an important evolution in plaque psoriasis treatment. As the first targeted oral peptide designed to precisely block the IL-23 receptor, it combines high levels of skin clearance, a favourable safety profile, and the convenience of once-daily oral administration.” Clinical evidence summary Icotrokinra met all primary efficacy endpoints and demonstrated a favourable safety pro four Phase 3 studies including 2,500 patients. 1,2 The EC decision is supported by an unprecedented breadth of evidence within the Phase 3 ICONIC clinical development programme, which simultaneously evaluated icotrokinra in adults and adolescents aged 12 and older and weighing at least 40 kg with moderate-to-severe plaque Pso. 1 The programme included patients with involvement of high-impact sites such as scalp and genital Pso, and two head-to-head studies versus an active comparator. 1,5 In the head-to-head studies, approximately 70% of patients treated with icotrokinra achieved clear or almost clear skin, as measured by IGA 0/1, and 55% achieved a PASI 90 response at Week 16. 5,b,c Rates of adverse reactions for icotrokinra treated patients were within 1.1% of placebo rates through Week 16 and no new safety signals were observed through Week 52. 1,2,6 “The approval of icotrokinra represents a defining milestone for eligible people living with moderate-to-severe plaque psoriasis,” said Mark Graham, Therapeutic Area Head, Immunology, J&J Innovative Medicine EMEA. “At Johnson & Johnson, we are committed to pushing the boundaries of science to address persistent unmet needs in immunodermatology. As the first targeted oral peptide to block the IL-23 receptor, icotrokinra represents a landmark scientific advance and has the potential to transform the treatment paradigm of plaque psoriasis for patients.” Unmet need in moderate-to-severe plaque psoriasis An estimated 6.4 million people in Europe live with plaque psoriasis, 7 a chronic condition that can significantly impact physical comfort, emotional wellbeing and quality of life, especially when lesions are on visible or sensitive areas. 8 For many with moderate-to-severe disease, targeted systemic treatments are key. 9,10 Most people living with moderate-to-severe plaque psoriasis are eligible for, but are not receiving, systemic treatment. 9,10 An oral therapy that selectively inhibits the IL-23 pathway by directly targeting the IL-23 receptor could help address the unmet needs and preferences of patients. 1,9,10 This aligns with International Psoriasis Council guidance to transition to systemic therapy if two cycles of topical medications applied for four weeks fail to bring meaningful improvement. 11 Johnson & Johnson is committed to helping address the significant unmet need in moderate-to-severe plaque Pso and is working with relevant stakeholders across Europe to support the introduction of icotrokinra and help enable patient access. Editor’s notes: a. Dr. Lluís Puig is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. b. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease. 12 c. The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness. PASI 90 corresponds to an improvement of ≥ 90% in PASI score from baseline. 13 About the ICONIC Clinical Development Programme The pivotal Phase 3 ICONIC clinical development programme is ongoing to evaluate the safety and efficacy of icotrokinra in adults and adolescents (12 years of age and older) with moderate-to-severe plaque psoriasis. 14 The following studies are part of this programme: ICONIC-LEAD ( EUCT: 2023-505120-59-00 ; NCT06095115 ) is a Phase 3 randomised controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 12 years of age or older with moderate-to-severe plaque psoriasis, with the higher efficacy bar of PASI c 90 and IGA b score of 0/1 with at least a 2-grade improvement vs placebo at week 16 as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients. 2,15 ICONIC-TOTAL ( EUCT: 2023-505122-34 ; NCT06095102 ) is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque psoriasis in 311 participants (icotrokinra=208; placebo=103) with at least 1% body surface area involvement, at least mild disease (global IGA of 2 or higher), and at least moderate severity affecting high-impact sites (e.g., scalp, genital, and/or hands and feet). 2,16,17 The primary endpoint was the proportion of patients with overall IGA score of 0 or 1 with at least a 2-grade improvement vs placebo at week 16 as the primary endpoint. 16,17 ICONIC-ADVANCE 1 ( EUCT: 2023-507039-39-00 ; NCT06143878 ) and ICONIC-ADVANCE 2 ( EUCT: 2023-505121-14 ; NCT06220604 ) are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque psoriasis with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement versus placebo at week 16 as co-primary endpoints. 18,19 Additional studies underway in other disease areas include: ICONIC-PsA 1 ( EUCT: 2023-509239-19-00 ;NCT06878404) and ICONIC-PsA 2 ( EUCT: 2024-517284-23-00 ; NCT06807424 ) in active psoriatic arthritis;ICONIC-UC ( EUCT: 2025-521381-10-00 ; NCT071196748 ) in moderately-to-severely active ulcerative colitis; and ICONIC-CD ( EUCT: 2025-521382-27-00 ; NCT7196722 ) in moderately-to-severely active Crohn’s disease. 20,21,22,23 About Plaque Psoriasis Plaque psoriasis is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. 8,24 It is estimated that 6.4 million people in Europe 7 and more than 125 million people worldwide live with the disease. 25 Nearly one-quarter of all people with plaque psoriasis have cases that are considered moderate-to-severe. 24 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. 24 Plaques may appear red in lighter skin or more of a purple, grey or dark brown colour in patients with darker skin tones. 24 Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso. 24 Living with plaque psoriasis can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life. 26 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life. 26,27 About icotrokinra (JNJ-77242113, JNJ-2113) Icotrokinra is the first-in-class targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque psoriasis. 2,28,29 Icotrokinra binds to the IL-23 receptor with high affinity and demonstrated potent, selective inhibition of IL-23 signalling in human T cells. 3,4 Clinical significance of these findings is unknown. Icotrokinra has been approved by the European Commission for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older and weighing at least 40 kg, who are candidates for systemic therapy. 1 Patients on icotrokinra take one pill, once daily with water upon waking, at least 30 minutes prior to eating food. 1 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. 30 Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialise compounds derived from the research conducted pursuant to the agreement against a broad range of indications. 30,31,32,33 Icotrokinra is also being studied in active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn’s disease. 34,35,36 ▼ In line with EMA regulations for new medicines and those given conditional approval, icotrokinra is subject to additional monitoring. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. CP-598262 September 2026 ### 1. ICOTYDE EU Prescribing Information 2. Lebwohl M, Gooderham M, et al. Safety of Icotrokinra Through 1 Year for the Treatment of Moderate-to-Severe Plaque Psoriasis and Psoriasis Affecting High-Impact Sites: Pooled Results Across the ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2 Phase 3 Trials. Dermatol Ther. 2026; . Accessed September 2026. 3. Bissonnette R, et al. An Oral Interleukin-23-Receptor Antagonist Peptide for Plaque Psoriasis. N Engl J Med. 2024 Feb 8;390(6):510-521. doi: 10.1056/NEJMoa2308713. PMID: 38324484. Accessed August 2026. 4. Fourie A, et al. JNJ-77242113, a highly potent, selective peptide targeting the IL-23 receptor, provides robust IL-23 pathway inhibition upon oral dosing in rats and humans. Sci Rep. 2024; 14(1), 17515. . Accessed August 2026 5. Stein Gold, L et al. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025;406(10510):1363-1374. doi:10.1016/S0140-6736(25)01576-4. Accessed August 2026. 6. Soung, J et al. Maintenance of Response with Icotrokinra, a Targeted Oral Peptide, for the Treatment of Moderate-to-Severe Psoriasis : Randomized Treatment Withdrawal in Adults (weeks 24- 52) and Continuous Treatment in Adolescents (Through Week 52) From the Phase 3, ICONIC-LEAD Trial. Late-breaking research oral presentation (Presentation #D1T01.2B) at the European Academy of Dermatology and Venereology Congress (EADV). September 2025. Accessed August 2026 7. University College Dublin. HPOS: UCD study recruits thousands with aim of predicting cases of psoriatic arthritis. Available at: . Accessed June 2026. 8. National Psoriasis Foundation. About Psoriasis. Available at: . Accessed August 2026. 9. Lebwohl M, Langley RG, Paul C, Puig L, Reich K, van de Kerkhof P, et al. Evolution of patient perceptions of psoriatic disease: results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey. Dermatol Ther (Heidelb). 2022;12(1):61-78. doi:10.1007/s13555-021-00635-4. Accessed August 2026. 10. Data on File. Janssen. Decision Resources & Internal Claims Research. Truven Health Analytics Data. 11. Strober BE, Blauvelt A, van de Kerkhof PCM, et al. Establishing consensus on defining failure of topical therapy in psoriasis: Recommendations from the International Psoriasis Council. J Am Acad Dermatol. 2025. . Accessed August 2026. 12. Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis J Am Acad Dermatol. 2020; doi: 10.1016/j.jaad.2020.04.104. Accessed August 2026. 13. Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: . Accessed August 2026. 14. Protagonist Therapeutics. Press Release. Protagonist Therapeutics Announces Advancement of JNJ-2113 Across Multiple Indications. Available at: . Accessed August 2026. 15. Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. . Accessed June 2026. 16. Health Research Authority. A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis involving Special Areas. EUCT number: 2023-505122-34. Available at: . Accessed June 2026. 17. Clinicaltrials.gov. A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. . Accessed August 2026. 18. Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. Accessed June 2026. 19. Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. Available at: . Accessed June 2026. 20. Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. . Accessed August 2026. 21. Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. . Accessed August 2026. 22. Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately-to-Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. . Accessed August 2026. 23. Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately-to-Severely Active Crohn’s Disease (ICONIC-CD). Identifier NCT07196722. . Accessed January 2026. 24. National Psoriasis Foundation. Plaque Psoriasis. Available at: . Accessed June 2026. 25. National Psoriasis Foundation. Psoriasis Statistics. Available at: . Accessed June 2026. 26. National Psoriasis Foundation. Life with Psoriasis. Available at: . Accessed June 2026 27. National Psoriasis Foundation. High Impact Sites. Available at: . Accessed June 2026. 28. Razawy W, et al. The role of IL-23 receptor signaling in inflammation-mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229. Accessed June 2026. 29. Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 30. Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: . Accessed June 2026. 31. Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: . Accessed June 2026 32. Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: . Accessed June 2026. 33. Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: . Accessed June 2026. 34. Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. . Accessed August 2026. 35. Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately-to-Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. . Accessed August 2026. 36. Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease (ICONIC-CD). Identifier NCT07196722. . Accessed August 2026. CONTACT: Media contact: Sophie Daneau SDaneau@ITS.JNJ.com Investor contact: Jessica Margevich investor-relations@its.jnj.com

Phase 3Clinical ResultDrug ApprovalLicense out/inPhase 2

22 Sep 2026

·www.biopharmadive.com

Amgen reports a Phase 3 win with Sjögren’s drug candidate

Dive Brief:An experimental Amgen drug has succeeded in the first of two Phase 3 trials in Sjgren's syndrome, driving the California biotechnology giants stock price up as much as 5% on Tuesday.Amgen didnt provide specific details about the performance of its drug dazodalibep. But it said in a Tuesday statement that treatment led to a statistically significant and clinically meaningful improvement on a widely used measure of disease activity after 48 weeks, meeting the trials primary objective. Positive effects were observed as early as four weeks after treatment and persisted through the evaluation period, Amgen said.Investigators didnt spot an imbalance in the rate of blood clots or opportunistic infections in the Phase 3 study, a potential concern of drugs with dazodalibeps mechanism. Side effects were generally mild to moderate, and study discontinuations were infrequent and balanced across study arms, the company said.Dive Insight:Sjgrens has been a tricky target for drugmakers. There are no approved treatments that can alter the course of the condition, in which the immune system errantly attacks moisture-producing glands and causes chronic dry eyes and mouth, pain, inflammation and other health problems. Patients have a higher risk of lymphoma as well.Dazodalibep interferes with a key communication channel between immune cells. Blocking this CD40-CD40L pathway is meant to blunt the hyperactive immune response and formation of tissue-damaging autoantibodies in Sjgrens. The approach showed promise in earlier testing, with participants in a Phase 2 trial experiencing a reduction in symptoms and disease activity.The drug came to Amgen after changing hands multiple times. It was originally discovered by AstraZeneca, which spun it into a startup, Viela Bio, that Horizon Therapeuticsacquired in 2021. Amgen then bought Horizon two years later, inheriting dazodalibep along with multiple other prospects.Dazodalibep is now among the more closely watched prospects in Amgens pipeline. The results announced Tuesday come from the first of two pivotal studies in Sjgrens. The second, in patients who have a high symptom burden, is expected to produce data in the fourth quarter.“These topline results provide further support for dazodalibep as an emerging treatment for improving systemic disease activity and represent an important advance for the field, Ghaith Noaiseh, the studys lead investigator and an immunology professor at the University of Kansas Medical Center, said in a statement provided by Amgen.Without detailed findings theyll be disclosed at a future medical meeting its not yet clear how Amgens drug stacks up against other emerging competitors. Novartis has an experimental therapy called ianalumab that could be cleared by regulators this quarter. Bristol Myers Squibb is also due to report Phase 3 data testing its drug Sotyktu, a marketed treatment for psoriasis, in Sjgrens.The study specifics Amgen eventually presents will help inform positioning against ianalumab, wrote David Risinger, an analyst at Leerink Partners, in a note to clients. Risinger added that his team and other analysts have very low expectations for Bristol Myers study.In a separate note,William Blair analyst Matt Phipps wrote that he was encouraged by the announcement given his team has viewed the dazodalibep program as relatively high risk. He cautioned, though, that Amgens two Phase 3 trials involve distinct patient populations and the company will need victories in both studies to win regulatory approval. '

Phase 3Phase 2Clinical ResultAcquisition

100 Deals associated with Deucravacitinib

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Arthritis, Psoriatic	United States	Bristol Myers Squibb Co.	06 Mar 2026
Erythrodermic psoriasis	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Psoriasis vulgaris	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Pustular psoriasis	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Plaque psoriasis	United States	Bristol Myers Squibb Co.	09 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psoriasis of scalp	Phase 3	-	Bristol Myers Squibb Co.	31 Dec 2026
Sacroiliac disorder	Phase 3	-	Bristol Myers Squibb Co.	31 Dec 2026
Salivary Gland Adenoma, Pleomorphic	Phase 3	-	Bristol Myers Squibb Co.	31 Dec 2026
Juvenile Idiopathic Arthritis	Phase 3	United States	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	China	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Brazil	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Bulgaria	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Czechia	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Germany	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Italy	Bristol Myers Squibb Co.	13 Mar 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06512337 (Pubmed \| J Dermatolog Treat)	Phase 4	Plaque psoriasis	101	Deucravacitinib 6 mg	ubksngxsmh(rmhcjmvjil) = vhpwfzjwlb cqrnfkehqb (zmakdoirwo ) View more	Positive	31 Dec 2026
NCT06444399 (CTgov)	Phase 2	Pityriasis Rubra Pilaris	7	Deucravacitinib	pnercxkact(xxwkluvjwi) = jfgvozkaze bukkwiksdj (iopcndkmtt, 12.9) View more	-	26 Aug 2026
NCT03624127 \| NCT04036435 \| NCT03611751 (POETYK PSO-1, Pubmed \| Am J Clin Dermatol)	Phase 3	Plaque psoriasis	1,519	Deucravacitinib 6 mg once daily	tulwvrwlof(fwuqlvrbtc) = lgvqfsjkqv ihlmrgamie (ldfqrrwjbr ) View more	Positive	07 Aug 2026
EULAR2026	Phase 2/3	Arthritis, Psoriatic	7,147	-	qopoazwdqn(izaaejjkcj) = zpkubnjjtf omcrjgulwt (pwjtkshvyn )	Positive	11 Jun 2026
				deucravacitinib (ACR50)	jfrwrujgck(vaimgwefun) = pgsbhgpzks etnariqncc (wfuceafkvl )
NCT04908189 (POETYK PSA-2, EULAR2026)	Phase 3	Arthritis, Psoriatic	1,519	Deucravacitinib 6 mg once daily	ghwzkvyqmf(igacmighkm) = plptbhvzwn kmtbahrtjz (wwzrvjvmma ) View more	Positive	11 Jun 2026
				Placebo switched to deucravacitinib	ghwzkvyqmf(igacmighkm) = lpcfpztqny kmtbahrtjz (wwzrvjvmma ) View more
NCT07280702 (COMBo, EULAR2026)	Phase 4	-	128	Deucravacitinib 6 mg + TNFi	malzftndmk(kxkvsijlzx) = cikppdvrpi izwwhbcysl (lyplsedxfk )	Positive	11 Jun 2026
				Placebo + TNFi	macwkiubrm(pfsrlfsacw) = pasnbrcyyg ayqigsaadd (mhtgnupmha ) View more
NCT03252587 (PAISLEY SLE, EULAR2026)	Phase 2	Systemic Lupus Erythematosus	277	Deucravacitinib 3 mg BID	lgxiyhioxo(qycljlcfhw) = esfnfhhglf dpanmdwsoe (tnymaegdzs ) View more	Positive	11 Jun 2026
				Deucravacitinib 6 mg BID	shbyinojih(wiaehrnxcp) = ufknebltrs dnkyfaspkr (jayltvujas ) View more
NCT05997277 (CTgov)	Phase 2	Hidradenitis Suppurativa	7	Deucravacitinib (Deucravacitinib - Study Drug)	guntfekivj(uxifyhlomz) = bigevzotht zpruhrvdgx (giffpzarwu, bwpjnnjeht - anlibfciud) View more	-	29 May 2026
				Placebo (Placebo)	guntfekivj(uxifyhlomz) = dnreklqjll zpruhrvdgx (giffpzarwu, nhqcjqlike - bmddpybdpr) View more
NCT06333860 (IMMpactful, Pubmed \| Dermatol Ther (Heidelb))	Phase 4	Plaque psoriasis	150	Risankizumab 150 mg	ztgcsnmqke(wtoipcjcjg) = qzdwyqztlh lpgotefpwc (rkidknqnqf ) View more	Positive	17 May 2026
				Deucravacitinib 6 mg	ztgcsnmqke(wtoipcjcjg) = khjsbjyvrw lpgotefpwc (rkidknqnqf ) View more
NCT06042920 (PSORIATYK Special Sites, CTgov)	Phase 4	Pustulosis of Palms and Soles	130	BMS-986165 (Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD)	mumidpngui = jlbifmdlka ocpwsiyvja (offknhjyid, uwftxtdocm - znnwhdsrwd) View more	-	17 Apr 2026
				Placebo (Placebo Contolled - Palmoplantar Psoriasis - Placebo)	mumidpngui = btpshrpmzj ocpwsiyvja (offknhjyid, oenlptnfxf - eymdddxmll)

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