An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects

The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.

Start Date06 Aug 2024

Sponsor / Collaborator

Amgen, Inc.

NCT06527404

/ Active, not recruitingPhase 3

A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

Start Date18 Jul 2024

Sponsor / Collaborator

Amgen, Inc.

NCT06376045

/ Active, not recruitingPhase 2

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

Start Date24 May 2024

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Rocatinlimab

100 Translational Medicine associated with Rocatinlimab

100 Patents (Medical) associated with Rocatinlimab

Literatures (Medical) associated with Rocatinlimab

01 Feb 2026·Dermatology and Therapy

Psychometric Evaluation of Worst Pruritus Numeric Rating Scale in Adults With Moderate-to-Severe Atopic Dermatitis

Article

Author: Blauvelt, Andrew ; Williams, Angela ; McLeod, Lori ; Deininger, Kimberly M ; Qin, Shanshan ; Nelson, Lauren

INTRODUCTION:

Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a hallmark symptom of pruritus. We developed Worst Pruritus Numeric Rating Scale (NRS)-a single-item, patient-reported outcome measure-to assess itch severity in clinical trial populations of adults with moderate-to-severe AD. The objective of this study was to evaluate the psychometric properties of Worst Pruritus NRS and determine its appropriateness for use in clinical trials assessing the efficacy of treatments among adults with moderate-to-severe AD.

METHODS:

We used data from a subset of 267 participants in a phase 2 clinical trial of rocatinlimab (NCT03703102; N = 274) to confirm reliability, validity, and ability to detect change in Worst Pruritus NRS. We estimated and confirmed a meaningful within-patient change (MWPC) threshold using anchor- and distribution-based methods.

RESULTS:

All intraclass correlation coefficients (ICCs) were ≥ 0.86, providing robust evidence for test-retest reliability. Evidence supported construct validity, including known-groups validity (all P < 0.0001). There were moderate, positive correlations between scores on Worst Pruritus NRS and supportive measures at week 16, including Dermatology Life Quality Index (DLQI) question 1 (itch item) (r = 0.78), DLQI (r = 0.66), Eczema Area and Severity Index (EASI) (r = 0.50), Investigator's Global Assessment (IGA) (r = 0.46), Body Surface Area of Involvement (BSA) (r = 0.40), and SCORing Atopic Dermatitis (SCORAD) itch item (r = 0.97). On average, patients with better DLQI question 1 scores, EASI, and IGA classifications achieved better (i.e., lower) scores on Worst Pruritus NRS at week 16 (P < 0.0001). Ability to detect change was supported with moderate-to-strong and positive correlations between Worst Pruritus NRS change scores and changes in supporting measures. MWPC estimates confirmed the commonly applied 4-point threshold value and a range of 3 to 4 points as indicative of meaningful within-patient change.

CONCLUSIONS:

Worst Pruritus NRS is a reliable and valid patient-reported outcome measure to assess itch severity in clinical trial settings among adults with moderate-to-severe AD.

01 Feb 2026·JOURNAL OF INVESTIGATIVE DERMATOLOGY

Molecular differentiation of OX40 and OX40L targeted biologics using AlphaFold3 and molecular dynamics simulations

Article

Author: Nolden, Kelsey ; Batista, Victor S ; Shi, Yuanjun ; Bunick, Christopher G

Atopic dermatitis is a chronic inflammatory skin disorder that affects over 200 million people worldwide. Although disease etiology is multifaceted, the immune checkpoint molecules OX40 and OX40L have a critical role in disease development. Recent clinical trials demonstrated that the OX40-targeting antibodies rocatinlimab (KHK4083/AMG-451) and telazorlimab (GBR-830/ISB-830), and the OX40L-targeting antibody amlitelimab (KY1005), significantly improve symptoms of atopic dermatitis. However, the epitopes where these antibodies bind OX40 and OX40L remain unclear, and therefore, so do the mechanisms by which they specifically disrupt OX40-OX40L signaling. To address this, computational modeling was performed to predict antibody-protein co-complexes, and their interaction interfaces were characterized. Binding free energy of specific OX40 or OX40L residue-residue interactions within 5 Å of the antibody binding interface were analyzed using MM-PBSA with a per-residue energy decomposition analysis. Our analysis suggests rocatinlimab and amlitelimab directly inhibit OX40-OX40L interactions by physically blocking the cognate OX40-OX40L interface via steric occlusion, whereas telazorlimab disrupts a critical OX40-OX40L bond. Together, this work provides molecular characterization of the epitopes of OX40 and OX40L targeted biologics emerging in dermatology.

01 Jan 2026·LANCET

Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials

Article

Author: Herranz-Pinto, Pedro ; Stein Gold, Linda ; Chovatiya, Raj ; Hong, H Chih-Ho ; Schwartz-Sagi, Liat ; Bissonnette, Robert ; Worm, Margitta ; Arai, Takahiro ; Kern, Johannes S ; Yang, Yiping ; Luna, Paula C ; Magnolo, Nina ; Guttman-Yassky, Emma ; Bernstein, Jonathan A ; Ehst, Benjamin D ; Kabashima, Kenji ; Barragan, Carolina ; Shi, Rebecca ; Kricorian, Greg ; Esfandiari, Ehsanollah ; Sofen, Howard ; Pink, Andrew E

BACKGROUND:

Rocatinlimab is a T cell rebalancing therapy that inhibits and reduces the number of pathogenic T cells by targeting the OX40 receptor expressed on the surface of activated T cells. Two global phase 3 studies were performed to assess the efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in adults.

METHODS:

ROCKET-IGNITE (IGNITE) and ROCKET-HORIZON (HORIZON) were 24-week randomised, double-blind, placebo-controlled phase 3 trials conducted in 19 countries each. Eligible patients were 18 years and older with confirmed atopic dermatitis (American Academy of Dermatology Consensus Criteria) diagnosed 1 year or longer before study entry with moderate-to-severe disease activity, defined by an Eczema Area and Severity Index (EASI) score of 16 and over, validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 (moderate) or 4 (severe), and affected body surface area of 10% and above. In IGNITE, patients were randomly allocated in a 3:2:2 ratio to receive subcutaneous 300 mg rocatinlimab, 150 mg rocatinlimab, or placebo; in HORIZON, patients were randomised 3:1 to receive subcutaneous 300 mg rocatinlimab or placebo. Randomisation was stratified by baseline disease severity (vIGA-AD score of 3 vs 4) and geographical region (Japan vs non-Japan Asian countries vs rest of world). Across both trials, 24-week treatment was administered at weeks 0, 2, and 4 and then every 4 weeks thereafter with the last dose at week 20. The coprimary endpoints for both trials were EASI-75 response (≥75% improvement in EASI score from baseline) at week 24 and vIGA-AD score of 0 or 1 (defined as a score of 0 [clear skin] or 1 [almost clear skin], representing a ≥2-point improvement from baseline) at week 24. Rescue therapy use, including topical therapy, phototherapy, and systemic therapy, was permitted from day 1; all patients who received rescue therapy were considered non-responders for all visits after the first use of rescue therapy but could generally continue study treatment unless prohibited per protocol. Efficacy analyses were conducted in all randomised patients; safety analyses were conducted in all patients who received one or more dose of study treatment, with patients grouped according to actual treatment received. The trials were registered at ClinicalTrials.gov: ROCKET-IGNITE (NCT05398445) and ROCKET-HORIZON (NCT05651711).

FINDINGS:

Between May 31, 2022, and June 12, 2024, 769 patients were randomised in IGNITE (two patients were enrolled under an earlier protocol before study re-design and excluded from the analysis; after the protocol update, 328 were included in the 300 mg rocatinlimab group; 217 in the 150 mg rocatinlimab group; and 222 in the placebo group) and between Dec 14, 2022, and Dec 12, 2023, 726 patients were randomised in HORIZON (543 in 300 mg rocatinlimab and 183 in placebo). Both trials met their coprimary endpoints. Rocatinlimab treatment resulted in statistically significant improvements in EASI-75 response in comparison with placebo at week 24 in IGNITE (138 [42%] of 326 patients on 300 mg rocatinlimab; 78 [36%] of 215 on 150 mg rocatinlimab; and 28 [13%] of 219 on placebo; percentage difference vs placebo: 300 mg rocatinlimab 29·5% [95% CI 22·3-36·1], p<0·001 and 150 mg rocatinlimab 23·4% [15·4-30·9], p<0·001) and HORIZON (rocatinlimab, 178 [33%] of 543 vs placebo, 25 [14%] of 183; percentage difference 19·1% [95% CI 12·4-25·2], p<0·001). Statistically significant improvements with rocatinlimab treatment in comparison with placebo were also observed at week 24 for vIGA-AD score of 0 or 1 response in IGNITE (77 [24%] of 326 patients on 300 mg rocatinlimab; 41 [19%] of 215 patients on 150 mg rocatinlimab; and 19 [9%] of 219 patients on placebo; percentage difference vs placebo 14·9% [95% CI 8·8-20·6], p<0·001 for 300 mg rocatinlimab and 10·3% [3·8-16·6], p=0·002 for 150 mg rocatinlimab) and HORIZON (105 [19%] of 543 for 300 mg rocatinlimab vs 12 [7%] of 183 for placebo; percentage difference 12·8% [95% CI 7·6-17·3], p<0·001). The incidences of treatment-emergent adverse events were generally similar across rocatinlimab and placebo treatment groups in IGNITE and HORIZON. The most frequently reported adverse events in patients receiving rocatinlimab (defined as occurring in ≥4% of patients in any rocatinlimab treatment group and at a rate ≥2 times that of placebo) included pyrexia (105 [12%] of 870 for 300 mg rocatinlimab and 26 [12%] of 214 for 150 mg rocatinlimab), chills (48 [6%] of 870 and five [2%] of 214 for the 300 mg and 150 mg doses, respectively), and aphthous ulcers (38 [4%] of 870 and six [3%] of 214, respectively). Most events of pyrexia and chills were considered injection-related reactions; events were generally mild or moderate in severity and primarily occurred after the first dose. Serious adverse events were reported in 2% to 5% of patients in the rocatinlimab groups and 4% to 6% of patients in the placebo groups. No deaths were reported.

INTERPRETATION:

Rocatinlimab treatment resulted in statistically significant and clinically meaningful improvements across clinical endpoints, including the coprimary endpoints of EASI-75 response and vIGA-AD score of 0 or 1, in comparison with placebo and had a clinically acceptable safety profile in adult patients with moderate-to-severe atopic dermatitis.

FUNDING:

Amgen and Kyowa Kirin.

102

News (Medical) associated with Rocatinlimab

30 Mar 2026

·endpoints.news

Sanofi reports underwhelming Phase 3 OX40 data in eczema, second case of Kaposi’s sarcoma

Sanofi on Saturday shared more mixed efficacy results from a Phase 3 atopic dermatitis program for its anti-OX40 ligand monoclonal antibody, further eroding Wall Street’s already waning confidence in the candidate. The French pharma also revealed that one more patient treated with amlitelimab developed Kaposi’s sarcoma, a type of vascular tumor, bringing the total to two cases across the drug’s development history. Sanofi tested amlitelimab in three Phase 3 trials known as COAST 1, COAST 2 and SHORE, with topline results reported in recent months . The company has suggested the drug could be a successor to its Regeneron-partnered medicine Dupixent, which is nearing a patent cliff in 2031. But Saturday data presented at the American Academy of Dermatology’s annual meeting in Denver suggested weaker efficacy for amlitelimab compared with Dupixent, Leerink analysts wrote Sunday. At 24 weeks, in the US-specific primary endpoints in the COAST 1 and COAST 2 trials, almost 23% and 26% of patients, respectively, who were given amlitelimab once every three months had achieved clear or almost clear skin and a minimum two-point reduction on a symptom scale called the validated Investigator Global Assessment for Atopic Dermatitis, or vIGA-AD. This worked out to a roughly 10 to 13 percentage-point difference from placebo across the two studies. With the caveat of cross-trial comparisons, Dupixent achieved a 28 percentage-point difference from placebo in the same vIGA-AD endpoint at 16 weeks, according to data pooled across its own registrational program. Nonetheless, the three-month regimen for amlitelimab is of interest because it is more convenient than Dupixent, which is given much more frequently at once or twice a month. In response to Saturday’s data, the Leerink analysts slashed their 2032 sales projections for amlitelimab from €1.3 billion ($1.49 billion) to €650 million ($746 million). Sanofi’s shares dipped 2% on the Paris exchange Monday. The OX40 drug development space has gone through some tough times lately. Amgen in January exited its partnership with Kyowa Kirin on rocatinlimab, with the drug later reported as being associated with two confirmed and one unconfirmed cases of Kaposi’s sarcoma in total. Kyowa later dropped the drug, which binds to the OX40 receptor. Meanwhile, Sanofi had “pipeline-in-a-product” ambitions for amlitelimab, but has since dropped trials in alopecia areata, celiac disease and systemic sclerosis, and is now only advancing the drug in eczema. As for the second case of Kaposi’s sarcoma, the patient was an older man enrolled in the Phase 3 ESTUARY extension study and had “known risk factors,” although Sanofi did not disclose what they were. Both amlitelimab patients who developed Kaposi’s sarcoma discontinued treatment and are now recovering, Sanofi said Saturday. The Leerink analysts said some research has shown that OX40L may play a role in immunity to a virus called HHV-8, which is known to induce Kaposi’s sarcoma.

Phase 3Clinical Result

30 Mar 2026

·allsci.com

Sanofi’s amlitelimab meets Phase III endpoints in atopic dermatitis with extended 12-week dosing interval

Sanofi (NASDAQ: SNY) reported Phase III data from three trials of amlitelimab in moderate-to-severe atopic dermatitis, showing that the anti-OX40L antibody met primary endpoints across monotherapy and combination settings — with efficacy at a dosing interval of once every 12 weeks that matched the every-four-week regimen. The results, presented as late-breaking research at the 2026 American Academy of Dermatology annual meeting in Denver, position amlitelimab as a mechanistically distinct entrant into a treatment landscape that has grown crowded but remains defined by frequent dosing and incomplete responses. The COAST 1 and COAST 2 trials were randomized, double-blind, placebo-controlled Phase III studies evaluating amlitelimab monotherapy in adults and adolescents aged 12 and older with moderate-to-severe atopic dermatitis. SHORE used the same design but tested amlitelimab in combination with topical corticosteroids, with or without topical calcineurin inhibitors. Across the three trials, 1,786 patients were enrolled at sites spanning North America, Europe, Asia, and Latin America. The primary endpoint for all three studies was the proportion of patients achieving a validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) score of 0 or 1 — clear or almost clear skin — with at least a two-point reduction from baseline at Week 24. Both the Q4W and Q12W amlitelimab arms met this endpoint in each trial.For US and US reference countries, the primary endpoint was vIGA-AD 0/1 with a ≥2-point reduction. Of note, for the EU reference countries and Japan, the studies used co-primary endpoints that included the same vIGA-AD measure plus EASI-75. In COAST 1, vIGA-AD 0/1 rates were 21.1% (Q4W) and 22.5% (Q12W) versus 9.2% for placebo. EASI-75 — the proportion of patients achieving at least 75% improvement in the Eczema Area and Severity Index — reached 35.9% and 39.1% in the Q4W and Q12W arms, respectively, compared to 19.1% for placebo. Itch reduction, measured by a four-point or greater decrease in peak pruritus numerical rating scale, was 22.5% (Q4W) and 24.5% (Q12W) versus 12.7% for placebo. All key secondary endpoints in COAST 1 reached statistical significance. COAST 2 showed a similar pattern, with vIGA-AD 0/1 rates of 25.3% (Q4W) and 25.7% (Q12W) versus 14.8% for placebo. EASI-75 and itch endpoints reached nominal significance, though one secondary endpoint — vIGA-AD 0/1 with barely perceptible erythema — did not achieve statistical significance. The distinction between the two monotherapy trials is worth noting: COAST 2’s higher placebo response rate narrowed the treatment delta, a common challenge in atopic dermatitis trials with geographically diverse enrollment. SHORE, the combination study, produced the highest absolute response rates. vIGA-AD 0/1 was achieved by 28.7% (Q4W) and 32.3% (Q12W) of patients versus 16.8% on placebo plus topical therapy alone. EASI-75 reached 48.1% and 46.8% in the active arms versus 32.3% for placebo. All primary and key secondary endpoints were statistically significant. Across all three trials, Sanofi reported that efficacy was progressively increasing at Week 24 with no evidence of plateau, suggesting that longer treatment durations may yield higher response rates — a pattern that will be tested in the ongoing ESTUARY extension study. The safety profile was consistent with earlier-phase data. The most common adverse events across COAST 1, COAST 2, and SHORE were nasopharyngitis, atopic dermatitis flares, and upper respiratory tract infections, occurring at rates generally comparable to or lower than placebo. Malignancy rates were below 1% and similar between active and placebo groups. No severe injection site reactions or serious gastrointestinal ulceration events were reported. Sanofi disclosed a second case of Kaposi’s sarcoma in the amlitelimab development program, identified in the still-blinded ESTUARY Phase III extension study. Both Kaposi’s sarcoma cases occurred in patients with known risk factors, and both patients discontinued treatment and entered recovery. Out of an estimated 3,778 patients exposed to amlitelimab across all indications, no additional cases have been identified. The signal remains numerically small but warrants monitoring given the immunomodulatory mechanism. Sanofi stated that it “believes that amlitelimab continues to have the potential to be a meaningful and convenient option for patients with AD”. Amlitelimab is a fully human, non-T cell depleting monoclonal antibody that blocks OX40 ligand, a costimulatory molecule involved in the activation and survival of effector T cells. By targeting this upstream pathway, the drug aims to modulate pathogenic immune responses without the broad immunosuppression associated with JAK inhibitors or the cytokine-specific blockade of IL-4/IL-13 antibodies. The non-depleting design distinguishes it from therapies that reduce T cell populations, potentially offering a different safety-efficacy tradeoff. The atopic dermatitis treatment landscape in 2026 includes six approved systemic therapies for moderate-to-severe disease: dupilumab and tralokinumab (both anti-IL-4/IL-13 pathway), lebrikizumab (anti-IL-13), nemolizumab (anti-IL-31 receptor), and the oral JAK1 inhibitors abrocitinib and upadacitinib. All approved injectable biologics require dosing every two to four weeks. Amlitelimab’s Q12W regimen — approximately four injections per year — would represent a substantial reduction in treatment burden if the dosing schedule is maintained in regulatory filings. Cross-trial comparisons are limited by differences in study populations, placebo rates, and endpoint definitions, but the absolute vIGA-AD 0/1 and EASI-75 rates observed in the COAST and SHORE trials are numerically lower than those reported for dupilumab and upadacitinib in their respective pivotal programs. Whether the dosing convenience and mechanistic novelty offset the apparent efficacy gap will be a central question for regulators, payers, and prescribers. Rocatinlimab, developed by Amgen, targets the OX40 receptor rather than the ligand and is also in Phase III development for atopic dermatitis. The two drugs represent competing approaches to the same pathway, and their relative clinical profiles will become clearer as more data emerge. A 2024 review in the Journal of Dermatology and Therapy examined both molecules, noting that while they share a pathway target, their binding sites and downstream effects may differ. Results from ESTUARY, evaluating Q12W maintenance dosing and longer-term safety, are anticipated in the second half of 2026. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Clinical ResultPhase 3Immunotherapy

06 Mar 2026

·www.fiercepharma.com

Fierce Pharma Asia—Kyowa ends OX40 program; Sanofi licenses first-in-class drug; BioNTech advances Duality ADC

Kyowa Kirin's ill-fated OX40 autoimmune program, Sanofi and Sino Biopham's first-in-class licensing deal, and BioNTech and DualityBio's B7-H3 update made our news this week. Kyowa Kirin has decided to discontinue all clinical development of its OX40 drug after two new cancer cases emerged. Sanofi is committing up to $1.5 billion for global rights to Sino Biopharm's first-in-class JAK/ROCK inhibitor, which has potential in graft-versus-host disease. With strong early-stage data in prostate cancer, BioNTech is moving a DualityBio-licensed B7-H3 antibody-drug conjugate into phase 3. And more.1. New cancer cases prompt Kyowa to discontinue late-stage autoimmune disease programKyowa Kirin has decided to discontinue all clinical development of its anti-OX40 drug about a month after Amgen exited a partnership around the candidate, rocatinlimab. Two new cases of Kaposi’s sarcoma—one confirmed and one suspected—were reported on top of a previous case, drawing a “potential mechanistic link to OX40 pathway modulation,” according to the company.2. Sanofi strikes $1.5B global licensing deal for Sino Biopharm's first-in-class JAK/ROCK assetSanofi will pay $135 million upfront to obtain global rights to Sino Biopharm’s first-in-class JAK/ROCK inhibitor rovadicitinib, which was just approved in China in myelofibrosis. The drug’s “core value,” according to the seller, is in its potential in chronic graft-versus-host disease. The deal includes up to $1.395 billion in potential milestones. 3. BioNTech advances DualityBio ADC into phase 3 with half the patients of Merck-Daiichi rivalBioNTech’s DualityBio-partnered B7-H3 antibody-drug conjugate showed median radiographic progression-free survival of 11.3 months among heavily pretreated patients with metastatic castration-resistant prostate cancer, including some who had failed on Novartis’ Pluvicto. BioNTech is moving the drug, BNT324, into a phase 3 that’s half the size of a competing program from Merck & Co. and Daiichi Sankyo.4. Pfizer's oncology R&D strategy: Jeff Legos on speed, breadth and novel combinationsWith 3SBio’s PD-1xVEGF bispecific, partner Pfizer is aiming to beat the competition based on breadth of research, speed and novel combinations, the pharma’s oncology chief said. In less than a year since the agreement, Pfizer will have started 12 clinical trials of the drug, Pfizer’s Jeff Legos, Ph.D., told Fierce. Pfizer’s first phase 3 trials look similar to its competitors’, but the company is evaluating new combinations, including with its ADCs, he added.5. UCB enters TCE space with $1.1B deal for Chinese biotech's autoimmune candidateUCB is paying $80 million upfront for rights to a CD19xCD3 T-cell engager made by Antengene. The drug is slated to enter phase 1 testing in China and Australia by the end of March. Antengene is responsible for completing first-in-human studies before UCB takes over. The Chinese biotech is eligible to receive up to $1.1 billion in milestone payments.6. Roche pumps $480M into South Korea biopharma industry to establish global trial 'ecosystem'Roche signed a memorandum of understanding with the South Korean government for the Swiss pharma to spend about $484 million in South Korea’s biopharma industry. The partnership will strengthen the country’s competitiveness “by establishing an ecosystem for global clinical trials and enhancing R&D capabilities for innovative medicines,” a Roche spokesperson said.Other News of Note:7. Padcev-Keytruda combo aces another bladder cancer trial as MIBC landscape becomes more complex8. Ono's Deciphera drops early-stage solid tumor drug for strategic reasons9. Merck KGaA drops pipeline assets from SpringWorks buyout, Hengrui licensing deal10. BioDuro enters Taiwan joint venture, adding commercial API plant to production network11. TCE biotech Candid scores Nasdaq listing via reverse merger with rare-disease-focused Rallybio12. Earendil pens $885M pact to use WuXi XDC's linker tech for next-gen ADCs13. GLP-1 player QL Biopharm raises $73M in series C (Fundraising tracker)14. Daiichi Sankyo pens pact with Germany's Gaia to sell digital therapeutic for high cholesterol

Phase 3License out/inPhase 1ADC

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Indication	Highest Phase	Country/Location	Organization	Date
prurigo nodularis	Phase 3	United States	Amgen, Inc.	08 Jul 2024
Moderate Atopic Dermatitis	Phase 3	United States	Amgen, Inc.	31 May 2022
Moderate Atopic Dermatitis	Phase 3	China	Amgen, Inc.	31 May 2022
Moderate Atopic Dermatitis	Phase 3	Japan	Amgen, Inc.	31 May 2022
Moderate Atopic Dermatitis	Phase 3	Argentina	Amgen, Inc.	31 May 2022
Moderate Atopic Dermatitis	Phase 3	Brazil	Amgen, Inc.	31 May 2022
Moderate Atopic Dermatitis	Phase 3	Canada	Amgen, Inc.	31 May 2022
Moderate Atopic Dermatitis	Phase 3	Croatia	Amgen, Inc.	31 May 2022
Moderate Atopic Dermatitis	Phase 3	Czechia	Amgen, Inc.	31 May 2022
Moderate Atopic Dermatitis	Phase 3	Germany	Amgen, Inc.	31 May 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05398445 (ROCKET-IGNITE, Company_Website) Manual	Phase 3	Dermatitis, Atopic	769	Rocatinlimab higher dose	pfxvnxsnwl(betxdgjlmv) = xknlzyxzrr krauayyyxm (rsebqdplro ) Met View more	Positive	08 Mar 2025
				Rocatinlimab lower dose	pfxvnxsnwl(betxdgjlmv) = yezjqqylug krauayyyxm (rsebqdplro ) Met View more
NCT05724199 (ROCKET-SHUTTLE, Company_Website) Manual	Phase 3	Severe Atopic Dermatitis	746	Rocatinlimab higher dose + TCS/TCI	wkpubqveuc(lhzsbbjoip) = zcmmnsepne ycqrdxtuww (lkvfzyawzj ) Met View more	Positive	08 Mar 2025
				Rocatinlimab lower dose + TCS/TCI	wkpubqveuc(lhzsbbjoip) = mjcfjzoook ycqrdxtuww (lkvfzyawzj ) Met View more
NCT05651711 (ROCKET HORIZON, Corporate Publications) Manual	Phase 3	Dermatitis, Atopic	726	Rocatinlimab	ndmlbprxhj(cdqosawlrs) = nqdcwlkbsl cttcyzulct (qhvdgxkujk ) Met View more	Positive	25 Sep 2024
				Placebo	ndmlbprxhj(cdqosawlrs) = kskyqbcfcc cttcyzulct (qhvdgxkujk ) Met View more
NCT05651711 (ROCKET HORIZON, Company_Website) Manual	Phase 3	Severe Atopic Dermatitis	726	Rocatinlimab	etzcennooy(vfwumnpxap) = nvaslezhyq brdsrvaoyc (vozzlnkfzc ) Met View more	Positive	25 Sep 2024
				Placebo	etzcennooy(vfwumnpxap) = txyhjgjejh brdsrvaoyc (vozzlnkfzc ) Met View more
NCT03703102 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	274	KHK4083 (KHK4083 150 mg SC Q4W)	neawgvakjo(agxxkdfsvr) = shubjhkswr smyzejjpxd (yzudoucygq, kmnknwxmfn - xreotckdqo) View more	-	09 Jun 2022
				KHK4083 (KHK4083 600 mg SC Q4W)	neawgvakjo(agxxkdfsvr) = zqkabgqzag smyzejjpxd (yzudoucygq, fizdxtvpcr - shnnumjjcu) View more
NCT02647866 (CTgov)	Phase 2	Abdominal Pain \| Colitis, Ulcerative	66	KHK4083 (KHK4083 Cohort 1)	mafjccphch = heguqvjhed kkiuiubrsv (gzgilzcbkc, azoomfmzou - iemeiajwth) View more	-	05 Mar 2020
				KHK4083 (KHK4083 Cohort 2)	mafjccphch = dykbhhaslt kkiuiubrsv (gzgilzcbkc, npkeadbihp - yerygtdkdp) View more

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