A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants

In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab subcutaneously (SC), also known as under the skin.
In this study, researchers want to learn more about new ways of delivering litifilimab SC using either an autoinjector (AI) or an on-body injector (OBI):
Both devices are designed to deliver litifilimab in an automatic way, especially helping patients who may not be able to use their hands very well, or who may be afraid of needles. While the AI is handheld, the OBI device works by being placed on the skin and can help deliver the highest amount of litifilimab through a single injection. The main objective of this study is to learn how the body processes litifilimab after using the AI device or the OBI device, as compared to using the PFS method.
The main questions researchers want to answer are:
* What is the highest amount of litifilimab found in the blood after dosing? How much total litifilimab is found in the blood throughout the study? Researchers will also learn more about: Any medical problems the participants have during the study
* Any injection site pain or reactions the participants may have. Any skin reactions to the OBI device
* Any changes in the participants' overall health after receiving litifilimab.
This study will be done as follows:
* Participants will be screened to check if they can join the study. The screening period will be up to 4 weeks, after which selected participants will check into their study research center.
* Participants will be randomly assigned to be in Part 1 or Part 2 of the study:
* Part 1: Participants will receive SC injection(s) of litifilimab through either the AI device or through PFS.
* Part 2: Participants will receive SC injection(s) of litifilimab through the OBI device or through PFS.
* Participants will remain at their study research center for the first 8 days. After that, there will be a follow-up period for 17 weeks during which participants return to the center a total of 6 times.
Each participant will be in the study for about 22 weeks.

Start Date02 Jan 2025

Sponsor / Collaborator

Biogen, Inc.

NCT06044337

/ Enrolling by invitationPhase 3

A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.
The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.
The main objective of the study is to learn more about the long-term safety of litifilimab.
The main question researchers want to answer is:
* How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug.
Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).
Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab.
The study will be done as follows:
* The last visit of parent study 230LE301 will be the first visit of study 230LE305.
* All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug.
* Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time.

Start Date03 Oct 2023

Sponsor / Collaborator

Biogen, Inc.

NCT05531565

/ Active, not recruitingPhase 2/3

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).
The main questions researchers want to answer are:
* How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?
* How many participants have their skin disease activity go down by at least 70% as measured by CLASI?
Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.
The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:
* After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.
* Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.
* The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.
* During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.
* After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.
* The total study duration for participants will be up to 80 weeks.

Start Date13 Sep 2022

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Litifilimab

100 Translational Medicine associated with Litifilimab

100 Patents (Medical) associated with Litifilimab

Literatures (Medical) associated with Litifilimab

01 Sep 2026·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Litifilimab efficacy on skin outcomes in cutaneous lupus erythematosus in the Phase 2 LILAC study

Article

Author: Furie, Richard ; van Vollenhoven, Ronald F. ; Romero‐Diaz, Juanita ; Kalunian, Kenneth ; Merola, Joseph F. ; Li, Qianyun ; Werth, Victoria P. ; Barbey, Catherine ; Yang, Weihong

Abstract:

Background:

Cutaneous lupus erythematosus (CLE) has no approved targeted therapies. In Part B of the randomized, double‐blind, placebo‐controlled, Phase 2 LILAC study, litifilimab demonstrated a dose–response relationship for percentage change in Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI‐A) score from baseline to Week 16.

Objectives:

These post hoc analyses of Part B of the LILAC study aimed to assess the efficacy of litifilimab on additional skin‐specific outcomes.

Methods:

Adult participants with baseline CLASI‐A score ≥8 and histologically confirmed CLE, with/without systemic manifestations, received litifilimab 50 mg, 150 mg or 450 mg, or placebo subcutaneously every 4 weeks through Week 16. Analyses included CLASI‐20/50/70/90 responses (≥20%/50%/70%/90% decrease [improvement] from baseline in CLASI‐A score), 7‐point improvement from baseline in CLASI‐A score, subgroup analyses of percentage change in CLASI‐A scores by baseline characteristics and achievement of ‘clear’ (CLASI‐A scores of 0–1) or ‘almost clear’ (0–3) skin status. Shifts from baseline in skin condition were evaluated by the Physician's Global Assessment (PGA) of CLE and the Physician's Global Impression (PGI) of change in CLE.

Results:

Greater proportions of litifilimab‐treated participants achieved CLASI‐20/50/70/90 responses (3.8%–72.1%) than placebo‐treated participants (0%–43.8%) at Week 16, with significant differences observed from Week 4 for CLASI‐20/50. From Weeks 4 to 16, more litifilimab‐treated participants had ≥7‐point CLASI‐A score decreases from baseline (13.8%–43.9%) compared with placebo (10.5%–21.1%). At Week 16, compared with placebo, more litifilimab‐treated participants achieved ‘clear’ or ‘almost clear’ skin status; CLASI‐A score improvements for subgroups were numerically higher with litifilimab, more litifilimab‐treated participants shifted from ‘severe’ or ‘moderate’ to ‘almost clear’ skin status based on PGA of CLE, and more litifilimab‐treated participants were ‘much improved’ based on PGI results.

Conclusions:

These analyses provide additional evidence to support litifilimab efficacy in clearing skin disease activity, as demonstrated in the LILAC study.

29 Apr 2026·INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Genetic Polymorphisms in Systemic Lupus Erythematosus and Their Clinical Implications: A Narrative Review.

Review

Author: Johdi, Nor Adzimah ; Azizan, Elena Aisha ; Rajalingham, Sakthiswary ; Egan, Audrey Matilda ; Shaharir, Syahrul Sazliyana ; Mohd, Rozita ; Zailani, Mohamed Afiq Hidayat

Systemic lupus erythematosus (SLE) is a polygenic autoimmune disorder where genetic diversity drives significant clinical heterogeneity. This review summarizes the current understanding of the roles of genetic polymorphisms in immunological dysregulation, organ-specific manifestations and therapeutic response heterogeneity in individuals with SLE. The literature was obtained from PubMed, EBSCOhost, Web of Science and Scopus. The narrative review comprised 60 publications published within the last 12 years. The research consistently identifies the major histocompatibility complex (MHC) region as the most significant genetic risk factor for the onset of autoimmunity. Genetic variants in STAT4 and IRF5 exacerbate disease progression by facilitating chronic inflammation. These genetic factors are associated with various clinical outcomes, including renal and neuropsychiatric symptoms. Polymorphisms in HLA class II, TLR7 and FBN2 are notably linked to serious consequences, including lupus nephritis (LN). Progress in targeted therapy signifies a transition to personalized medicine with medications such as anifrolumab, litifilimab, iberdomide and Janus kinase (JAK) or Cyclin-Dependent Kinase (CDK) inhibitors, demonstrating potential for targeting pathways associated with the interferon gene signature and STAT4 polymorphisms. Notwithstanding the problems presented by the heterogeneity of SLE, the identification of risk variations is anticipated to enhance predictive and therapeutic biomarkers, hence facilitating more precise and individualized disease management.

01 Jan 2026·The Journal of clinical and aesthetic dermatology

What's New in Cutaneous Lupus Erythematosus: Guidelines, Biologics, and Beyond.

Review

Author: Childs, Beth A ; Merola, Joseph F

OBJECTIVE:

We aim to review current treatment strategies for cutaneous lupus erythematosus (CLE) and highlight emerging therapies, evolving outcome measures, and practical considerations that may inform future management of this clinically heterogeneous disease.

METHODS:

We conducted a narrative review of the literature using PubMed to identify relevant clinical trials, observational studies, and mechanistic investigations related to CLE treatment. Emphasis was placed on studies published within the past 15 years. Expert opinion from dermatology and rheumatology was incorporated to contextualize evolving therapies and their application in clinical practice.

RESULTS:

Current management of CLE follows a stepwise framework, with antimalarials and immunosuppressants forming the foundation of systemic therapy. However, many patients experience refractory disease, especially in chronic or hypertrophic subtypes. Advances in the understanding of CLE pathogenesis have led to the development of targeted biologics and small molecule agents that modulate Type I interferon signaling, B- and T-cell activation, and inflammatory cytokine pathways. Novel tools such as Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) and the Investigator Global Assessment for Cutaneous Lupus (CLA-IGA-R) are being validated to standardize disease assessment, while RNA tape sampling and real-world electronic health record (EHR)-based algorithms are enhancing research precision. Emerging therapies, such as belimumab, anifrolumab, litifilimab, deucravacitinib, and enpatoran, demonstrate promise in both clinical trials and real-world settings.

LIMITATIONS:

As a narrative review, this study is limited by the lack of systematic inclusion criteria and formal quality assessment of individual studies.

CONCLUSION:

Ongoing therapeutic innovation, guided by mechanistic insights and strengthened by the development of standardized outcome measures, is transforming the CLE landscape and advancing the goal of precision-based, durable disease control.

News (Medical) associated with Litifilimab

28 Aug 2026

·www.fiercepharma.com

Biogen enlists lupus patient advocate to share social media story of resilience

Biogen’s late-stage lupus candidates may not have crossed the FDA finish line yet, but the company has already hit the ground running with its patient advocacy work. A new social media tie-up featuring lupus patient advocate Naomi Rose highlights her journey navigating the chronic autoimmune disease cutaneous lupus erythematosus (CLE), emphasizing the importance of connecting with community in the disease space. “Lupus has taught me resilience,” she says in the 54-second video . “Some days I have hope and some days it is hard to have hope.” The video continues with clips of Rose living her day-to-day life; working out, setting up her camera to film and spending time with her son. As she discusses the power of social media content and building community, a montage of video content from her own social media plays, flashing through a barrage of meaningful moments that she’s posted online. “These are real people, with real experiences that can actually relate,” Rose says, referring to the community of lupus patients she’s found by sharing her experience on social media. “And it just makes me happy to connect and find community within that. That is what keeps me going.” The video ends with Biogen’s “making breakthroughs happen” tagline, but this time with “in lupus” added in a different font. “Behind every lupus diagnosis is a person, a story, and a community,” Biogen wrote in its Facebook caption for the video. On Instagram, the company uses a different caption introducing Rose’s journey of “resilience, hope, and finding strength through community," further inviting its audience to “hear how connection and shared understanding have shaped her journey.” Outside of her work as a patient advocate for lupus nonprofit organizations such as 50 Shades of Pain and We Are ILL , Rose works in influencer marketing herself as a brand partnerships coordinator for an Atlanta-based creator, according to her LinkedIn. She has also amassed a large following on her own social media pages , where she posts motherhood and travel content on her personal page, plus lupus advocacy content on her lupus-specific page , Lupus Living Diaries. Biogen has enlisted several patient advocates so far in the lupus space, who have shared their stories as the company continues to study its two lupus candidates. The drugmaker is working on what it says could be the “first lupus portfolio in the industry” and developing treatments for both systemic lupus erythematosus (SLE) and CLE. Earlier this year, Biogen’s litifilimab earned a breakthrough therapy designation in CLE from the FDA, adding more weight to what the company hopes to be the first advanced therapy specifically approved to treat the disease subtype. Litifilimab is currently in phase 3 trials for CLE and SLE, with a data readout in CLE expected in 2027. In SLE, Biogen’s litifilimab studies were specifically designed to enroll participants that accurately reflect the U.S. lupus patient population, as the disease disproportionately impacts young women, especially in communities of color. Biogen often spotlights patient advocates on its social media, with recent posts including a celebration of spinal muscular atrophy (SMA) awareness month and a series of patient and caregivers sharing their Alzheimer’s disease stories. Earlier this summer, the company launched a campaign highlighting the “patient journey of individuals who have grown up with SMA,” using images shot from a lower angle to redefine how people view those who use assistive devices, Biogen told Fierce at the time.

Phase 3Breakthrough Therapy

29 Jul 2026

·www.fiercebiotech.com

‘We have what we need to grow:’ Biogen CEO happy to ease off the M&A for a while

Biogen's business development team may have been busy in recent years, but CEO Christopher Viehbacher is easing off the acquisitions for a while. The company's ongoing attempts to expand beyond its legacy multiple sclerosis products and its blockbuster spinal muscular atrophy treatment Spinraza and into immunology, nephrology and ophthalmology have seen Biogen absorb the likes of Apellis Pharmaceuticals , Alcyone Therapeutics , HI-BIO and Reata Pharmaceuticals over the past three years. Only last month, Biogen brought anti-inflammatory biotech RayThera into the fold. But on a call with analysts to discuss the company’s second-quarter earnings on Wednesday, Viehbacher suggested he might slow the pace of M&A in the near term. “There's been a significant growth in the breadth of our portfolio,” the CEO said on the call. “That's exciting, but it also means that now we are shifting to not just growing the substrate of growth, but now executing on that growth story.” “We have what we need to grow near term,” he added. “I think we'll be less intentional about M&A and perhaps more opportunistic, but we'll certainly be intentional about early-stage development.” If opportunities do arise, they will likely involve assets between the development and IND stage, Viehbacher added. When it comes to drugs already in later-stage development, Biogen is expecting registrational data for its systemic lupus erythematosus drug litifilimab by end of this year, with a phase 3 readout in cutaneous lupus erythematosus to follow in 2027. Also pencilled in for next year are late-stage readouts for felzartamab for antibody-mediated rejection in kidney transplants, and zorevunersen in Dravet syndrome. “We believe these investments are building a durable innovation with the promise of delivering sustainable, long-term growth and value creation,” Biogen's Head of Development Priya Singhal, M.D., said on the call. The company also reaffirmed plans to take its Alzheimer’s treatment diranersen into late-stage studies on the back of phase 2 data earlier this month showing the tau-targeting candidate slowed cognitive decline across a suite of different clinical assessments. That same data dented Biogen's stock at the time, largely due to confusion surrounding the strong performance of the lowest dose. But Viehbacher told analysts on this morning's call that there is a “good chance” that diranersen makes it to the market because of its ability to move cognition. It won’t be the only candidate moving forward out of Biogen in Alzheimer’s, suggested the CEO. “If we're going to be in Alzheimer's, we are certainly looking to have a portfolio,” he said, noting that blood-brain barrier shuttles “would be the next generation of products to pursue.” But not every candidate in Biogen's pipeline is being rushed forward. Singhal said the company is “taking a pause” to consider its options for its elapsing-remitting multiple sclerosis (RRMS) therapy BIIB091. Biogen previously discontinued an arm of a phase 2 trial looking at a combination of BIIB091 with its own MS drug Vumerity. “We see that it could have compelling efficacy in RRMS, but we are looking at what is the appropriate next step because we see RRMS as a very crowded, competitive market,” Singhal explained. “We haven't actually made a decision to specifically advance it into an indication, so we're not there yet.”

Phase 2AcquisitionPhase 3

29 Jul 2026

·www.biospace.com

Biogen shifts M&A strategy as Apellis acquisition pushes revenue above analyst expectations

iStock, rawintanpin Biogen officially began reporting revenue from the $5.6 billion acquisition of Apellis in the second quarter, shaking up analysts’ consensus estimates and leading to a beat. Biogen is switching to a “less intentional” M&A approach after spending $6.6 billion this year so far to buy Apellis and RayThera . “I think we have what we need to grow near term,” CEO Chris Viehbacher said on the company’s second quarter earnings call Wednesday morning. “I think we’ll be less intentional about M&A and perhaps more opportunistic.” ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); With growth trending up, Viehbacher said the goal with any future dealmaking is to fill in a few gaps in the early-stage pipeline. “Ideally, we’d like to be bringing in assets between development candidate and IND [investigational new drug] stage,” he said. With the acquisition of Apellis and its two marketed therapies, Biogen now has eight high-pro on the market that are serving as current revenue drivers. Mergers & acquisitions Biogen Secures ‘Running Start’ in Kidney Disease With $5.6B Apellis Buy In addition to delivering two approved medicines to Biogen’s portfolio, the acquisition of Apellis Pharmaceuticals will support the future launch of the pharma’s own kidney disease asset, currently in multiple Phase 3 trials. March 31, 2026 · 4 min read · Annalee Armstrong Read more The company has been laying the groundwork to rebuild its pipeline under Viehbacher. Most prominent is the upcoming lupus portfolio, which is led by litifilimab. The CEO said that with two indications possible in cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE), the drug could target an $8 billion market. So far the industry is only reaching about $2-$3 billion of that market, according to the CEO. He likened lupus to multiple sclerosis, which holds about a $20 billion opportunity. Then in the 2030s, Biogen is looking to Alzheimer’s disease prospect diranersen—albeit cautiously given the difficult nature of the disease area—for growth. Within each of these three pillars, Viehbacher said there is the potential for opportunistic M&A. Confounding the analysts Meanwhile, Biogen’s recently acquired companies are beginning to play a meaningful role in growth. The company officially began reporting revenue from Apellis in the second quarter, shaking up analysts’ consensus estimates and leading to a beat. The company reported $2.74 billion for the period, compared to the consensus estimate of $2.46 billion, according to William Blair. “The outperformance was primarily driven by stronger-than-expected contributions from the acquired Apellis products following the earlier-than-anticipated May 14 transaction close,” Truist Securities wrote on Wednesday. Biogen had previously been expecting full-year revenue to fall by a mid-single digit percent this year but has revised that expectation to a mid-single digit percent increase. Driving this outlook is the performance of Apellis’ Empaveli and Syfovre, which combined for $127.8 million in the second quarter. This marks a 22% year-over-year increase for the products after the “Biogen machine” was able to get behind the marketing push, said Alisha Alaimo, president of Biogen’s North America operations. At the same time, expectations for the year’s earnings per share (EPS) fell 15% with Apellis in the mix, with Biogen now expecting non-GAAP diluted EPS of between $12-$13, BMO Capital Markets noted. This reflects an 85-cent dilution from the transaction. Biogen had previously expected a range of $14.25-$15.25. “Overall, we view the quarter as better than expected, but not one that materially changes the investment narrative,” Truist wrote. “The results provide incremental confidence in management’s near-term execution and highlight the strategic value of the Apellis acquisition as a bridge to future growth.” But Biogen will have to execute on the key pipeline programs to truly win over investors, since much of the success of the second quarter relied on an acquisition, the firm added. “We do not believe the beat meaningfully alters the key debates surrounding Biogen’s long-term earnings trajectory, particularly given that much of the upside was acquisition- and royalty-driven rather than indicative of a fundamental inflection in the underlying business. As a result, we expect investor focus to remain squarely on upcoming pipeline de-risking events,” Truist said. Key to investors will be upcoming Phase 3 readouts for litifilimab in SLE, which is expected in the fourth quarter, and felzartamab in antibody mediated rejection of organ transplant, with data expected in the first half of 2027. Earnings With growth curve trending up, Biogen looks to early-stage assets for ‘next generation’ Biogen’s growth was expected to stay flat through the 2030s. A key acquisition and busy late-stage pipeline have relieved the pressure and cleared the way for some early-stage bets, CEO Chris Viehbacher said Wednesday. April 29, 2026 · 3 min read · Annalee Armstrong Read more

AcquisitionPhase 3

100 Deals associated with Litifilimab

External Link

KEGG	Wiki	ATC	Drug Bank
D12232	-	-	-

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Lupus Erythematosus, Cutaneous	Phase 3	United States	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	China	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Japan	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Argentina	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Belgium	Biogen Idec Research Ltd.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Brazil	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Bulgaria	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Canada	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Chile	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Colombia	Biogen, Inc.	03 Oct 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02847598 (LILAC \| LILAC study, CTgov)	Phase 2	Lupus Erythematosus, Cutaneous \| Systemic Lupus Erythematosus \| Lupus Erythematosus, Discoid	264	Placebo (Part A: Placebo)	yckqsqlddp(uqdqfrrsfs) = asiifsmvsm agpzmdhnna (bixbclesig, 10.3) View more	-	15 May 2023
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	yckqsqlddp(uqdqfrrsfs) = xacqzlpbuy agpzmdhnna (bixbclesig, 8.7) View more
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	Phase 2	Systemic Lupus Erythematosus BDCA2	132	Litifilimab 450 mg	qgyubzpsoj(otfupcrumg): P-Value = 0.04 View more	Positive	08 Sep 2022
				Placebo
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	Phase 2	Lupus Erythematosus, Cutaneous	132	Litifilimab 50 mg	aatwhntvyp(olahvmjuns) = Litifilimab was associated with one case of herpes zoster infection omldnjzotl (mxxwivtfkj ) View more	Positive	28 Jul 2022
				Litifilimab 150 mg
NCT02847598 (LILAC, EULAR2022)	Phase 2	Systemic Lupus Erythematosus anti-nuclear antibodies \| anti-double-stranded DNA antibodies	-	BIIB059 450 mg	yjzpqoaevv(mmpggikxjj) = caajnfejds ycnxgqmxaq (oynqwugfhb ) View more	Positive	01 Jun 2022
				Placebo	yjzpqoaevv(mmpggikxjj) = kikhgkfngs ycnxgqmxaq (oynqwugfhb ) View more
NCT02847598 (LILAC study, EULAR2022)	Phase 2	Lupus Erythematosus, Cutaneous BDCA2	-	BIIB059	hlxteadnau(nqnmyqgrkd) = xbclmejpgz rmuyyekrek (cxhlxxheog ) View more	Positive	01 Jun 2022
NCT02847598 (LILAC, ACR2020) Manual	Phase 2	Systemic Lupus Erythematosus	120	BIIB059	qktbcuezih(ihuvsacklq) = vpvuckzotd ksxnxemjjo (guowttviog, 1.2) View more	Positive	07 Nov 2020
				Placebo	qktbcuezih(ihuvsacklq) = wwekssbncx ksxnxemjjo (guowttviog, 1.3) View more
NCT02847598 (LILAC, EULAR2020)	Phase 2	Lupus Erythematosus, Cutaneous	132	BIIB059 50 mg	nckksunefr(gwebzxlbib) = 62 (62.6%) 80 (60.6%) rjocdzydei (kufsdutnjj ) View more	Positive	03 Jun 2020
				BIIB059 150 mg
NCT02847598 (Pubmed \| J Pharmacokinet Pharmacodyn)	Phase 2	Lupus Erythematosus, Cutaneous	264	BIIB059	gfufffolww(xovqfkdkxd) = dskmmeegpz ighohpeugy (segywjvbdc ) View more	-	01 Jun 2020
NCT02106897 (Pubmed \| J Clin Invest) Manual	Phase 1	Eczema \| Systemic Lupus Erythematosus	54	BIIB059	rccmyeicmc(yuaamxzcff) = mwiiuzjlgf ogzeteuvto (rjevjnqmfb ) View more	Positive	01 Mar 2019
				Placebo	rccmyeicmc(yuaamxzcff) = wtsndedoch ogzeteuvto (rjevjnqmfb ) View more
NCT02106897 (EULAR2018)	Phase 1	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	jctmjhwltl(ttffihmcfy) = qtfeuzpapj ehkxqrynjn (qruvdtqepk ) View more	-	13 Jun 2018
				BIIB059 20, 50 or 150 mg SC	uuhehnhbuc(dgatjiwxef) = rwhmslctqn mpwsanihdo (fizmnfxhqj ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis