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

29 Apr 2026·INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

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

Review

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

01 Dec 2025·Arthritis & Rheumatology

Pharmacodynamic Effects of Litifilimab in Lupus in a Randomized, Placebo‐Controlled Phase 2 Study: Rapid and Sustained Reductions in Type I Interferon‐Associated Gene Expression and Cytokines

Article

Author: Furie, Richard ; Franchimont, Nathalie ; Milliman, Eric ; Ferber, Kyle ; Werth, Victoria P. ; Barbey, Catherine ; Lahoud, Youmna ; Zoghbi, Jad ; Brown, Roland

Objective:

The pharmacodynamic effects of litifilimab on type I interferon (IFN) response and correlations with clinical outcomes were investigated in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).

Methods:

Participants from part A (SLE) or part B (CLE with or without SLE) of the randomized phase 2 LILAC trial who received litifilimab (at 50 mg, 150 mg, or 450 mg) or a placebo were included. IFN gene signature (IFNGS) scores were assessed from whole‐blood samples using a 22‐gene panel in 120 and 131 participants (parts A and B, respectively). IFNα and other IFN‐regulated cytokine concentrations were measured in serum in 112 and 131 participants (parts A and B, respectively).

Results:

Most participants were IFNGS‐high at baseline (79–91%), and no baseline IFNGS‐low participant results were reported. In IFNGS‐high participants, litifilimab induced rapid, significant (nominal P < 0.05), and sustained reductions in IFNGS scores and IFNα concentrations versus a placebo for litifilimab at 450 mg in part A and for litifilimab at 150 mg and 450 mg in part B. In part A, IFNα reductions with litifilimab were correlated with clinical response measures. In part B, dose‐response relationships for IFNGS score and IFNα concentration were observed, similar to those for disease activity measured with the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI‐A) score.

Conclusion:

Administration of litifilimab resulted in reductions in both IFNGS scores and IFNα concentrations, pharmacodynamic effects that correlated with clinical responses. These findings support the mechanism of action of litifilimab and its continued evaluation in larger studies of patients with SLE or CLE.image

News (Medical) associated with Litifilimab

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

09 Jul 2026

·www.prnewswire.com

Systemic Lupus Erythematosus Market at a Turning Point as 6 Late-Stage Emerging Therapies Set to Redefine Treatment Landscape | DelveInsight

Companies like Biogen and Royalty Pharma (Litifilimab), Biogen and UCB (Dapirolizumab pegol), Idorsia Pharmaceuticals and Viatris (Cenerimod), Novartis (Ianalumab, YTB3231), Kyowa Kirin (KK-4277), and others are advancing late, mid, and early-stage drugs, showing promise in the systemic lupus erythematosus treatment market. LAS VEGAS, July 9, 2026 /PRNewswire/ -- Systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease that can affect multiple organ systems, with disease severity and clinical manifestations varying considerably among patients. Despite significant advances in understanding its pathophysiology, SLE remains incurable, and current treatment strategies primarily focus on controlling disease activity, achieving remission or low disease activity, preventing irreversible organ damage, minimizing flares, and improving patients' long-term quality of life. The therapeutic landscape for SLE remains limited, with only two therapies currently approved by the US FDA specifically for the disease: BENLYSTA (belimumab) from GlaxoSmithKline and SAPHNELO (anifrolumab) from AstraZeneca. Conventional treatment continues to rely on nonsteroidal anti-inflammatory drugs (NSAIDs), antimalarial agents, glucocorticoids, immunosuppressants, and other supportive therapies. While glucocorticoids remain a cornerstone of disease management, their well-documented long-term toxicities have intensified efforts to reduce steroid exposure through treat-to-target strategies. The persistent need for multiple lines of therapy and the limitations associated with existing treatments highlight the substantial unmet need for safer and more effective disease-modifying options. Discover what is the future of the systemic lupus erythematosus (SLE) drugs market @ The SLE pipeline is robust and increasingly diverse, with several late-stage and emerging therapies targeting novel immune pathways. Prominent investigational candidates include obinutuzumab (Roche), ianalumab (Novartis), dapirolizumab pegol (Biogen/UCB), upadacitinib (AbbVie), deucravacitinib (Bristol Myers Squibb), litifilimab (Biogen and Royalty Pharma), and other innovative agents that have the potential to improve disease control while reducing treatment-related toxicity. Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that Oral small molecules such as cenerimod (S1P1 modulator), deucravacitinib (TYK2 inhibitor), and upadacitinib (JAK1 inhibitor) target multiple immune pathways in SLE, reflecting a shift toward oral multi-pathway immune modulation in treatment. In parallel, CAR T-cell therapies are emerging as a potentially transformative approach for patients with refractory SLE by enabling targeted B-cell depletion and immune system reprogramming that could deliver durable, treatment-free remission. Leading programs in this space include rapcabtagene autoleucel (YTB-323), zolacabtagene autoleucel, resecabtagene autoleucel (CABA-201), and obecabtagene autoleucel (obe-cel, AUCATZYL), signaling a potential shift from lifelong immunosuppression toward one-time disease-modifying interventions. As per Thakur, CD19-directed CAR-T therapies, including rapcabtagene autoleucel, zolacabtagene autoleucel, and resecabtagene autoleucel, show strong potential in SLE by inducing deep B-cell depletion and durable remission, though safety risks such as CRS and ICANS require intensive monitoring. Reflecting the growing innovation and expanding therapeutic opportunities in this space, DelveInsight estimates that the SLE market across the leading markets, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 3 billion in 2025 and is projected to grow at a CAGR of 10.4% through 2036. Below, we highlight 6 emerging late-stage therapies poised to reshape the future of the systemic lupus erythematosus treatment market. Biogen and Royalty Pharma's Litifilimab CLEC4C protein inhibitors Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody designed to target BDCA2 (Blood Dendritic Cell Antigen 2) and is being developed as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor primarily found on plasmacytoid dendritic cells (pDCs), a specialized immune cell population involved in the production of inflammatory mediators. By binding to BDCA2, litifilimab suppresses pDC activation, thereby reducing the release of type I interferons (IFN-I) along with other proinflammatory cytokines and chemokines implicated in SLE pathogenesis. Biogen is currently evaluating litifilimab in two global Phase III clinical studies, TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567), for patients with SLE, with topline results anticipated by the end of 2026. In October 2025, the company announced that patient enrollment had been completed for both Phase III trials and that the expected data readout timeline had been accelerated to the second half of 2026. Earlier, in February 2025, Biogen entered into a funding agreement with Royalty Pharma, under which it is eligible to receive up to USD 200 million in 2025 and an additional USD 50 million in 2026 to help support the ongoing development of the litifilimab program. Roche's Obinutuzumab (GAZYVA/GAZYVARO) TSLP inhibitor Obinutuzumab is a glycoengineered monoclonal antibody designed to target the CD20 protein expressed on the surface of lymphoma and leukemia cells. As a type II anti-CD20 antibody, it exhibits greater antibody-dependent cellular cytotoxicity and stronger direct cell-killing activity compared with conventional CD20 antibodies. After binding to CD20, obinutuzumab promotes B-cell destruction by engaging immune effector cells, directly triggering intracellular death-signaling pathways, and activating the complement cascade. In Europe, the therapy is marketed under the name GAZYVARO. In February 2026, Roche submitted regulatory applications in the United States and Europe seeking approval of obinutuzumab for the treatment of Systemic Lupus Erythematosus. Subsequently, in April 2026, Roche announced that the FDA had accepted its supplemental Biologics License Application (sBLA) for obinutuzumab in SLE. The filing is based on positive results from the Phase III ALLEGORY study, which showed a statistically significant and clinically meaningful improvement in the primary endpoint. The FDA is expected to issue a decision on the application by December 2026. Discover more about which pipeline drugs could transform systemic lupus erythematosus treatment @ Systemic Lupus Erythematosus Market Size Novartis' Ianalumab BAFF-R inhibitor, ADCC-mediated B-cell depletor Ianalumab, a novel monoclonal antibody developed by Novartis, targets the B-cell Activating Factor Receptor (BAFF-R). It is designed to inhibit BAFF-R signaling while simultaneously promoting B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC). The therapy is currently being evaluated in two Phase III clinical studies for systemic lupus erythematosus (SLE): NCT05639114 (SIRIUS-SLE 1) and NCT05624749 (SIRIUS-SLE 2). According to Novartis' 2026 interim financial report, topline results from the Phase III SIRIUS-SLE 1 and SIRIUS-SLE 2 trials are expected in 2027. Pending positive outcomes, the company plans to submit Ianalumab for regulatory approval in SLE in 2028. Johnson & Johnson's Nipocalimab (IMAAVY) FcRn blockade Nipocalimab is an investigational immunoselective therapy engineered to selectively bind with high affinity to the neonatal Fc receptor (FcRn), blocking its activity and lowering circulating pathogenic IgG antibodies while maintaining essential immune functions. The therapy is being evaluated across three major autoantibody-driven disease areas: rheumatologic disorders, rare autoantibody-mediated conditions, and maternal-fetal diseases, where inhibiting IgG interaction with FcRn in the placenta is expected to reduce the transfer of harmful maternal alloantibodies to the fetus. In March 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration granted Fast Track Designation (FTD) to nipocalimab for the treatment of Systemic Lupus Erythematosus. Explore systemic lupus erythematosus competitors Johnson & Johnson marketed products @ Systemic Lupus Erythematosus Marketed Drugs Idorsia Pharmaceuticals and Viatris' Cenerimod Sphingosine 1-phosphate receptor modulators Cenerimod is a highly selective Sphingosine-1-Phosphate Receptor 1 (S1P1) modulator administered as a once-daily oral tablet. Although the exact cause of systemic lupus erythematosus remains unclear, dysregulated T and B lymphocytes are recognized as central drivers of disease pathogenesis. By selectively targeting the S1P1 receptor, cenerimod is designed to modulate lymphocyte trafficking and reduce immune-mediated inflammation. The therapy is currently being evaluated in two Phase III clinical trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576), for the treatment of SLE. The US FDA has also granted Fast Track Designation (FTD) to cenerimod, underscoring its potential to address an unmet medical need in SLE. In February 2025, Idorsia Pharmaceuticals amended its collaboration agreement with Viatris for the development of cenerimod. Under the revised terms, Idorsia's contribution toward the drug's 2025 development costs was reduced by USD 100 million. In exchange, the company agreed to a USD 250 million reduction in future regulatory and commercial milestone payments while granting Viatris expanded territorial commercialization rights for cenerimod. AbbVie's RINVOQ (upadacitinib) JAK 1 inhibitor Upadacitinib (ABT-494) is a selective inhibitor of Janus kinase 1 (JAK1) that is approved for the treatment of several immune-mediated inflammatory diseases, including ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In addition to its approved indications, the therapy is currently under clinical investigation for potential use in alopecia areata, hidradenitis suppurativa (HS), systemic lupus erythematosus (SLE), Takayasu arteritis, and vitiligo. AbbVie's RINVOQ (upadacitinib) continues to be an interesting lupus asset after its Phase 2 SLEek study showed meaningful activity in moderate to severe systemic lupus erythematosus, with the 30 mg monotherapy arm meeting the primary endpoint and achieving steroid-sparing benefit versus placebo. Updated data presented in 2023 also showed durability through 48 weeks, with fewer flares, longer time to first flare, and sustained improvements in disease-activity measures such as SRI-4, BICLA, and LLDAS, while no new safety signals were reported. The key development story is that AbbVie advanced RINVOQ into Phase 3 lupus testing after the positive Phase 2 readout, but it did not move forward with the ABBV-599 combination because elsubrutinib did not add enough efficacy to justify development. Find out more about top SLE CAR-T pipeline assets @ Systemic Lupus Erythematosus Clinical Trials Source: Systemic Lupus Erythematosus Market Report Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including GlaxoSmithKline, AstraZeneca, Genentech (Roche), AbbVie, Bristol Myers Squibb, Novartis, MorphoSys, UCB Pharma, Biogen, Juno Therapeutics, Johnson & Johnson Innovative Medicine, Idorsia Pharmaceuticals, Viatris, Merck, and others. Related Reports Systemic Lupus Erythematosus Clinical Trial Analysis Complement 3 Glomerulopathy Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Therapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, and others. JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, and others. FcRn Inhibitors Market FcRn Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key FcRn inhibitors companies, including Immunovant, Viridian Therapeutics, argenx, and others. TSLP Inhibitors Market TSLP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key TSLP inhibitors companies, including Sanofi, Uniquity Bio, Upstream Bio, Keymed Biosciences, Belenos Bioscience, Biosion, Pfizer, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Phase 3Phase 2Clinical ResultImmunotherapyFast Track

100 Deals associated with Litifilimab

R&D Status

10 top R&D records.

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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

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Evaluation

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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)	whjvxmxlld(hhfwhjnfvh) = uduxgngbbf jmqmxxenle (dhzqqfrwue, 10.3) View more	-	15 May 2023
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	whjvxmxlld(hhfwhjnfvh) = ndjekrkdhx jmqmxxenle (dhzqqfrwue, 8.7) View more
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	Phase 2	Systemic Lupus Erythematosus BDCA2	132	Litifilimab 450 mg	prgwvtxnqu(mpupvjxmhs): 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	nosmrtthhv(uwctztdatr) = Litifilimab was associated with one case of herpes zoster infection ddjlczdppu (npcgiifhcg ) View more	Positive	28 Jul 2022
				Litifilimab 150 mg
NCT02847598 (LILAC study, EULAR2022)	Phase 2	Lupus Erythematosus, Cutaneous BDCA2	-	BIIB059	szdqnysinj(dnvyhsclmp) = eyqtembkvv ugsbhbevkf (qrkjazzypd ) View more	Positive	01 Jun 2022
NCT02847598 (LILAC, EULAR2022)	Phase 2	Systemic Lupus Erythematosus anti-nuclear antibodies \| anti-double-stranded DNA antibodies	-	BIIB059 450 mg	qtncfrsomm(fdqyedwwwm) = siywrtsxzc nurycjtsba (cwstcbehqv ) View more	Positive	01 Jun 2022
				Placebo	qtncfrsomm(fdqyedwwwm) = zuxjalryfa nurycjtsba (cwstcbehqv ) View more
NCT02847598 (LILAC, ACR2020) Manual	Phase 2	Systemic Lupus Erythematosus	120	BIIB059	pmvgvjxhik(mcpbvadotn) = jlapluktgl vakqsbkjdu (zkjdtphtjk, 1.2) View more	Positive	07 Nov 2020
				Placebo	pmvgvjxhik(mcpbvadotn) = qsijhcjqpn vakqsbkjdu (zkjdtphtjk, 1.3) View more
NCT02847598 (LILAC, EULAR2020)	Phase 2	Lupus Erythematosus, Cutaneous	132	BIIB059 50 mg	jzijxnqcvr(pddffkirzj) = 62 (62.6%) 80 (60.6%) aziosnepso (jofbkrqzbt ) View more	Positive	03 Jun 2020
				BIIB059 150 mg
NCT02847598 (Pubmed \| J Pharmacokinet Pharmacodyn)	Phase 2	Lupus Erythematosus, Cutaneous	264	BIIB059	mnonkyqzwb(pytzjhpamy) = vrpghpomru plmrldhsbb (bywdajdfki ) View more	-	01 Jun 2020
NCT02106897 (Pubmed \| J Clin Invest) Manual	Phase 1	Eczema \| Systemic Lupus Erythematosus	54	BIIB059	wfgiyseecd(ilbhknfxui) = sxhfnoqlat renknyofge (fjscqmclzs ) View more	Positive	01 Mar 2019
				Placebo	wfgiyseecd(ilbhknfxui) = rvzxgizxpz renknyofge (fjscqmclzs ) View more
NCT02106897 (EULAR2018)	Phase 1	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	ndjtbrnyqv(ojtkqyaknh) = jxzxmdcxos pbyxidjzta (ymgzyeltno ) View more	-	13 Jun 2018
				BIIB059 20, 50 or 150 mg SC	weuainxobg(hronzbqcxc) = qqqqpgvthj nkbxtrsrtn (liqvfhscma ) View more

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