[Translation] A multicenter, randomized, dose-blinded, phase III long-term extension study to evaluate the sustained safety and efficacy of BIIB059 in adult subjects with active systemic lupus erythematosus

本研究为一项多中心、随机、平行组、剂量设盲、III 期 LTE 研究。将在已完成研究 230LE303 或研究 230LE304（在本研究方案中称为“III 期母研究”）的持续 52 周研究治疗的受试者中开展本研究。

[Translation]

This study is a multicenter, randomized, parallel-group, dose-blinded, Phase III LTE study that will be conducted in subjects who have completed 52 weeks of study treatment in Study 230LE303 or Study 230LE304 (referred to as the “Phase III Parent Study” in this study protocol).

Start Date22 Apr 2024

Sponsor / Collaborator

Biogen Idec Research Ltd.

[+2]

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

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.
The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with systemic lupus erythematosus (SLE); to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.

Start Date03 Oct 2023

Sponsor / Collaborator

Biogen, Inc.

NCT05531565 / 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)

The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

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 May 2024·Current opinion in rheumatology

Emerging biologic therapies for systemic lupus erythematosus

Review

Author: Kato, Hiroshi ; Kahlenberg, J. Michelle

Purpose of review:

The approval of belimumab and anifrolumab has expanded the scope of treatment for systemic lupus erythematosus (SLE) patients. However, many patients remain refractory to currently available therapies and suffer from drug toxicities. This review will discuss approved and target-specific therapeutics in development that bring hope for better SLE treatments.

Recent findings:

Since the last review on this subject in the journal, the FDA has approved anifrolumab and belimumab for SLE and lupus nephritis (LN), respectively. A fully humanized anti-CD20, obinutuzumab, met the primary end point in a phase II trial in LN. A Tyk2 inhibitor, deucravacitinib, and an antibody targeting plasmacytoid dendritic cells, litifilimab, met the primary end point in phase II trials in SLE and cutaneous lupus erythematosus (CLE). Ustekinumab and baricitinib met the primary end point in phase II but not in phase III trials.

Summary:

While many drug candidates which met the end points in phase II trials have failed phase III trials, the number of target-specific therapies for SLE has continued to expand.

01 Jan 2024·Immunotherapy

The development of litifilimab (BIIB 059) for cutaneous and systemic lupus erythematosus

Review

Author: Furie, Richard ; Cho, Young Min

This review describes the litifilimab (BIIB 059) development program to date for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Plasmacytoid dendritic cells (pDCs), major producers of type I interferons (IFN-I), play a key role in SLE pathogenesis. Litifilimab, a humanized monoclonal antibody, binds to BDCA2, a protein uniquely expressed on pDCs. The consequence of BDCA2 ligation is the inhibition of IFN-I as well as IFN-III, cytokine and chemokine production. Phase I and II LILAC trial parts A and B achieved primary end points in SLE and CLE patients, confirming the importance of pDCs and IFN-I in SLE and CLE. Litifilimab is currently being evaluated in phase III trials in both SLE and CLE.

01 Jul 2023·American journal of clinical dermatology

Cutaneous Lupus Erythematosus: An Update on Pathogenesis and Future Therapeutic Directions.

Review

Author: Brägelmann, Christine ; Niebel, Dennis ; de Vos, Luka ; Fetter, Tanja ; Wenzel, Jörg

Lupus erythematosus comprises a spectrum of autoimmune diseases that may affect various organs (systemic lupus erythematosus [SLE]) or the skin only (cutaneous lupus erythematosus [CLE]). Typical combinations of clinical, histological and serological findings define clinical subtypes of CLE, yet there is high interindividual variation. Skin lesions arise in the course of triggers such as ultraviolet (UV) light exposure, smoking or drugs; keratinocytes, cytotoxic T cells and plasmacytoid dendritic cells (pDCs) establish a self-perpetuating interplay between the innate and adaptive immune system that is pivotal for the pathogenesis of CLE. Therefore, treatment relies on avoidance of triggers and UV protection, topical therapies (glucocorticosteroids, calcineurin inhibitors) and rather unspecific immunosuppressive or immunomodulatory drugs. Yet, the advent of licensed targeted therapies for SLE might also open new perspectives in the management of CLE. The heterogeneity of CLE might be attributable to individual variables and we speculate that the prevailing inflammatory signature defined by either T cells, B cells, pDCs, a strong lesional type I interferon (IFN) response, or combinations of the above might be suitable to predict therapeutic response to targeted treatment. Therefore, pretherapeutic histological assessment of the inflammatory infiltrate could stratify patients with refractory CLE for T-cell-directed therapies (e.g. dapirolizumab pegol), B-cell-directed therapies (e.g. belimumab), pDC-directed therapies (e.g. litifilimab) or IFN-directed therapies (e.g. anifrolumab). Moreover, Janus kinase (JAK) and spleen tyrosine kinase (SYK) inhibitors might broaden the therapeutic armamentarium in the near future. A close interdisciplinary exchange with rheumatologists and nephrologists is mandatory for optimal treatment of lupus patients to define the best therapeutic strategy.

News (Medical) associated with Litifilimab

24 Apr 2024

·www.fiercebiotech.com

To be better at neuroscience, Biogen will invest outside the therapeutic area

Biogen already signaled a foray into rare disease last year, where CEO Chris Viehbacher said the company has “tremendous commercial capability.” To be a better neuroscience company, Biogen is going to have to diversify—outside of the therapeutic area that has in recent years defined the company. “We always call ourselves a neuroscience company, but the reality of neuroscience is that this is a high-risk area,” CEO Chris Viehbacher said on the drug developer’s first-quarter earnings call Wednesday morning. And so Biogen will be focused on business development outside of the neuroscience arena, which in turn, will support the expensive, lengthy trials required of the beat. “While we remain committed to neuroscience, my personal view is that is not diversified enough for a company of our size,” the CEO said. Biogen already signaled a foray into rare disease last year, where Viehbacher said the company has “tremendous commercial capability.” Thanks to the slow buildout of Leqembi in Alzheimer’s disease, Biogen knows a thing or two about launching medicines in difficult areas where diagnosis is a challenge and hurdles with payers are rampant. Viehbacher also sees further potential for expansion in multiple sclerosis. “We are very well placed in neurology … but the reality is that we sit there with programs that are very difficult to predict, very expensive, very long-running. And when you actually look at the ability to do external deals, that field is also very narrow. There's just not that many people working in the CNS space,” Viehbacher said. “So we're by no means abandoning it. The fact that we go after these really tough diseases is really a source of pride within Biogen.” He continued: “But the reality is we need to have more predictable results out of R&D.” Biogen's industry peers have found plenty to buy in the space. Bristol Myers Squibb bought Karuna Therapeutics and its schizophrenia med KarXT for $14 billion while AbbVie picked up CNS-focused Cerevel Therapeutics for $8.7 billion, all at the end of 2023. Speaking of deals, Biogen is unlikely to take on a huge acquisition this year, given the company’s balance sheet, the CEO said. “If something really extraordinary came along, you’d look at it,” he said. Chief Financial Officer Michael McDonnell said the balance sheet is “in a very good spot” in terms of net debt for the first quarter. He says there’s about $4 billion to $5 billion to play with for an acquisition target. In 2025 or beyond, that number could grow. As for the pipeline, the executives had little to report with respect to concrete data, but Viehbacher promised more to come as three key readouts draw closer. A big one is Biogen’s anti-tau agent for Alzheimer’s disease called BIIB080, followed by phase 3 assets dapirolizumab pegol and litifilimab, both for systemic lupus erythematosus. Biogen has developed some tough go-no-go criteria to ensure those programs are only advanced if they prove promising, said Priya Singhal, M.D., head of development. “I think the next job is really now to build out the pipeline,” Viehbacher said. “We want to diversify our business a little bit more than we have in the past.”

AcquisitionPhase 3

28 Nov 2023

·www.fiercebiotech.com

Anaptys picks up rival to Biogen autoimmune asset from Centessa

Anaptys reiterated its cash runway in the statement to disclose the licensing of ANB101 Biogen has a new rival for the BDCA2 space. AnaptysBio is picking up a distant potential challenger to the big biotech’s late-phase lupus candidate, paying Centessa Pharmaceuticals $7 million upfront for rights to a preclinical prospect that is still months away from being submitted for testing in humans. BDCA2 is expressed exclusively on plasmacytoid dendritic cells. By binding to the antigen, antibodies can suppress the production of type I interferon and, in theory, improve outcomes in patients with diseases driven by the cytokine. Biogen reported midstage data on its drug candidate, litifilimab, in systemic lupus erythematosus last year and is running a phase 3 trial in the indication. Centessa picked up its BDCA2 program from Capella BioScience, one of the 10 biotechs it rolled up when it set up shop in 2021. Capella and Centessa have shared preclinical data on their lead BDCA2 candidate, CBS004, in systemic sclerosis, also known as scleroderma. Rather than take CBS004 into the clinic, Centessa, which is dissolving Capella and other U.K. businesses, has decided to offload the program to Anaptys for $7 million upfront. The fee includes a one-time cash payment of $3 million for manufactured and released GMP supply of CBS004, now renamed ANB101. A $10 million milestone payment, in either cash or shares, is tied to the start of the first phase 3 trial. In a statement, Anaptys CEO Daniel Faga outlined how ANB101 fits into the biotech’s strategy, explaining that it “specifically targets plasmacytoid dendritic cells, known to be key drivers of interferon secretion and antigen presentation” and complements its “immune cell modulators to drive differentiated clinical outcomes in systemic, heterogeneous autoimmune and inflammatory diseases.” Anaptys is adding ANB101 to its list of candidates that are set to join its two lead programs in the clinic. The biotech plans to file to study its CD122 antagonist ANB033 in humans in the first half of next year. An IND filing for ANB101 is slated for the second half of 2024. The candidates will sit alongside the PD-1 agonist rosnilimab and BTLA agonist ANB032 in Anaptys’ clinical-phase pipeline. Anaptys has started phase 2b trials of both candidates, in rheumatoid arthritis, ulcerative colitis and atopic dermatitis, in recent quarters, teeing up a series of data drops spanning from the end of next year through to the first half of 2026. Anaptys reiterated its cash runway in the statement to disclose the licensing of ANB101. The biotech still expects its money to fund operations through the end of 2026, giving it a shot at generating clinical data that drives up its share price before needing to seek additional funding.

Phase 3License out/inPhase 2

29 Aug 2023

·www.prnewswire.com

Cutaneous Lupus Erythematosus Market is Expected to Surge at a CAGR of 7.2% by 2032, Assesses DelveInsight

The dynamics of the cutaneous lupus erythematosus market are anticipated to change in the coming years owing to the expected launch of emerging therapies. The rising research and prevalence, along with the emergence of novel therapies, will fuel the cutaneous lupus erythematosus market during the forecast period of 2023–2032. LAS VEGAS, Aug. 29, 2023 /PRNewswire/ -- DelveInsight's Cutaneous Lupus Erythematosus Market Insights report includes a comprehensive understanding of current treatment practices, cutaneous lupus erythematosus emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan] and China. Key Takeaways from the Cutaneous Lupus Erythematosus Market Report As per DelveInsight analysis, the cutaneous lupus erythematosus market size in the 7MM and China was approximately USD 580 million in 2022 and it is expected to grow positively at a significant CAGR during the study period (2019–2032). As per the DelveInsight estimates, in 2022, the total diagnosed prevalent cases of cutaneous lupus erythematosus were around 1.4 million cases in the 7MM and China, which are expected to grow during the study period, i.e., 2019-2032. Globally, leading cutaneous lupus erythematosus companies such as Biogen, Horizon Therapeutics, Bristol-Myers Squibb, Gilead Sciences, Daiichi Sankyo, Inc., EMD Serono, Hoth Therapeutics, Zylo Therapeutics, Sanofi, Merck KGaA, Kyowa Kirin Co., Ltd., Priothera Ltd., Centessa Pharmaceuticals, Horizon Therapeutics, and others are developing novel cutaneous lupus erythematosus drugs that can be available in the cutaneous lupus erythematosus market in the coming years. Some key therapies for cutaneous lupus erythematosus treatment include Litifilimab, Daxdilimab, SOTYKTU (deucravacitinib), Edecesertib, DS-7011a, Enpatoran , and others. Discover which therapies are expected to grab the major cutaneous lupus erythematosus market share @ Cutaneous Lupus Erythematosus Market Report Cutaneous Lupus Erythematosus Overview Cutaneous lupus erythematosus (CLE) is a subtype of lupus erythematosus, an autoimmune disorder that primarily affects the skin. Cutaneous lupus erythematosus specifically targets the skin, causing a range of distinctive symptoms and manifestations. The exact cause of CLE is not fully understood, but it is believed to result from a complex interplay of genetic predisposition, environmental triggers, and immune system dysfunction. Cutaneous lupus erythematosus symptoms can vary widely and often depend on the specific subtype, which includes discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), and tumid lupus erythematosus (TLE). Common symptoms include skin rashes, lesions, and sensitivity to sunlight. The characteristic butterfly-shaped rash across the cheeks and nose, known as malar rash, is often associated with lupus. Diagnosing cutaneous lupus erythematosus involves a combination of clinical evaluation, medical history assessment, and laboratory tests. Dermatologists and rheumatologists may collaborate in the diagnostic process. Skin biopsies of affected areas can reveal specific histopathological features that help differentiate CLE from other skin conditions. Blood tests, such as antinuclear antibody (ANA) testing, can also assist in confirming the diagnosis and ruling out systemic involvement. Cutaneous Lupus Erythematosus Epidemiology Segmentation As per the DelveInsight estimates, in 2022, the total tumor prevalent cases of CLE by gender were around 347K and 1.1 million cases for males and females, respectively, in the 7MM and China, which are expected to grow during the study period, i.e., 2019─2032. The cutaneous lupus erythematosus market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM and China segmented into: Total Diagnosed Prevalent Cases Total Prevalent Cases of CLE by Gender Total Prevalent Cases of CLE by Type Total Treated Cases Total Prevalent Cases of CLE by Severity Cutaneous Lupus Erythematosus Treatment Market Cutaneous lupus erythematosus treatment is a nuanced process that takes into account the diverse clinical presentations and underlying immune mechanisms of the disorder. For patients with mild, localized forms of CLE, topical therapies like corticosteroid creams, calcineurin inhibitors, and retinoids can be beneficial in reducing inflammation and controlling symptoms. Antimalarial medications, such as hydroxychloroquine, are considered a cornerstone of CLE treatment due to their ability to modulate the immune response and mitigate skin manifestations. In cases of more extensive or persistent CLE, systemic treatments may be necessary. Immunosuppressive drugs like methotrexate, azathioprine, mycophenolate mofetil, and cyclosporine can help manage the immune dysfunction that triggers skin symptoms. Biologic agents, which target specific components of the immune system, are emerging as potential options for severe or treatment-resistant cases. However, the cutaneous lupus erythematosus treatment landscape is complex and evolving. Therapeutic choices are tailored to the individual's subtype, symptom severity, and overall health. Additionally, patient education on sun protection and skin care remains a crucial aspect of CLE management, as ultraviolet light can exacerbate symptoms. Multidisciplinary collaboration between dermatologists, rheumatologists, and other healthcare providers ensures a comprehensive approach to care, addressing not only the physical symptoms but also the psychological and emotional aspects of living with a chronic autoimmune condition like CLE. Regular monitoring and adjustment of treatment plans, along with ongoing research efforts, contribute to refining the strategies for managing cutaneous lupus erythematosus. To know more about cutaneous lupus erythematosus treatment, visit @ Cutaneous Lupus Erythematosus Treatment Drugs Key Cutaneous Lupus Erythematosus Therapies and Companies Litifilimab: Biogen Daxdilimab: Horizon Therapeutics SOTYKTU (deucravacitinib): Bristol-Myers Squibb Edecesertib: Gilead Sciences DS-7011a: Daiichi Sankyo, Inc. Enpatoran: EMD Serono Learn more about the FDA-approved drugs for cutaneous lupus erythematosus @ Drugs for Cutaneous Lupus Erythematosus Treatment Cutaneous Lupus Erythematosus Market Dynamics The cutaneous lupus erythematosus market dynamics have undergone a significant transformation in recent times. This relatively understudied facet of lupus, primarily affecting the skin, has gained recognition due to heightened awareness and improved diagnostic techniques. The growing prevalence of autoimmune disorders, including CLE, has prompted pharmaceutical companies to invest in research and development endeavors targeting innovative treatment approaches. Clinicians and patients alike are advocating for therapies that not only alleviate the visible symptoms of skin involvement but also address the underlying immune dysregulation. The advent of precision medicine has fueled the exploration of targeted interventions, such as monoclonal antibodies and Janus kinase (JAK) inhibitors, tailored to counteract specific immune pathways driving CLE. These advancements, although promising, come with challenges like high development costs and the need for comprehensive clinical trials to establish efficacy and safety profiles. Additionally, the cutaneous lupus erythematosus market dynamics are influenced by the demand for non-pharmacological interventions, such as photoprotective measures and lifestyle modifications, which form an integral part of holistic CLE management. Despite increased attention, the limited understanding of CLE's intricate pathophysiology remains a significant hurdle. The complexity of immune system dysregulation specific to skin involvement presents challenges in identifying suitable drug targets and developing precise interventions. Additionally, the lack of standardized diagnostic criteria for various CLE subtypes can delay accurate diagnosis and initiation of appropriate treatment. Limited awareness and knowledge among healthcare professionals regarding CLE's diverse manifestations can lead to misdiagnosis or underdiagnosis, affecting patient access to timely and proper care. This is exacerbated by the scarcity of dedicated treatment guidelines, leading to variations in therapeutic approaches. Moreover, as the cutaneous lupus erythematosus market moves towards personalized medicine, the challenge of developing treatments that can cater to the genetic and immunological diversity of CLE patients becomes evident. Scope of the Cutaneous Lupus Erythematosus Market Report Therapeutic Assessment: Cutaneous Lupus Erythematosus current marketed and emerging therapies Cutaneous Lupus Erythematosus Market Dynamics: Conjoint Analysis of Emerging Cutaneous Lupus Erythematosus Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Cutaneous Lupus Erythematosus Market Access and Reimbursement Discover more about cutaneous lupus erythematosus drugs in development @ Cutaneous Lupus Erythematosus Clinical Trials Table of Contents Related Reports Cutaneous Lupus Erythematosus Pipeline Cutaneous Lupus Erythematosus Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key cutaneous lupus erythematosus companies, including Hoth Therapeutics, Zylo Therapeutics, Sanofi, Gilead Sciences, Bristol-Myers Squibb, Merck KGaA, Kyowa Kirin Co., Ltd., Priothera Ltd., Centessa Pharmaceuticals, Horizon Therapeutics, among others. Cutaneous Lupus Erythematosus Epidemiology Cutaneous Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted cutaneous lupus erythematosus epidemiology in the 7MM. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key systemic lupus erythematosus companies, including GlaxoSmithKline, AstraZeneca, Eli Lilly and Company, Biogen, UCB Pharma, Biogen, Immupharma, Hoffmann-La Roche, Xencor, Idorsia Pharmaceuticals, Bristol-Myers Squibb (Celgene), Resolve Therapeutics, Genentech (Roche), Pfizer, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis 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 Thearapeutics, 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, among 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] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

100 Deals associated with Litifilimab

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Erythematosus, Cutaneous	Phase 3	US	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	CL	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	FR	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	ES	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	SE	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	CH	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Discoid	Phase 3	US	Biogen, Inc.	13 Sep 2022
Lupus Erythematosus, Discoid	Phase 3	JP	Biogen, Inc.	13 Sep 2022
Lupus Erythematosus, Discoid	Phase 3	AR	Biogen, Inc.	13 Sep 2022
Lupus Erythematosus, Discoid	Phase 3	BR	Biogen, Inc.	13 Sep 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02847598 (CTgov)	Phase 2	Lupus Erythematosus, Cutaneous \| Systemic Lupus Erythematosus	264	Placebo (Part A: Placebo)	luwhubhdnx(oxlpgollah) = mxacgrwhth jteyvpckot (pvxgipoajx, xmpqefxndz - qzfokinlar) View more	-	15 May 2023
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	luwhubhdnx(oxlpgollah) = pvmyaitmhq jteyvpckot (pvxgipoajx, gpotrxnjbo - qqrvudmnnx) View more
NCT02847598 (LILAC, Pubmed \| Br Dent J)	Phase 2	Systemic Lupus Erythematosus	132	Litifilimab 450 mg	jtqmstseow(cdivptlaoa): P-Value = 0.04 View more	Positive	08 Sep 2022
				Placebo
NCT02847598 (LILAC, Pubmed \| Br Dent J)	Phase 2	Lupus Erythematosus, Cutaneous	132	Litifilimab 50 mg	qsnihbnwcz(vgdcrlvdze) = Litifilimab was associated with one case of herpes zoster infection ypcpcevpeu (bpjxmzicjg ) View more	Positive	28 Jul 2022
				Litifilimab 150 mg
NCT02847598 (LILAC study, EULAR2022)	Phase 2	Lupus Erythematosus, Cutaneous BDCA2	-	BIIB059	zblrwqmlfa(jnvyheugru) = lvkeioobwp rwqthaasdw (asltovlhvr ) 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	mlvslcexcz(rpceedpetq) = ruknpcbkgk axmqexnuhi (zdefgkvjxb ) View more	Positive	01 Jun 2022
				Placebo	mlvslcexcz(rpceedpetq) = jzieiphrxs axmqexnuhi (zdefgkvjxb ) View more
NCT02847598 (LILAC, ACR2020) Manual	Phase 2	Systemic Lupus Erythematosus	120	BIIB059	ylvgpueklz(zphjldkmgf) = bbbjfbmbwt wnxnffwdoi (felqsjzmmd, 1.2) View more	Positive	07 Nov 2020
				Placebo	ylvgpueklz(zphjldkmgf) = stfouvnude wnxnffwdoi (felqsjzmmd, 1.3) View more
NCT02847598 (LILAC, ACR2020)	Phase 2	Systemic Lupus Erythematosus ANA \| anti-dsDNA antibodies	-	BIIB059 450 mg	izvnnsrtot(hnwipoqnli) = vzawxqalst efpjbhaxqp (cpynuvsnsw, 1.2)	Positive	07 Nov 2020
				Placebo	izvnnsrtot(hnwipoqnli) = izvyswzkzi efpjbhaxqp (cpynuvsnsw, 1.3)
LILAC (EULAR2020)	Phase 2	Lupus Erythematosus, Cutaneous	132	BIIB059 50 mg	zowyjaqtbz(ioboqvblrd) = 62 (62.6%) 80 (60.6%) taxqifhahg (utpgavwnsq ) View more	Positive	03 Jun 2020
				BIIB059 150 mg
NCT02847598 (Pubmed)	Phase 2	Systemic Lupus Erythematosus	264	BIIB059	jgbyjgexlg(dwwdgpfebl) = pptobhxtzl tayfqhhald (hfmcvmbmpt ) View more	-	01 Jun 2020
NCT02106897 (Pubmed \| J Clin Invest) Manual	Phase 1	Eczema \| Systemic Lupus Erythematosus	54	BIIB059	ixzpbnzlmr(fwrgsowcqz) = mgzozgtlry rlaurvhxyg (hbcunexpry ) View more	Positive	01 Mar 2019
				Placebo	ixzpbnzlmr(fwrgsowcqz) = lsiyytfexh rlaurvhxyg (hbcunexpry ) View more

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