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 unwanted 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 104 weeks, or 2 years. For participants in the United States, the treatment period may last up to 260 weeks, or 5 years
* There will be a follow-up safety period that lasts up to 24 weeks.
* Globally, participants will have up to 27 study visits during the treatment period. In the US, participants will have up to 66 study visits.
* Globally, the total study duration for participants will be up to 128 weeks. In the US, the total study duration will be up to 284 weeks .

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)

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 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

01 Jul 2025·CPT-Pharmacometrics & Systems Pharmacology

An Integrative Mechanistic Model of Type 1 IFN‐Mediated Inflammation in Systemic Lupus Erythematosus

Article

Author: Volkova, Alina ; Tettamanti, Florencia ; Ugolkov, Yaroslav ; Kimko, Holly ; Sokolov, Victor ; Tang, Weifeng ; Peskov, Kirill ; Verma, Meghna

ABSTRACT:

Type I interferon (IFN1) pathway–targeting therapies represent a highly promising class of remedies for the treatment of systemic lupus erythematosus. However, the overall clinical benefit of these compounds is afflicted by marked variability. In this study, we developed a quantitative systems pharmacology model of type I IFN‐mediated inflammation and applied it for an indirect comparison of anifrolumab, sifalimumab, daxdilimab, and litifilimab pharmacodynamic response, represented in the model by the change in IFN1 gene signature (IFNGS). The model consists of 20 ordinary differential equations and 68 parameters, among which four systemic parameters (including one random effect) were estimated using patient‐level data from Phase IIb anifrolumab clinical trial. Within‐target and within‐pathway validation was performed using study‐level pharmacokinetics, IFNα, and/or IFNGS data from five anifrolumab, four sifalimumab, one daxdilimab, and one litifilimab trials. The model successfully captured overall trends in IFNGS at clinically relevant doses of these compounds and discriminated IFNGS response between patients with low (< 2.75) and high (≥ 2.75) baseline IFNGS. Overprediction of treatment benefit was observed for the low range of anifrolumab doses (100–150 mg every 4 weeks). In contrast, IFNGS response under 150 mg of daxdilimab was underpredicted, despite the accurate description of plasmacytoid dendritic cells and IFNα biomarkers. Results of the global sensitivity analysis revealed baseline IFNGS, IFNα, and IFNα fraction as key factors affecting treatment benefit the most. In terms of maximum IFNGS reduction, anifrolumab showed superior potential compared to sifalimumab, daxdilimab, and litifilimab (ΔIFNGS~25%), which was further enhanced in patients with high baseline IFNGS or IFNα (ΔIFNGS~50%–60%).

News (Medical) associated with Litifilimab

01 Apr 2026

·www.biospace.com

Biopharma M&A Heats Up, Rare Diseases Win Three Approvals, Wave Crashes

Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart Biogen, Eli Lilly and Merck spent more than $20 billion in the past week to swallow biotechs with approved products or promising drug candidates—representing three of this year’s four biggest takeovers. First, Merck picked up Terns Pharmaceuticals and its mid-stage leukemia drug for $6.7 billion; for the record, BioSpace called this one back in December. Then, on Tuesday, Lilly and Biogen struck, acquiring Centessa Pharmaceuticals and Apellis Pharmaceuticals respectively. Those big-ticket deals aren’t the only recent transactions, however. Others include Novartis’ up to $2 billion pick up of Excellergy and Gilead’s $2.1 billion purchase of Ouro Medicines. Meanwhile, Kevin Tang—the newly minted CEO of Aurinia Pharmaceuticals—again has his sights set on Kezar Life Sciences , which he previously targeted in 2024. This time, biopharma’s “clean-up” man is offering $50 million for the chronic disease–focused biotech. We’ve spent a lot of time this past year writing about challenges facing rare disease drug developers, but this week, we saw some wins as the FDA approved three new therapies. Last week saw nods for Denali Therapeutics’ Avlayah, the first treatment for Hunter syndrome to target the disease’s neurological complications, and Rocket Pharmaceuticals’ Kresladi for leukocyte adhesion deficiency-I. And it’s been a big week for Biogen, which besides moving on Apellis, won approval of a high-dose formulation of spinal muscular atrophy drug Spinraza and scored a Phase 2 win for lupus candidate litifilimab in cutaneous lupus erythematosus. On the weight loss front, Wave Life Sciences ’ stock was cut in half after its obesity candidate WVE-007 failed to impress investors in a Phase 1 trial. And all eyes are trained on the FDA, which is expected to render a verdict on Lilly’s oral obesity drug orforglipron by April 10. And don’t forget to check out—or sign up for —BioPharm Executive, where we take a deep dive into delayed pharmaceutical launches in Europe and how AI is shaping the biotech IPO landscape.

Phase 1AcquisitionDrug Approval

31 Mar 2026

·www.biopharmadive.com

Biogen, with $5.6B Apellis buy, builds out immunology offerings

Biogen has agreed to spend at least $5.6 billion to diversify its lineup of immune system-regulating drugs through an acquisition of fellow Massachusetts-based biotechnology company Apellis Pharmaceuticals.The deal, announced Tuesday, has Biogen paying $41 in cash for every outstanding share of Apellis, reflecting a 140% premium to the latters closing share price Monday. Apellis investors will also receive nontransferable contingent value rights, or CVRs, that could be worth an additional $4 per share. The transaction has been approved by the boards of directors of both companies.Apellis research focuses on C3, a key protein involved in the complement part of the immune system, which acts as the bodys first line of defense against pathogens and damaged cells. When overactive, the complement system can attack healthy tissues and give rise to a vast range of diseases.Apellis is working to combat this with drugs specifically designed to inhibit C3.If completed, the buyout would give Biogen a handful of early-stage research projects as well as two products, Syfovre and Empaveli, that entered the market between 2021 and 2023. Syfovre treats geographic atrophy, an eye disease driven, at least in part, by a frenzied complement system that damages and destroys retinal cells. Empaveli, meanwhile, is used for a few rare disorders that affect the blood and kidneys.The opportunity to bring in two early launch commercial assets into the portfolio, from a growth perspective, is really important to us, Robin Kramer, Biogens chief financial officer, said in an interview.Paul Matteis, an analyst at the investment bank Stifel, argues that the deal is surprising, yet also makes strategic sense when considering Biogens interest in rare kidney diseases and non-neurology specialty drug markets. Two of the companys most closely watched research programs are litifilimab and felzartamab, which, respectively, are in late-stage testing for various kinds of lupus and uncommon kidney illnesses.That said, our biggest question here is around the value paid ... and what one needs to believe in terms of revenue potential to make this deal look cheap, Matteis wrote in a note to clients Tuesday.The analyst explained that the consensus on Wall Street is that Apellis revenue will reach $1.5 billion in 2030. If that pans out, the deals upfront multiple is about 3.5 times revenue. Thats not crazy at allto Matteis, though hitting that mark may be ambitious as it requires annual Empaveli sales to exceed $600 million along with a durable uptick in the growth rate for Syfovre.Apellis was profitable for the first time last year, recording net income of $22 million on nearly $690 million in product revenue. Syfovre contributed $587 million to that total, a dip of about 4% from the year prior.Under CEO Christopher Viehbacher and a reshaped leadership team, Biogen has used dealmaking to grow the immunology and rare disease portions of a research pipeline that, historically, leaned heavily into neuroscience.To that end, Biogen had been mulling an acquisition of Apellis for more than a year,according to Kramer. It ultimately pulled the trigger for several reasons, including the immunology crossover between the two companies and the Apellis teams expertise in nephrology, which should be valuable as Biogen prepares to launch felzartamab.Where we landed, it's in consideration of that intrinsic value, Kramer said. Looking at other metrics, such as multiple of revenue, we believe we fall straight in the middle of the pack as it relates to the transaction price.Lisa Walter, an analyst at RBC Capital Markets who covers Apellis, wrote in a note to clients that her team views the deal as good for the company given its share price has fallen by about a third this year.Overall, we see synergy between kidney asset Empaveli and [Biogens] nephrology portfolio, and Syfovre could potentially perform better in the hands of a larger company, she wrote.Hitting the sales milestones to trigger the deals CVR might be challenging, Walter added, though a pre-filled syringe version of Syfovre could gain approval before too long and help lift the franchise.The CVR is structured so Apellis investors would receive $2 per share if Syfovre achieves $1.5 billion in annual global net sales in any calendar year between 2027 and 2030, plus an additional $2 per share if the drug reaches $2 billion in annual global net sales in any of these calendar years.If those thresholds arent met, investors could still take home $4 per share if Syfovre generates $2 billion in annual global net sales in 2031. '

AcquisitionImmunotherapyDrug Approval

30 Mar 2026

·www.biopharmadive.com

United rises on IPF results; Biogen scores positive lupus data and an approval

Today, a brief rundown of news from United Therapeutics and Biogen, as well as updates from Eli Lilly, Novo Nordisk and Aurinia Pharmaceuticals that you may have missed.Shares of United Therapeutics were up nearly 15% Monday morning on data from a late-stage clinical trial that assessed the companys already-marketed drug Tyvaso in patients with a rare lung condition known as idiopathic pulmonary fibrosis. Another, similar trial had previously hit its main goal. According to United, the newer results from a study titled TETON-1 were even better. After a year of treatment, patients given Tyvaso showed an absolute change in forced vital capacity of 130.1 mL. FVC is a key test for potential IPF treatments, as it measures lung health by quantifying how much air a patient can forcefully exhale after taking a deep breath. Tyvaso is currently used for a lung-related illness called pulmonary arterial hypertension. The data from TETON-1 should favorably shift the Tyvaso narrative away from the nuances of the competitive PAH market and towards the more green field blockbuster opportunity of IPF, according to Leerink Partners analyst Roanna Ruiz.Biogen on Monday said the Food and Drug Administration approved a higher-dose version of the companys spinal muscular atrophy drug Spinraza. The new regimen will be available in the coming weeks, according to Biogen, and allows for an accelerated loading phase. Two 50 milligram doses are administered 14 days apart, followed by 28 milligram maintenance dose injections every four months thereafter. The approval should keep Biogens SMA franchise durable and serve as a bridge until the companys next-generation medicine, salanersen, comes to market, wrote Jefferies analyst Andrew Tsai in a note to clients. Tsai added that his team expects the Spinraza franchise, which generated roughly $1.5 billion in sales last year, to remain resilient (or even grow) despite the SMA market possibly getting more crowded over the next couple years.The FDA has approved Novo Nordisks Awiqli as an adjunct treatment to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. The FDA based its decision on data from four studies that enrolled nearly 2,700 patients and tested weekly shots of Awiqli. According to Novo, this is the first onceweekly basal insulin option approved for adult Type 2 diabetes patients in the U.S., and thereby provides a new treatment solution that fits different patient routines and preferences. The Denmark-based drugmaker said it plans to launch Awiqli in its FlexTouch devices in the states in the second half of this year.In other Biogen news, the companys experimental drug litifilimab succeeded in a mid-stage study of patients with cutaneous lupus erythematosus, an autoimmune condition marked by skin inflammation, scaly rashes and oral sores. According to a Saturday announcement from Biogen, the first part of the AMETHYST trial met its main objective, with litifilimab demonstrating an 11.8% higher reduction in disease activity compared to a placebo after 16 weeks of treatment. The results were consistent with what researchers observed in LILAC, a separate CLE study. A targeted antibody drug, litifilimab is also being evaluated as a treatment for another kind of lupus known as SLE.Aurinia Pharmaceuticals has agreed to acquire Kezar Life Sciences, a San Francisco-area biotech developing small molecule drugs for cancer and conditions where the immune system mistakenly attacks the bodys own healthy cells. For each share of Kezars common stock, Aurinia has agreed to hand investors just shy of $7 in cash, plus one non-transferable contingent value right that floats potential payments if certain goals are hit. The deal, announced Monday, comes after Kezars board of directors conducted a strategic review and unanimously determined that Aurinias proposal is in the best interests of the biotech and its stockholders. Kezars most advanced drug, zetomipzomib, is being evaluated as a possible treatment for autoimmune hepatitis, SLE and a kidney illness caused by SLE. Aurinias CEO Kevin Tang previously made a bid as an activist shareholder to acquire Kezar in 2024.Eli Lillys Ebglyss kept moderate-to-severe eczema in check for up to four years in a late-stage clinical trial, the company disclosed Friday. The open-label extension study showed 80% of participants who were given a once-monthly maintenance injection of Ebglyss experienced a durable response without the need for topical corticosteroids. Three-quarters of participants achieved EASI90 a test that signals near-complete skin clearance while 78% reported significant itch relief. An antibody drug, Ebglyss works by inhibiting an immune system-regulating protein called IL-13. Sanofi and Regenerons Dupixent also targets IL-13 as well as the related protein IL-4. '

Clinical ResultDrug ApprovalAcquisition

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

Indication

Phase

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)	nzcphxqcdt(fpytejlppv) = qptvqeziar ygiejjjnqv (oayncffocb, 10.3) View more	-	15 May 2023
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	nzcphxqcdt(fpytejlppv) = aniiztbdbr ygiejjjnqv (oayncffocb, 8.7) View more
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	Phase 2	Systemic Lupus Erythematosus BDCA2	132	Litifilimab 450 mg	zrglkkiqps(ctnyehqldi): 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	nkuogthcmq(ucqvtnumme) = Litifilimab was associated with one case of herpes zoster infection qalimundus (bqtycbvipt ) 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	tdmsxfylhh(tovtspqlki) = jhjscomaxd eweckeylxm (olmbqpcnqr ) View more	Positive	01 Jun 2022
				Placebo	tdmsxfylhh(tovtspqlki) = zsdcjzlabo eweckeylxm (olmbqpcnqr ) View more
NCT02847598 (LILAC study, EULAR2022)	Phase 2	Lupus Erythematosus, Cutaneous BDCA2	-	BIIB059	yynhxtmbxu(avjduxivfm) = iclfzzysaw qrrsqpajuq (femdufhbti ) View more	Positive	01 Jun 2022
NCT02847598 (LILAC, ACR2020) Manual	Phase 2	Systemic Lupus Erythematosus	120	BIIB059	tjriytfmkh(fyhnyugcxj) = mlhyqfmdmw wodrjmrtig (duafrlmpkv, 1.2) View more	Positive	07 Nov 2020
				Placebo	tjriytfmkh(fyhnyugcxj) = jksdapokrb wodrjmrtig (duafrlmpkv, 1.3) View more
NCT02847598 (LILAC, EULAR2020)	Phase 2	Lupus Erythematosus, Cutaneous	132	BIIB059 50 mg	kipswwqkft(vxsnqergse) = 62 (62.6%) 80 (60.6%) eralakxvdp (slmkwcsniv ) View more	Positive	03 Jun 2020
				BIIB059 150 mg
NCT02847598 (Pubmed \| J Pharmacokinet Pharmacodyn)	Phase 2	Lupus Erythematosus, Cutaneous	264	BIIB059	wggknwlyzt(wafldfuizo) = lrkusdrpsg axlmlpfwjy (qxosbvwwdd ) View more	-	01 Jun 2020
NCT02106897 (Pubmed \| J Clin Invest) Manual	Phase 1	Eczema \| Systemic Lupus Erythematosus	54	BIIB059	cmktsuakjd(nsjychwqow) = sdlorcwwam zwknhldprc (foxozikvyq ) View more	Positive	01 Mar 2019
				Placebo	cmktsuakjd(nsjychwqow) = svjyuqlqdh zwknhldprc (foxozikvyq ) View more
NCT02106897 (EULAR2018)	Phase 1	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	pcrlaeppeu(qxsxplrcct) = devmvjtwfb pmwjaaqbly (zqibdflahy ) View more	-	13 Jun 2018
				BIIB059 20, 50 or 150 mg SC	vcprekjqff(cmkouwdrak) = tndsgvwncd wakunsxbkn (gwhiiydplz ) View more

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