litifilimab (BIIB059) / Biogen, Royalty - LARVOL DELTA

Biogen Announces Second Positive Phase 2 Litifilimab Trial in Cutaneous Lupus Erythematosus at 2026 American Academy of Dermatology Annual Meeting, Showing a Significant Reduction in Skin Disease Activity (Biogen Press Release) - "AMETHYST Part A met its primary endpoint with litifilimab demonstrating a statistically significant 11.8% higher reduction in disease activity in people living with CLE (95% confidence interval [CI]: 1.39, 22.27; p < 0.05) as measured by the Cutaneous Lupus Activity Investigators’ Global Assessment Revised (CLA-IGA-R) erythema score of 0-1 (clear/almost clear) at Week 16, compared to placebo (14.7% vs. 2.9%)...Litifilimab was associated with rapid and continued improvement in skin disease activity with separation from placebo observed as early as Week 4 (19.3% vs. 5.5%; Δ= 13.8; CI: 1.19, 26.46), as measured by Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity-50 (CLASI-50) response through Week 24 (40.8% vs. 21%; Δ= 19.8; CI: 1.46, 38.15)."

P2 data • Cutaneous Lupus Erythematosus

Efficacy and Safety of Litifilimab in Cutaneous Lupus Erythematosus (CLE): 24-week results of the Phase 2 Study, AMETHYST Part A (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • P2 data • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways (clinicaltrials.gov) - P1 | N=404 | Completed | Sponsor: Biogen | Active, not recruiting ➔ Completed

Trial completion

Therapeutic Approaches for Cutaneous Lupus Erythematosus: a Changing Landscape of Clinical Trials. (PubMed, J Inflamm Res) - "Existing SLE drugs such as belimumab and anifrolumab have shown potential promise as a treatment for CLE, and a Phase III CLE clinical trial for anifrolumab is ongoing. Other emerging therapies such as deucravacitinib, litifilimab, and enpatoran have been successful with skin-related endpoints in Phase II CLE trials...As CLASI has become an accepted primary endpoint for clinical trials, drug development is shifting to prioritize cutaneous outcomes and to use endpoints that measure skin-specific effects. This targeted approach represents a fundamental change that may ultimately increase FDA-approved therapies specifically for CLE and expand treatment options for patients with CLE."

Journal • Review • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

AMETHYST: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (clinicaltrials.gov) - P2/3 | N=450 | Recruiting | Sponsor: Biogen | N=217 ➔ 450

Enrollment change • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus

Biogen to Present New Late-Breaking Litifilimab Phase 2 AMETHYST Data in Cutaneous Lupus Erythematosus at 2026 American Academy of Dermatology Annual Meeting (Biogen Press Release) - "Additional presentations at AAD will provide new insights into measures used to assess the severity of CLE disease activity in both clinical trials and clinical practice...'The Phase 3 part of the study, which will further evaluate litifilimab in CLE, is on track and a data readout is expected in 2027.'"

Clinical data • Late-breaking abstract • Cutaneous Lupus Erythematosus

Litifilimab Improves Cutaneous Lupus Erythematosus Disease Activity: 24-Week CLASI-A Change from Baseline in AMETHYST Part A (EULAR 2026) - No abstract available

Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

230LE301: A 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 (clinicaltrialsregister.eu) - P2/3 | N=201 | Recruiting | Sponsor: Biogen Idec Research Limited

New P2/3 trial • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus

Litifilimab: Data readout from P3 TOPAZ-1 trial (NCT04895241) for SLE in H2 2026 (Biogen) - Q4 2025 Results: Data readout from P3 AMETHYST trial (NCT05531565) for active cutaneous lupus erythematosus in mid-2027

P3 data • Cutaneous Lupus Erythematosus • Immunology • Lupus • Systemic Lupus Erythematosus

What's New in Cutaneous Lupus Erythematosus: Guidelines, Biologics, and Beyond. (PubMed, J Clin Aesthet Dermatol) - "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."

Journal • Review • CNS Disorders • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Rheumatology • Systemic Lupus Erythematosus

TOPAZ-2: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=562 | Active, not recruiting | Sponsor: Biogen | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options (GlobeNewswire) - "The designation is intended to expedite the development and review of drugs for serious conditions, and is based on the totality of litifilimab data, including the results from the Phase 2 LILAC study...Biogen is continuing to evaluate the efficacy and safety of litifilimab in the AMETHYST Phase 3 study, with a data readout expected in 2027."

Breakthrough therapy • P3 data • Cutaneous Lupus Erythematosus

Litifilimab efficacy on skin outcomes in cutaneous lupus erythematosus in the Phase 2 LILAC study. (PubMed, J Eur Acad Dermatol Venereol) - "These analyses provide additional evidence to support litifilimab efficacy in clearing skin disease activity, as demonstrated in the LILAC study."

Clinical • Journal • P2 data • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammatory Arthritis • Lupus

A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways (clinicaltrials.gov) - P1 | N=404 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting

Enrollment closed

TOPAZ-2: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=562 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2026 ➔ Sep 2025

Enrollment closed • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

TOPAZ-1: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=548 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Today [Biogen] announced both litifilimab Phase 3 studies for systemic lupus erythematosus fully enrolled with expected data readout for both studies now accelerated to H2 2026 (Biogen Press Release)

Enrollment closed • P3 data • Systemic Lupus Erythematosus

Litifilimab: Data from P3 TOPAZ-2 trial (NCT04961567) for SLE in 2026 (Biogen) - Q3 2025 Results

P3 data • Cutaneous Lupus Erythematosus • Lupus • Systemic Lupus Erythematosus

LBL-047, A First-In-Class Anti-BDCA2/TACI Fusion Protein, Inhibits the Function of Both pDCs and B cells [WITHDRAWN] (ACR Convergence 2025) - "Litifilimab, an anti-BDCA2 antibody, has demonstrated promising preliminary efficacy and excellent safety profile in patients with cutaneous lupus erythematosus...Targeting this pathway, two TACI based recombinant fusion proteins, such as Povetacicept and Telitacicept, have shown clinical benefits and favorable safety profile in autoimmune disease trials... LBL-047 has shown dual immunosuppressive effects, inhibiting simultaneously the function of pDCs and B cells both in vitro and in vivo. In addition, it has demonstrated excellent PK and PD profile, coupled with good safety profile and tolerability in cynomolgus monkeys. Taken together, these findings support the clinical development of LBL-047 and highlight its promise as a therapeutic candidate for autoimmune diseases."

Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • CD34 • IFNA1 • IL6 • TNFA

All Subcomponents of the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI-A) are Relevant to Identify and Detect Changes in Skin Activity (EADV 2025) - P2 | "Introduction & Objectives: Part B of the Phase 2 LILAC study (NCT02847598) demonstrated the efficacy of litifilimab versus placebo, with a significant decrease in percent change from baseline in CLASI-A score at Week 16 in participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations.1 CLASI-A measures disease activity in CLE across several anatomical locations, based on five clinical subcomponents: erythema, scale/hypertrophy, mucous membrane lesions, recent hair loss (preceding 30 days), and non-scarring alopecia.2 This exploratory analysis examined the distribution of CLASI-A subcomponents by anatomical locations and the contribution of all five CLASI-A subcomponents in the total scoring change, and explored the association between sunlight-exposed body areas and severity of the symptom... No single subcomponent of the measure drives the CLASI-A score or the CLASI-A score changes. CLASI-A is able to identify skin..."

Alopecia • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammatory Arthritis • Lupus

Biogen Highlights Multiple Assets and Indications in Lupus (Biogen Press Release) - "The webcast will illustrate the science behind the portfolio and strategic opportunities to improve and expand treatment options for people with lupus. Specifically, it will feature the distinct mechanisms of action and compelling data supporting litifilimab and DZP, along with details of the Phase 3 designs and expected timing of data readouts."

Clinical • Systemic Lupus Erythematosus

A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways (clinicaltrials.gov) - P1 | N=404 | Recruiting | Sponsor: Biogen | N=236 ➔ 404 | Trial completion date: Oct 2025 ➔ Apr 2026 | Trial primary completion date: Oct 2025 ➔ Apr 2026

Enrollment change • Trial completion date • Trial primary completion date

Litifilimab: Data readout from P3 AMETHYST trial (NCT05531565) for active cutaneous lupus erythematosus in Q4 2026/Q1 2027 (Biogen) - Q2 2025 Results: Data readout from P3 TOPAZ-1 trial (NCT04895241) for SLE by end of 2026

P3 data • Cutaneous Lupus Erythematosus • Lupus • Systemic Lupus Erythematosus

[[Translated article]]RF - New Treatments in Cutaneous Lupus Erythematosus: Current and Future Perspectives. (PubMed, Actas Dermosifiliogr) - No abstract available

Journal • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Pharmacodynamic Effects of Litifilimab in Lupus in the LILAC Phase II Study: Rapid and Sustained Reductions in Type I Interferon-Associated Gene Expression and Cytokines. (PubMed, Arthritis Rheumatol) - "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."

Journal • P2 data • PK/PD data • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IFNA1