litifilimab (BIIB059) / Biogen, Royalty - LARVOL DELTA

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

Litifilimab: Data from P3 TOPAZ-2 trial (NCT04961567) for SLE in 2026 (Royalty Pharma) - Q1 2025 Results

P3 data • Systemic Lupus Erythematosus

An Integrative Mechanistic Model of Type 1 IFN-Mediated Inflammation in Systemic Lupus Erythematosus. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "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%)."

Journal • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IFNA1

New hope for lupus patients! The First Municipal Hospital is recruiting clinical subjects [Google translation] (Sohu.com) - "The Department of Dermatology and Venereology of Hangzhou First People's Hospital is conducting a '2-part seamless design (Part A [Phase II]/Part B [Phase III]), randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of BIIB059 in subjects with active subacute cutaneous lupus erythematosus and/or chronic cutaneous lupus erythematosus (with or without systemic manifestations) who have an inadequate response and/or intolerance to antimalarial drugs' sponsored by Biogen Idec Research Limited. This study is a global multicenter study and the study drug is BIIB059-BDCA2 monoclonal antibody."

Trial status • Cutaneous Lupus Erythematosus

'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

Litifilimab Reduces Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI-A) Erythema and Scale/Hypertrophy Subcomponents and Shows a Greater Shift Versus Placebo From Severe-To-Moderate Toward Mild, Almost Clear, and Clear Skin Disease Activity (AAD 2025) - P2 | "A greater mean proportion of participants experienced a shift from baseline CLASI-A categories of moderate (CLASI-A score ≥10 and ≤20) or severe (CLASI-A score >20) to clear/almost clear or mild with litifilimab 50 mg (23.1%), 150 mg (40.0%), and 450 mg (46.5%) versus placebo (15.6%). These exploratory analyses support the continued development of litifilimab in CLE."

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

A focused report on IFN-1 targeted therapies for lupus erythematosus. (PubMed, Expert Opin Investig Drugs) - "Despite these challenges, anifrolumab, voclosporin, and belimumab were approved by FDA...This review summarizes the clinical trial outcomes of four upcoming medications targeting cytokine activity: Litifilimab showed a 7-point reduction in CLASI-A in its phase II trial. Daxdilimab was unsuccessful in its phase II trial...Anifrolumab binds to the IFN-I receptor, blocking the activity of all IFN-Is, and deucravacitinib reduces IFN-I by inhibiting TYK2, thereby interfering with downstream signaling. Therapies that target IFN-I represents a promising class of medications for SLE patients."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • TYK2

Part A of the LILAC study of litifilimab for systemic lupus erythematosus: a plain language summary. (PubMed, Immunotherapy) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Part B of the LILAC study of litifilimab for cutaneous lupus erythematosus: a plain language summary. (PubMed, Immunotherapy) - No abstract available

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

Royalty Pharma Announces R&D Funding Collaboration With Biogen (GlobeNewswire) - "Royalty Pharma plc...announced that it has entered into an agreement with Biogen to provide research and development (R&D) funding of up to $250 million for litifilimab, a first-in-class investigational drug candidate in Phase 3 with demonstrated proof-of-concept in both systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)....Litifilimab is currently in Phase 3 trials for both SLE and CLE with results expected between 2026 and 2027."

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