litifilimab (BIIB059) / Biogen, Royalty - LARVOL DELTA

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

Litifilimab: Data readout from P3 AMETHYST trial (NCT05531565) for active cutaneous lupus erythematosus in 2026/2027 (Biogen) - Q4 & FY2024 Results: Data readout from P3 TOPAZ-1 trial (NCT04895241) for SLE in 2026

P3 data • Cutaneous Lupus Erythematosus • Lupus • 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=236 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open

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=540 | Recruiting | Sponsor: Biogen | Trial completion date: Sep 2025 ➔ Mar 2027 | Trial primary completion date: Mar 2025 ➔ Sep 2026

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

EMERALD: An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=864 | Enrolling by invitation | Sponsor: Biogen | Trial completion date: Mar 2029 ➔ Mar 2030 | Trial primary completion date: Mar 2029 ➔ Mar 2030

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • 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=540 | Recruiting | Sponsor: Biogen | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2026

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

Deucravacitinib shows superior efficacy and safety in cutaneous lupus erythematosus compared to various biologics and small molecules - A systematic review and META-analysis. (PubMed, Autoimmun Rev) - "Anifrolumab and litifilimab are effective and safe treatment options in CLE. However, deucravacitinib demonstrated superior efficacy and safety with fewer adverse events compared to anifrolumab. CLE patients who have shown an inadequate response to first- and second-line treatments may benefit from the incorporation of deucravacitinib into their treatment regimens."

Journal • Retrospective data • Review • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • 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=236 | Not yet recruiting | Sponsor: Biogen

New P1 trial

Effect of Litifilimab on Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI-A) Subcomponents and Physician Global Assessment–Skin (PGA–Skin) in Patients with Cutaneous Lupus Erythematosus (CLE) in a Phase 2 Study (ACR Convergence 2024) - P2 | "Results from these post-hoc analyses indicated that the CLASI-A subcomponents of erythema, scale/hypertrophy, alopecia, and recent hair loss contributed to the observed overall CLASI-A score improvements at Week 16. In most subcomponents, greater score improvements were observed in the litifilimab-treated participants compared with placebo. Together with the higher proportion of participants with mild overall skin condition in the litifilimab groups at Week 16, these results support the continued development of litifilimab in CLE.1Werth VP, et al."

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

LBL-047, A NOVEL AFUCOSYLATED ANTI-BDCA2/TACI FUSION PROTEIN WITH YTE MUTATION, INHIBITS THE FUNCTIONS OF BOTH pDCs AND B CELLS (EULAR 2024) - "Blood DC antigen 2 (BDCA2) is exclusively expressed on pDCs and its antibody BIIB059 has demonstrated preliminary efficacy and excellent safety in patients with SLE or cutaneous lupus erythematosus via pDC depletion and inhibition of cytokines release such as IFN-α [5]...In rats, LBL-047(No YTE) exhibited a longer half-life than telitacicept, and the introduction of YTE mutation further extended half-life in humanized FcRn mice. A novel afucosylated bifunctional anti-BDCA2/TACI fusion protein with the YTE mutation, LBL-047 is developed. It is demonstrated extended half-life and dual immunosuppressive functions, simultaneously inhibiting pDC and B cell functions, indicating promising clinical applications for the treatment of autoimmune diseases."

Cutaneous Lupus Erythematosus • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CD34 • IFNA1

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (clinicaltrials.gov) - P2/3 | N=474 | Recruiting | Sponsor: Biogen | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jul 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus

An update on clinical trials for cutaneous lupus erythematosus. (PubMed, J Dermatol) - "Hydroxychloroquine and glucocorticoids are the sole US Food and Drug Administration (FDA)-approved medications for CLE, with numerous off-label treatments available...Promising targeted therapeutic drugs include anifrolumab (anti-type 1 interferon), deucravacitinib (allosteric tyrosine kinase 2 inhibitor), litifilimab (plasmacytoid dendritic cell-directed therapy), iberdomide (cereblon-targeting ligand), and belimumab (B-cell directed therapy). Despite the significant impact of CLE on quality of life, therapeutic options remain inadequate. While promising treatments for cutaneous lupus are emerging, it is crucial to underscore the urgency for skin-focused treatment outcomes and the implementation of validated measures to assess therapeutic effectiveness in clinical trials."

Journal • Review • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CRBN • TYK2

Emerging biologic therapies for systemic lupus erythematosus. (PubMed, Curr Opin Rheumatol) - "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."

Journal • Cutaneous Lupus Erythematosus • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus • TYK2

Litifilimab modulates Type I interferon biomarkers in patients with cutaneous lupus erythematosus: Result of the LILAC Part B Phase 2 study (ISDS 2023) - P2 | "Medical Writing: Selene Medical Communications, funded by Biogen. Abstract first presented at the International Societies for Investigative Dermatology (ISID) 2023 meeting."

Biomarker • Clinical • P2 data • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammatory Arthritis • Lupus • IFNA1

Litifilimab Modulates Type I IFN Biomarkers in Patients with SLE or CLE in the Phase 2 LILAC Study (ACR Convergence 2023) - P2 | "Litifilimab induced a rapid, substantial, and sustained reduction in 22-gene IFNGS scores and IFNa concentrations, and reductions in some biomarkers correlated with clinical responses. These results further support the mechanism of action for litifilimab and the role of Type I IFN and pDCs in SLE and CLE. 5,6 1 Furie R et al."

Biomarker • Clinical • P2 data • Immunology • Inflammatory Arthritis • Lupus • Rheumatology • IL10 • TNFA

The development of litifilimab (BIIB 059) for cutaneous and systemic lupus erythematosus. (PubMed, Immunotherapy) - "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."

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

Emerging immunotherapeutic strategies for cutaneous lupus erythematosus: an overview of recent phase 2 and 3 clinical trials. (PubMed, Expert Opin Emerg Drugs) - "While the recent literature has few trials for CLE, drugs targeting type I interferon, its downstream signaling and plasmacytoid dendritic cells have shown promising results. Further research is required to develop long-awaited effective therapies, and this review highlights the importance of implementing trials dedicated to CLE to fill the current gap in CLE therapeutics."

Journal • P2 data • Review • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

AMETHYST LTE: A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (clinicaltrials.gov) - P3 | N=322 | Enrolling by invitation | Sponsor: Biogen | Not yet recruiting ➔ Enrolling by invitation

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

AMETHYST LTE: A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (clinicaltrials.gov) - P3 | N=322 | Not yet recruiting | Sponsor: Biogen

New P3 trial • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus