A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (NCT05531565)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Pinnacle Research Group, LLC — Anniston, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (315 Sites)
Showing the first 25 of 315 sites.
- Pinnacle Research Group, LLC — Anniston, Alabama
- UAB Center for Women's Reproductive Health — Birmingham, Alabama
- Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona
- The Regents of the University of California — La Jolla, California
- Dermatology Research Associates — Los Angeles, California
- Clinical Science Institute — Santa Monica, California
- Inland Rheumatology Clinical Trials, Inc. — Upland, California
- Denver Arthritis Clinic — Denver, Colorado
- Omega Research Debary, LLC — DeBary, Florida
- Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida
- University of Florida — Gainesville, Florida
- University of Miami Miller School of Medicine — Miami, Florida
- Millennium Medical Research, LLC — Miami, Florida
- Medical Research Center of Miami — Miami, Florida
- Diverse Clinical Research LLC — Miami, Florida
- Charisma Medical and Research Center — Miami Lakes, Florida
- Leading Edge Dermatology — Plantation, Florida
- Augusta University — Augusta, Georgia
- Rush University Medical Center — Chicago, Illinois
- OrthoIllinois — Rockford, Illinois
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana
- Equity Medical — Bowling Green, Kentucky
- LSU Health Sciences Center Shreveport — New Orleans, Louisiana
- Tufts Medical Center — Boston, Massachusetts
- Brigham And Women's Hospital — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Subacute Cutaneous Lupus Erythematosus
Explore by condition: All Subacute Cutaneous Lupus Erythematosus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.