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NCT05531565 · ClinicalTrials.gov registry record · Phase 2
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
A Phase 2 study of Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, sponsored by Biogen.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT05531565 is a Phase 2 study of Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus that is actively recruiting participants, run by Biogen. The registered enrollment target is 450 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT05531565, a Phase 2 study of Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Litifilimab
Study Locations (20)
Florida
- Omega Research Debary, LLC - DeBary
- Centre for Rheumatology, Immunology and Arthritis - Fort Lauderdale
- University of Florida - Gainesville
- University of Miami Miller School of Medicine - Miami
- Millennium Medical Research, LLC - Miami
- Medical Research Center of Miami - Miami
- Diverse Clinical Research LLC - Miami
- Charisma Medical and Research Center - Miami Lakes
- Leading Edge Dermatology - Plantation
California
- The Regents of the University of California - La Jolla
- Dermatology Research Associates - Los Angeles
- Clinical Science Institute - Santa Monica
- Inland Rheumatology Clinical Trials, Inc. - Upland
Alabama
- Pinnacle Research Group, LLC - Anniston
- UAB Center for Women's Reproductive Health - Birmingham
Illinois
- Rush University Medical Center - Chicago
- OrthoIllinois - Rockford
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Colorado
- Denver Arthritis Clinic - Denver
Georgia
- Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2027-12-14 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05531565
The ClinicalTrials.gov registry entry for NCT05531565 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Subacute Cutaneous Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05531565 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05531565 about?
NCT05531565 is a clinical study titled "A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus". 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)...
What is the current status of trial NCT05531565?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 450 participants. The study started on 2022-09-13. Estimated completion is 2027-12-14.
What conditions does trial NCT05531565 study?
This clinical trial studies the following conditions: Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus.
What interventions are being tested in trial NCT05531565?
The interventions under investigation include: Placebo (DRUG), Litifilimab (DRUG).
Who is sponsoring clinical trial NCT05531565?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05531565 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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