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NCT04895241 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Biogen.

Active
Registry status
Phase 3
Development phase
548
Enrollment target
20
Study locations

NCT04895241 is a Phase 3 study of Lupus Erythematosus, Systemic that is active but no longer recruiting, run by Biogen. The registered enrollment target is 548 participants, above the 184-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (198% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT04895241, a Phase 3 study of Lupus Erythematosus, Systemic, is active but no longer recruiting, sponsored by Biogen.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
548 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 systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: \- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. 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 SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. * Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

Conditions Studied

Lupus Erythematosus, Systemic

Interventions

  • DRUG Placebo
  • DRUG Litifilimab

Study Locations (20)

Florida

  • Arthritis & Rheumatic Disease Specialties - Aventura
  • Highlands Rheumatology - Avon Park
  • Clinical Research of West Florida - Corporate - Clearwater
  • Believe Clinical Trials - Coral Springs
  • Omega Research Consultants - DeBary
  • Centre for Rheumatology, Immunology and Arthritis - Fort Lauderdale
  • GNP Research at Mark Jaffe, MD - Hollywood
  • Life Clinical Trials - Margate
  • Charisma Medical and Research Center - Miami Lakes
  • Rheumatology Associates of Central Florida - Orlando

California

  • Wallace Rheumatic Study Center - Beverly Hills
  • University of Southern California - Los Angeles
  • Providence Facey Medical Foundation - Mission Hills
  • University of California San Diego School of Medicine - San Diego
  • SCLA Management - Thousand Oaks
  • Harbor-UCLA Medical Center - Torrance
  • Inland Rheumatology Clinical Trials, Inc. - Upland

Alabama

  • Tilda Research Birmingham - Homewood

Colorado

  • University of Colorado Anschutz Medical Campus - Aurora

District of Columbia

  • Georgetown University Hospital-Medstar - Washington D.C.

Trial Details

FieldValue
Enrollment Target 548 participants
Start Date 2021-05-25
Est. Completion 2027-03-16
Phase Phase 3

Sponsor

Biogen

334 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04895241

The ClinicalTrials.gov registry entry for NCT04895241 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 548 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 184-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (198% higher). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04895241 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT04895241 about?

NCT04895241 is a clinical study titled "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". In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, stero...

What is the current status of trial NCT04895241?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 548 participants. The study started on 2021-05-25. Estimated completion is 2027-03-16.

What conditions does trial NCT04895241 study?

This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.

What interventions are being tested in trial NCT04895241?

The interventions under investigation include: Placebo (DRUG), Litifilimab (DRUG).

Who is sponsoring clinical trial NCT04895241?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04895241 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.