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NCT04961567 · 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
562
Enrollment target
20
Study locations

NCT04961567 is a Phase 3 study of Lupus Erythematosus, Systemic that is active but no longer recruiting, run by Biogen. The registered enrollment target is 562 participants, above the 184-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (205% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT04961567, 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
562 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)

California

  • Care Access Research - Huntington BeachCare Access Research - Huntington Beach - Huntington Beach
  • Valerius Medical Group - Los Alamitos
  • The Practice of Medicine - Los Angeles
  • R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center - Monterey Park
  • Neurovations - Napa
  • Joo-Hyung Lee MD - Orange
  • Medvin Clinical Research - Whittier

Florida

  • RASF - Clinical Research Center - Boca Raton
  • University of Florida - Gainesville
  • Vida Clinical Research - Kissimmee
  • University of Miami Miller School of Medicine - Miami
  • HMD Research, LLC - Orlando
  • Clinical Research of West Florida, Inc. - Tampa

Georgia

  • The Emory Clinic Emory University - Atlanta
  • Jefrey Lieberman, M.D., P.C. - Decatur
  • Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia - Gainesville
  • RNA America Health Sciences - Gainesville
  • EBGS Clinical Trials - Snellville

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • Arizona Arthritis & Rheumatology Associates, P.C. - Glendale

Trial Details

FieldValue
Enrollment Target 562 participants
Start Date 2021-07-16
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 NCT04961567

The ClinicalTrials.gov registry entry for NCT04961567 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 562 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 (205% 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.

NCT04961567 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT04961567 about?

NCT04961567 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 NCT04961567?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 562 participants. The study started on 2021-07-16. Estimated completion is 2027-03-16.

What conditions does trial NCT04961567 study?

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

What interventions are being tested in trial NCT04961567?

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

Who is sponsoring clinical trial NCT04961567?

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

Where is trial NCT04961567 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. 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.