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NCT02847598 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

A Phase 2 study of Systemic Lupus Erythematosus and Active Cutaneous Lupus Erythematosus, sponsored by Biogen.

Completed
Registry status
Phase 2
Development phase
264
Enrollment target
20
Study locations

NCT02847598 is a Phase 2 study of Systemic Lupus Erythematosus and Active Cutaneous Lupus Erythematosus that has completed, run by Biogen. The registered enrollment target is 264 participants, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT02847598, a Phase 2 study of Systemic Lupus Erythematosus and Active Cutaneous Lupus Erythematosus, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 2
Development phase
264 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).

Conditions Studied

Systemic Lupus Erythematosus Active Cutaneous Lupus Erythematosus

Interventions

  • DRUG Placebo
  • DRUG BIIB059 (litifilimab)

Study Locations (20)

California

  • TriWest Research Associates, LLC - El Cajon
  • Tien Q Nguyen MD Inc - Fountain Valley
  • MD Med Corp - Hemet
  • Universtiy of California, Irvine - Irvine
  • The Regents of the University of California - La Jolla
  • Purushotham Akther & Rosan Kotha, MD Inc. - La Mesa
  • Dermatology Reserach Associates - Los Angeles
  • University Clinical Trials - San Diego
  • Richard Barthel, MD - Santa Barbara
  • Robin K. Dore, MD, Inc. - Tustin
  • Inland Rheumatology Clinical Trials Inc. - Upland
  • Nazanin Firooz, MD Inc. - West Hills

District of Columbia

  • Medical Faculty Associates, Inc. - Washington D.C.
  • Howard University Hospital - Washington D.C.
  • Washington DC VA Medical Center - Washington D.C.

Alabama

  • Pinnacle Research Group LLC - Anniston

Arizona

  • Arizona Arthritis & Rheumatology - Phoenix

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

Colorado

  • Denver Arthritis Clinic - Denver

Florida

  • Clinical Research of West Florida- Corporate - Clearwater

Trial Details

FieldValue
Enrollment Target 264 participants
Start Date 2016-10-20
Est. Completion 2019-11-18
Phase Phase 2

Sponsor

Biogen

334 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02847598

The ClinicalTrials.gov registry entry for NCT02847598 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (30% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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

NCT02847598 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, District of Columbia, Alabama.

Frequently Asked Questions

What is clinical trial NCT02847598 about?

NCT02847598 is a clinical study titled "Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)". The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosu...

What is the current status of trial NCT02847598?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2016-10-20. Estimated completion is 2019-11-18.

What conditions does trial NCT02847598 study?

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

What interventions are being tested in trial NCT02847598?

The interventions under investigation include: Placebo (DRUG), BIIB059 (litifilimab) (DRUG).

Who is sponsoring clinical trial NCT02847598?

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

Where is trial NCT02847598 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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