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COMPLETED Phase 2

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

NCT02847598 · View on ClinicalTrials.gov ↗

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).

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

74 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02847598 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, District of Columbia, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02847598?

The interventions under investigation include: Placebo (DRUG), BIIB059 (litifilimab) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02847598?

This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial