Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Public ClinicalTrials.gov record NCT02847598. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02847598
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 264 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 20, 2016 (Actual)
- Primary completion
- Aug 28, 2019 (Actual)
- Completion
- Nov 18, 2019 (Actual)
- Last update posted
- Nov 7, 2023
2016 – 2019
United States locations
- U.S. sites
- 53
- U.S. states
- 24
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group LLC | Anniston | Alabama | 36207 | — |
| Arizona Arthritis & Rheumatology | Phoenix | Arizona | 85037 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | — |
| Tien Q Nguyen MD Inc | Fountain Valley | California | 92708 | — |
| MD Med Corp | Hemet | California | 92543 | — |
| Universtiy of California, Irvine | Irvine | California | 92697 | — |
| The Regents of the University of California | La Jolla | California | 92037 | — |
| Purushotham Akther & Rosan Kotha, MD Inc. | La Mesa | California | 92120 | — |
| Dermatology Reserach Associates | Los Angeles | California | 90045 | — |
| University Clinical Trials | San Diego | California | 92123 | — |
| Richard Barthel, MD | Santa Barbara | California | 93108 | — |
| Robin K. Dore, MD, Inc. | Tustin | California | 92780 | — |
| Inland Rheumatology Clinical Trials Inc. | Upland | California | 91786 | — |
| Nazanin Firooz, MD Inc. | West Hills | California | 91307 | — |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | — |
| Medical Faculty Associates, Inc. | Washington D.C. | District of Columbia | 20037 | — |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | — |
| Washington DC VA Medical Center | Washington D.C. | District of Columbia | 20422 | — |
| Clinical Research of West Florida- Corporate | Clearwater | Florida | 33765 | — |
| Medical Research Center Of Miami | Miami | Florida | 33144 | — |
| Lakes Research, LLC | Miami Lakes | Florida | 33014 | — |
| Omega Research Consultants | Orlando | Florida | 32804 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| DMI Research, Inc. | Pinellas Park | Florida | 33710 | — |
| Advanced Medical Reserarch, PC | Sandy Springs | Georgia | 30328 | — |
| Advanced Clinical Research | Boise | Idaho | 83642 | — |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Davis Group, LTD | Las Vegas | Nevada | 89128 | — |
| Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Institute for Rheumatic & Autoimmune diseases, Overlook Medical Center | Summit | New Jersey | 07901 | — |
| Albuquerque Center For Rheumatology | Albuquerque | New Mexico | 87102 | — |
| North Shore/Long Island Jewish PRIME | Great Neck | New York | 11020 | — |
| Univeristy of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | — |
| American Health Research, Inc. | Charlotte | North Carolina | 28207 | — |
| Medication Management, LLC | Greensboro | North Carolina | 27408 | — |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | — |
| Ohio State University Clinical Trials | Columbus | Ohio | 43215 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC Arthritis Center | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Low Country Rheumatology, PA | North Charleston | South Carolina | 29406 | — |
| University of Tennessee Health Sciences Center | Memphis | Tennessee | 38104 | — |
| Austin Regional Clinic, P.A. | Austin | Texas | 78731 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Accurate Clinical Research, Inc. | Houston | Texas | 77034 | — |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | — |
| Virginia Clinical Research | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02847598, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 7, 2023 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02847598 live on ClinicalTrials.gov.