A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

ClinicalTrials.gov ID: NCT05531565

Public ClinicalTrials.gov record NCT05531565. 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.

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ClinicalTrials.gov public records Last synced Apr 29, 2026, 8:57 AM EDT

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 Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

Study identification

NCT ID: NCT05531565
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Biogen; Industry
Enrollment: 450 participants

Conditions and interventions

Conditions

Interventions

Litifilimab Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
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: Sep 12, 2022
Primary completion: Oct 19, 2026
Completion: Dec 13, 2027
Last update posted: Apr 22, 2026

2022 – 2027

United States locations

U.S. sites: 61
U.S. states: 23
U.S. cities: 54

Facility	City	State	ZIP	Site status
Pinnacle Research Group, LLC	Anniston	Alabama	36207	Recruiting
UAB Center for Women's Reproductive Health	Birmingham	Alabama	35233-7340	Recruiting
Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona	85032	Recruiting
The Regents of the University of California	La Jolla	California	92037	Recruiting
Dermatology Research Associates	Los Angeles	California	90045	Recruiting
Clinical Science Institute	Santa Monica	California	90404	Completed
Inland Rheumatology Clinical Trials, Inc.	Upland	California	91786	Recruiting
Denver Arthritis Clinic	Denver	Colorado	80230	Completed
Omega Research Debary, LLC	DeBary	Florida	32713	Recruiting
Centre for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida	33334	Completed
University of Florida	Gainesville	Florida	32610	Completed
University of Miami Miller School of Medicine	Miami	Florida	33125	Recruiting
Millennium Medical Research, LLC	Miami	Florida	33126	Recruiting
Medical Research Center of Miami	Miami	Florida	33134	Completed
Diverse Clinical Research LLC	Miami	Florida	33175	Recruiting
Charisma Medical and Research Center	Miami Lakes	Florida	33014	Completed
Leading Edge Dermatology	Plantation	Florida	33317	Recruiting
Augusta University	Augusta	Georgia	30912	Completed
Rush University Medical Center	Chicago	Illinois	60612	Completed
OrthoIllinois	Rockford	Illinois	61114	Completed
Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	46250	Completed
Equity Medical	Bowling Green	Kentucky	42104	Recruiting
LSU Health Sciences Center Shreveport	New Orleans	Louisiana	70112	Recruiting
Tufts Medical Center	Boston	Massachusetts	02111	Recruiting
Brigham And Women's Hospital	Boston	Massachusetts	02115	Recruiting
Essential Dermatology	Natick	Massachusetts	01760	Completed
Beacon Clinical Research, LLC	Quincy	Massachusetts	02169	Completed
University of Massachusetts, Worcester	Worcester	Massachusetts	01655	Completed
David Fivenson, MD, Dermatology, PLLC	Ann Arbor	Michigan	48103	Recruiting
Oakland Hills Dermatology	Auburn Hills	Michigan	48326	Recruiting
AA MRC LLC Ahmed Arif Medical Research Center	Flint	Michigan	48504	Completed
Revival Research Institute, LLC	Troy	Michigan	48084	Recruiting
Saint Louis University	St Louis	Missouri	63110	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	68198	Completed
Albuquerque Center For Rheumatology	Albuquerque	New Mexico	87102	Completed
University of New Mexico School of Medicine	Albuquerque	New Mexico	87106	Completed
NYU Langone Brooklyn	Brooklyn	New York	11220	Recruiting
Universal Dermatology, PLLC	Fairport	New York	14450	Recruiting
Northwell Health, Inc. PRIME	Great Neck	New York	11021	Recruiting
Columbia University Medical center	New York	New York	10032	Recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27514	Recruiting
Duke Dermatology South Durham	Durham	North Carolina	27710	Recruiting
Medication Management, LLC	Greensboro	North Carolina	27405	Completed
University of Cincinnati Department of Dermatology	Cincinnati	Ohio	45219	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	44106	Completed
Ohio State University	Columbus	Ohio	43210	Completed
Penn State University Milton S. Hershey Medical Center	Hershey	Pennsylvania	17033	Completed
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Recruiting
Austin Regional Clinic, P.A.	Austin	Texas	78731	Recruiting
Precision Comprehensive Clinical Research Solutions	Colleyville	Texas	76034	Recruiting
Metroplex Clinical Research Center, LLC	Dallas	Texas	75231	Completed
UT Southwestern Medical Center	Dallas	Texas	75390-8896	Recruiting
North Texas Center for Clinical Research	Frisco	Texas	75034	Recruiting
UTMB Department of Dermatology	Galveston	Texas	77555-0583	Recruiting
University of Texas Health Science Center at Houston	Houston	Texas	77054	Completed
Arthritis & Osteoporosis Clinic	Waco	Texas	76710	Recruiting
Velocity Clinical Research Waco	Waco	Texas	76710	Completed
University of Utah Health Sciences Center	Salt Lake City	Utah	84132	Recruiting
Open Door Clinical Research	Blacksburg	Virginia	24060	Recruiting
West End Dermatology Associates	Richmond	Virginia	23233	Completed

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 252 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05531565, 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 Apr 22, 2026 · Synced Apr 29, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05531565 live on ClinicalTrials.gov.

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