A Study to Assess the Effectiveness and Safety of BIIB059 (Litifilimab) in Patients With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

RECRUITING

I'm interested ...!!

The primary objectives of the study are to assess the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score \[Parts A and B (US)\] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score \[Part B (ROW)\] in patients with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to assess the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to assess additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 \[Parts A and B\].

Conditions:

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus

Study Start (Actual) 2022-09-13

Primary Completion (Estimated) 2026-10-20

Study Completion (Estimated) 2027-12-14

Enrollment (Estimated) 474

Study Type INTERVENTIONAL

Phase PHASE2

Locations:

📍 Anniston, Alabama, United States

📍 Birmingham, Alabama, United States

📍 Phoenix, Arizona, United States

📍 La Jolla, California, United States

📍 Los Angeles, California, United States

📍 Santa Monica, California, United States

📍 Upland, California, United States

📍 Denver, Colorado, United States

📍 DeBary, Florida, United States

📍 Fort Lauderdale, Florida, United States

📍 Gainesville, Florida, United States

📍 Miami Lakes, Florida, United States

📍 Miami, Florida, United States

📍 Rockford, Illinois, United States

📍 Indianapolis, Indiana, United States

📍 Boston, Massachusetts, United States

📍 Natick, Massachusetts, United States

📍 Quincy, Massachusetts, United States

📍 Worcester, Massachusetts, United States

📍 Ann Arbor, Michigan, United States

📍 Auburn Hills, Michigan, United States

📍 Flint, Michigan, United States

📍 Troy, Michigan, United States

📍 Saint Louis, Missouri, United States

📍 Omaha, Nebraska, United States

📍 Albuquerque, New Mexico, United States

📍 Brooklyn, New York, United States

📍 Fairport, New York, United States

📍 Great Neck, New York, United States

📍 New York, New York, United States

📍 Chapel Hill, North Carolina, United States

📍 Durham, North Carolina, United States

📍 Greensboro, North Carolina, United States

📍 Cincinnati, Ohio, United States

📍 Cleveland, Ohio, United States

📍 Columbus, Ohio, United States

📍 Hershey, Pennsylvania, United States

📍 Philadelphia, Pennsylvania, United States

📍 Nashville, Tennessee, United States

📍 Austin, Texas, United States

📍 Colleyville, Texas, United States

📍 Dallas, Texas, United States

📍 Frisco, Texas, United States

📍 Galveston, Texas, United States

📍 Houston, Texas, United States

📍 Waco, Texas, United States

📍 Salt Lake City, Utah, United States

📍 Richmond, Virginia, United States

📍 Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

📍 Mar del Plata, Buenos Aires, Argentina

📍 Quilmes, Buenos Aires, Argentina

📍 Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

📍 Rosario, Santa Fe, Argentina

📍 San Miguel de Tucuman, Tucuman, Argentina

📍 Buenos Aires, Argentina

📍 Ciudad Autonoma Buenos Aires, Argentina

📍 Mendoza, Argentina

📍 San Juan, Argentina

📍 Salvador, Bahia, Brazil

📍 Fortaleza, Ceará, Brazil

📍 Brasilia, Distrito Federal, Brazil

📍 Vitória, Espírito Santo, Brazil

📍 Santo Ângelo, Mato Grosso, Brazil

📍 Belo Horizonte, Minas Gerais, Brazil

📍 Juiz de Fora, Minas Gerais, Brazil

📍 Rio de Janeiro, Rio Do Janeiro, Brazil

📍 Lajeado, Rio Grande Do Sul, Brazil

📍 Porto Alegre, Rio Grande Do Sul, Brazil

📍 Sao Bernardo Do Campo, Sao Paulo, Brazil

📍 São Paulo, Sao Paulo, Brazil

📍 Pleven, Bulgaria

📍 Ruse, Bulgaria

📍 Sofia, Bulgaria

📍 Calgary, Alberta, Canada

📍 Edmonton, Alberta, Canada

📍 Ottawa, Ontario, Canada

📍 Sudbury, Ontario, Canada

📍 Sherbrooke, Quebec, Canada

📍 Las Condes, Chile

📍 Santiago, Chile

📍 Valdivia, Chile

📍 Viña del Mar, Chile

📍 Dongguan, Guangdong, China

📍 Guangzhou, Guangdong, China

📍 Shenzhen, Guangdong, China

📍 Changsha, Hunan, China

📍 Zhenjiang, Jiangsu, China

📍 Changchun City, Jilin, China

📍 Jinan, Shandong, China

📍 Shanghai, Shanghai, China

📍 Hangzhou, Zhejiang, China

📍 Barranquilla, Atlántico, Colombia

📍 Zipaquirá, Cundinamarca, Colombia

📍 Bucaramanga, Santander, Colombia

📍 Bogotá, Colombia

📍 Nice cedex 3, Alpes Maritimes, France

📍 Marseille cedex 5, Bouches-du-Rhône, France

📍 Caen, Calvados, France

📍 Besançon Cedex, Doubs, France

📍 Toulouse Cedex 9, Haute Garonne, France

📍 Antony, Hauts De Seine, France

📍 Montpellier Cedex 5, Herault, France

📍 Cedex 10, Paris, France

📍 Lyon, Rhone, France

📍 Paris, France

📍 Heidelberg, Baden Wuerttemberg, Germany

📍 Erlangen, Bayern, Germany

📍 Bad Bentheim, Niedersachsen, Germany

📍 Buxtehude, Niedersachsen, Germany

📍 Oldenburg, Niedersachsen, Germany

📍 Bonn, Nordrhein Westfalen, Germany

📍 Muenster, Nordrhein Westfalen, Germany

📍 Halle, Sachsen Anhalt, Germany

📍 Dresden, Sachsen, Germany

📍 Kiel, Schleswig Holstein, Germany

📍 Berlin, Germany

📍 Pecs, Hungary

📍 Bologna, Italy

📍 Brescia, Italy

📍 Firenze, Italy

📍 Genova, Italy

📍 Milano, Italy

📍 Napoli, Italy

📍 Roma, Italy

📍 Nagoya-shi, Aichi-Ken, Japan

📍 Toyoake-shi, Aichi-Ken, Japan

📍 Aomori-shi, Aomori-Ken, Japan

📍 Urayasu-shi, Chiba-Ken, Japan

📍 Yoshida-gun, Fukui-Ken, Japan

📍 Kitakyushu-shi, Fukuoka-Ken, Japan

📍 Sapporo-shi, Hokkaido, Japan

📍 Kakogawa-shi, Hyogo-Ken, Japan

📍 Ono-shi, Hyogo-Ken, Japan

📍 Kanazawa-shi, Ishikawa-Ken, Japan

📍 Kawasaki-shi, Kanagawa-Ken, Japan

📍 Yokohama-shi, Kanagawa-Ken, Japan

📍 Kumamoto-shi, Kumamoto-Ken, Japan

📍 Sendai-shi, Miyagi-Ken, Japan

📍 Nagasaki-Shi, Nagasaki-Ken, Japan

📍 Niigata-shi, Niigata-Ken, Japan

📍 Okayama-shi, Okayama-Ken, Japan

📍 Kawachinagano-shi, Osaka-Fu, Japan

📍 Osaka-shi, Osaka-Fu, Japan

📍 Osakasayama-shi, Osaka-Fu, Japan

📍 Suita-shi, Osaka-Fu, Japan

📍 Takatsuki-shi, Osaka-Fu, Japan

📍 Otsu-shi, Shiga-Ken, Japan

📍 Izumo-shi, Shimane-Ken, Japan

📍 Itabashi-ku, Tokyo-To, Japan

📍 Shinagawa-ku, Tokyo-To, Japan

📍 Wakayama-shi, Wakayama-Ken, Japan

📍 Ansan-si, Gyeonggi-do, Korea, Republic of

📍 Suwon, Gyeonggi-do, Korea, Republic of

📍 Gwangju, Korea, Republic of

📍 Seoul, Korea, Republic of

📍 Ciudad de México, Distrito Federal, Mexico

📍 Mexico, Distrito Federal, Mexico

📍 Guadalajara, Jalisco, Mexico

📍 Cuernavaca, Morelos, Mexico

📍 Merida, Yucatán, Mexico

📍 Aguascalientes, Mexico

📍 Chihuahua, Mexico

📍 Mabalacat, Pampanga, Philippines

📍 Cebu City, Philippines

📍 Lipa City, Philippines

📍 Manila, Philippines

📍 Quezon City, Metro Manila, Philippines

📍 Quezon City, Philippines

📍 San Fenando, La Union, Philippines

📍 Krakow, Poland

📍 Kraków, Poland

📍 Lodz, Poland

📍 Rzeszow, Poland

📍 Warszawa, Poland

📍 Wroclaw, Poland

📍 Coimbra, Portugal

📍 Lisboa, Portugal

📍 Porto, Portugal

📍 Viana do Castelo, Portugal

📍 Caguas, Puerto Rico

📍 San Juan, Puerto Rico

📍 Riyadh, Saudi Arabia

📍 Belgrade, Serbia

📍 Novi Sad, Serbia

📍 Kosice, Slovakia

📍 Piestany, Slovakia

📍 Badalona, Barcelona, Spain

📍 Valladolid, Cantabria, Spain

📍 Alcorcón, Madrid, Spain

📍 Majadahonda, Madrid, Spain

📍 Barcelona, Spain

📍 Cordoba, Spain

📍 La Coruña, Spain

📍 Sevilla, Spain

📍 Stockholm, Sweden

📍 Lausanne, Switzerland

📍 St. Gallen, Switzerland

📍 Changhua, Taiwan

📍 Kaohsiung, Taiwan

📍 Taichung, Taiwan

📍 Taipei, Taiwan

📍 London, Greater London, United Kingdom

📍 Manchester, Greater Manchester, United Kingdom

📍 Birmingham, West Midlands, United Kingdom

📍 Leeds, West Yorkshire, United Kingdom

More locations available...

Eligibility Criteria

Description

Inclusion Criteria:

1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
2. Must have active cutaneous manifestations that meet study criteria.
3. Must have a CLASI-A score ≥10.
4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Exclusion Criteria:

1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
2. Active severe lupus nephritis.
3. Active neuropsychiatric SLE.
4. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
5. Use of immunosuppressive or disease-modifying treatments for SLE or CLE \[via an oral, intravenous (IV), or SC route\] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-08-19
First Submitted that Met QC Criteria2022-09-02
First Posted2022-09-08

Study Record Updates

Last Update Submitted that Met QC Criteria2024-07-29
Last Update Posted2024-07-30
Last Verified2024-07