A Study Evaluating the Effectiveness and Safety of Afimetoran Compared With Placebo in Patients With Active Lupus (SLE)

RECRUITING

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The purpose of this study is to assess the effectiveness, safety and tolerability of Afimetoran in patients with active Lupus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those patients initially randomized to placebo to receive treatment with Afimetoran.

Conditions:

Systemic Lupus Erythematosus

Study Start (Actual) 2021-10-11

Primary Completion (Estimated) 2026-03-29

Study Completion (Estimated) 2029-04-22

Enrollment (Estimated) 268

Study Type INTERVENTIONAL

Phase PHASE2

Locations:

📍 Birmingham, Alabama, United States

📍 Fullerton, California, United States

📍 Huntington Beach, California, United States

📍 La Jolla, California, United States

📍 La Palma, California, United States

📍 Los Angeles, California, United States

📍 San Diego, California, United States

📍 West Hills, California, United States

📍 Woodland Hills, California, United States

📍 Denver, Colorado, United States

📍 Farmington, Connecticut, United States

📍 Brandon, Florida, United States

📍 Clearwater, Florida, United States

📍 Gainesville, Florida, United States

📍 Kissimmee, Florida, United States

📍 Orlando, Florida, United States

📍 Ormond Beach, Florida, United States

📍 Plantation, Florida, United States

📍 South Miami, Florida, United States

📍 Tamarac, Florida, United States

📍 Atlanta, Georgia, United States

📍 Decatur, Georgia, United States

📍 Lawrenceville, Georgia, United States

📍 Orland Park, Illinois, United States

📍 Hopkinsville, Kentucky, United States

📍 Baton Rouge, Louisiana, United States

📍 Wheaton, Maryland, United States

📍 Rochester Hills, Michigan, United States

📍 Eagan, Minnesota, United States

📍 Saint Louis, Missouri, United States

📍 Las Vegas, Nevada, United States

📍 West Long Branch, New Jersey, United States

📍 Bronx, New York, United States

📍 Manhasset, New York, United States

📍 Charlotte, North Carolina, United States

📍 Columbus, Ohio, United States

📍 Middleburg Heights, Ohio, United States

📍 Oklahoma City, Oklahoma, United States

📍 Memphis, Tennessee, United States

📍 Allen, Texas, United States

📍 Amarillo, Texas, United States

📍 Mesquite, Texas, United States

📍 San Antonio, Texas, United States

📍 Bellevue, Washington, United States

📍 Quilmes, Buenos Aires, Argentina

📍 San Fernando, Buenos Aires, Argentina

📍 Córdoba, Cordoba, Argentina

📍 Buenos Aires, Distrito Federal, Argentina

📍 Caba, Distrito Federal, Argentina

📍 San Miguel de Tucumán, Tucuman, Argentina

📍 Buenos Aires, Argentina

📍 San Juan, Argentina

📍 Botany, New South Wales, Australia

📍 Westmead, New South Wales, Australia

📍 Maroochydore, Queensland, Australia

📍 Woodville, South Australia, Australia

📍 Camberwell, Victoria, Australia

📍 Ivanhoe, Victoria, Australia

📍 Salvador, Bahia, Brazil

📍 Cuiabá, Mato Grosso, Brazil

📍 Juiz de Fora, Minas Gerais, Brazil

📍 Curitiba, Parana, Brazil

📍 Porto Alegre, RIO Grande DO SUL, Brazil

📍 São Bernardo do Campo, SAO Paulo, Brazil

📍 São José do Rio Preto, SAO Paulo, Brazil

📍 São Paulo, SAO Paulo, Brazil

📍 São Paulo, Brazil

📍 Osorno, LOS Lagos, Chile

📍 Valdivia, Los Rios, Chile

📍 Santiago, Metropolitana, Chile

📍 Santiago, Región Metropolitana De Santiago, Chile

📍 Beijing, Beijing, China

📍 Shenzhen, Guangdong, China

📍 Baoding, Hebei, China

📍 Nanjing, Jiangsu, China

📍 Suzhou, Jiangsu, China

📍 Changchun, Jilin, China

📍 Dalian, Liaoning, China

📍 Jinan, Shandong, China

📍 Jining, Shandong, China

📍 Changzhi, Shanxi, China

📍 Kunming, Yunnan, China

📍 Beijing, China

📍 Medellín, Antioquia, Colombia

📍 Cali, Valle Del Cauca, Colombia

📍 Barranquilla, Colombia

📍 Bogotá, Colombia

📍 Cali, Colombia

📍 Chía, Colombia

📍 Zipaquira, Colombia

📍 Pessac, Aquitaine, France

📍 Brest, Finistère, France

📍 Bordeaux, France

📍 Caen, France

📍 Lille Cedex, France

📍 Marseille, France

📍 Strasbourg, France

📍 Köln, Nordrhein-Westfalen, Germany

📍 Berlin, Germany

📍 Essen, Germany

📍 Freiburg, Germany

📍 New Delhi, Delhi, India

📍 Gurugram, Haryana, India

📍 Bangalore, Karnataka, India

📍 Secunderabad, Telangana, India

📍 Manorhamilton, Leitrim, Ireland

📍 Dublin, Ireland

📍 Galway, Ireland

📍 Eiheiji-cho,Yoshida-gun, Fukui, Japan

📍 Kitakyushu, Fukuoka, Japan

📍 Sapporo, Hokkaido, Japan

📍 Kanazawa, Ishikawa, Japan

📍 Sendai-shi, Miyagi, Japan

📍 Bunkyo-ku, Tokyo, Japan

📍 Fuchu, Tokyo, Japan

📍 Itabashiku, Tokyo, Japan

📍 Meguro-ku, Tokyo, Japan

📍 Shinjuku-ku, Tokyo, Japan

📍 Aichi, Japan

📍 Chiba, Japan

📍 Fukushima, Japan

📍 Tokyo, Japan

📍 Mexico City, Distrito Federal, Mexico

📍 Leon, Guanajuato, Mexico

📍 Guadalajara, Jalisco, Mexico

📍 Zapopan, Jalisco, Mexico

📍 Monterrey, Nuevo LEON, Mexico

📍 Chihuahua, Mexico

📍 Merida, Mexico

📍 Warszawa, Mazowieckie, Poland

📍 Łomża, Podlaskie, Poland

📍 Bydgoszcz, Poland

📍 Poznan, Poland

📍 Rzeszów, Poland

📍 Sosnowiec, Poland

📍 Warszawa, Poland

📍 Wrocław, Poland

📍 San Juan, Puerto Rico

📍 Bucharest, Romania

📍 Giroc, Romania

📍 Râmnicu Vâlcea, Romania

📍 Santander, Cantabria, Spain

📍 A Coruña, Spain

📍 Barcelona, Spain

📍 Madrid, Spain

📍 Sevilla, Spain

📍 Kaohsiung Niao Sung Dist, Taiwan

📍 Taichung, Taiwan

📍 Taipei, Taiwan

📍 Cambridge, Cambridgeshire, United Kingdom

📍 Bradford, United Kingdom

📍 Edinburgh, United Kingdom

📍 Manchester, United Kingdom

More locations available...

Eligibility Criteria

Description

Inclusion Criteria:

* Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
* Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
* Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash

Exclusion Criteria:

* Active severe lupus nephritis (LN) as assessed by the investigator
* Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
* Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
* Antiphospholipid Syndrome
Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study: 18 Years to 70 Years (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 Submitted2021-05-19
First Submitted that Met QC Criteria2021-05-19
First Posted2021-05-20

Study Record Updates

Last Update Submitted that Met QC Criteria2024-07-10
Last Update Posted2024-07-12
Last Verified2024-07