RecruitingPhase 2NCT06470048

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

Sponsor

Novartis Pharmaceuticals

Enrollment

200 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

Diffuse Cutaneous Systemic Sclerosis

Summary

The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ianalumab and a drug called Placebo for people with diffuse cutaneous systemic sclerosis. The study is currently recruiting participants at 128 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol

DRUGIanalumab

subcutaneous (s.c.) injection as defined in the protocol

Locations(128)

Arizona Arthritis and Rheumatology Research PLLC

Mesa, Arizona, United States

UCLA

Los Angeles, California, United States

Hoag Hospital

Newport Beach, California, United States

Clinical Res Of W Florida

Clearwater, Florida, United States

GNP Research

Cooper City, Florida, United States

IRIS Research and Development

Plantation, Florida, United States

Sarasota Arthritis Res Ctr

Sarasota, Florida, United States

University of Chicago Hospitals

Chicago, Illinois, United States

UMC New Orleans

New Orleans, Louisiana, United States

Uni Of Michigan Health System

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Clinical Research Inst of MI

Saint Clair Shores, Michigan, United States

Hospital for Special Surgery

New York, New York, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

Arthritis and Rheumatology Ins

Allen, Texas, United States

Novel Research LLC

Bellaire, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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Caba, Argentina

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Caba, Argentina

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San Miguel de Tucumán, Argentina

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Graz, Austria

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Leuven, Belgium

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Salvador, Estado de Bahia, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Sao Jose Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Nanning, Guangxi, China

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Zhengzhou, Henan, China

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Changchun, Jilin, China

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Chengdu, Sichuan, China

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Ningbo, Zhejiang, China

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Beijing, China

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Beijing, China

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Tianjin, China

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Medellín, Antioquia, Colombia

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Bogota, Cundinamarca, Colombia

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Bogota, Cundinamarca, Colombia

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Cali, Valle del Cauca Department, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Dijon, France

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Le Mans, France

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Lille, France

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Montpellier, France

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Paris, France

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Rennes, France

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Strasbourg, France

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Toulouse, France

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Würzburg, Bavaria, Germany

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Jena, Thuringia, Germany

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Berlin, Germany

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Alexandroupoli, Greece

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Athens, Greece

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Athens, Greece

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Pécs, Baranya, Hungary

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Debrecen, Hajdu Bihar Megye, Hungary

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Budapest, Hungary

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Kochi, Kerala, India

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Mumbai, Maharashtra, India

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Mumbai, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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New Delhi, New Delhi, India

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Jaipur, Rajasthan, India

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Ancona, AN, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

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Modena, MO, Italy

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Palermo, PA, Italy

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Pavia, PV, Italy

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Roma, RM, Italy

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Verona, VR, Italy

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Nagoya, Aichi-ken, Japan

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Toyoake, Aichi-ken, Japan

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Kitakyushu, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Yokohama, Kanagawa, Japan

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Suita, Osaka, Japan

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Iruma-gun, Saitama, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo Ku, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Toyama, Toyama, Japan

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Fukuoka, Japan

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Hiroshima, Japan

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Ishikawa, Japan

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Kyoto, Japan

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Cheras, Kuala Lumpur, Malaysia

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Kuala Lumpur, Malaysia

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Chihuahua City, Chihuahua, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Bydgoszcz, Poland

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Warsaw, Poland

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Coimbra, Portugal

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Lisbon, Portugal

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Vila Nova de Gaia, Portugal

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Seoul, Seoul, South Korea

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Busan, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Málaga, Andalusia, Spain

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Valencia, Valencia, Spain

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Barcelona, Spain

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Madrid, Spain

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Salamanca, Spain

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Changhua, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taoyuan, Taiwan

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Khon Kaen, THA, Thailand

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Bangkok, Thailand

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Istanbul, Fatih, Turkey (Türkiye)

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Ankara, Sihhiye-Altindag, Turkey (Türkiye)

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Ankara, Yenimahalle, Turkey (Türkiye)

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Basingstoke, Hampshire, United Kingdom

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Bristol, United Kingdom

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London, United Kingdom

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Ho Chi Minh City, VNM, Vietnam

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Ho Chi Minh City, Vietnam

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NCT06470048

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