New drug trial aims to tame hardening skin and lung damage in scleroderma

NCT ID NCT06470048

Recruiting now Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests whether the drug ianalumab can help people with diffuse cutaneous systemic sclerosis, a condition that causes skin thickening and can damage internal organs like the lungs. About 200 adults will receive either ianalumab or a placebo as a shot under the skin. Researchers will check if the drug improves skin and lung function after one year.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ianalumab (a drug given as a shot under the skin)
What this could lead to: If it works, this could point toward a new treatment option to control skin and lung complications in people with diffuse cutaneous systemic sclerosis.
What could go wrong: This is an early Phase 2 trial with only 200 participants, so results may not confirm benefit. The drug may cause side effects or fail to outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

diffuse cutaneous systemic sclerosis diffuse scleroderma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS

Contacts and locations

Locations

Arizona Arthritis and Rheumatology Research PLLC
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Mesa, Arizona, 85202, United States
Arthritis and Rheumatology Ins
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Allen, Texas, 75035, United States
Clinical Res Of W Florida
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Clearwater, Florida, 33765, United States
Clinical Research Inst of MI
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Saint Clair Shores, Michigan, 48081, United States
GNP Research
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Cooper City, Florida, 33024, United States
Hoag Hospital
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Newport Beach, California, 92663, United States
Hospital for Special Surgery
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New York, New York, 10021, United States
IRIS Research and Development
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Plantation, Florida, 33324, United States
Novartis Investigative Site
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CABA, Buenos Aires, C1221ADC, Argentina
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CABA, Buenos Aires, C1280AEB, Argentina
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Caba, C1015ABO, Argentina
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Caba, C1427CCL, Argentina
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San Miguel de Tucumán, T4000AXL, Argentina
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Graz, 8036, Austria
Novartis Investigative Site
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Leuven, 3000, Belgium
Novartis Investigative Site
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Salvador, Estado de Bahia, 40150 150, Brazil
Novartis Investigative Site
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Curitiba, Paraná, 80030-110, Brazil
Novartis Investigative Site
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Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
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Sao Jose Rio Preto, São Paulo, 15090 000, Brazil
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São Paulo, São Paulo, 04038-002, Brazil
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São Paulo, São Paulo, 05403-000, Brazil
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Nanning, Guangxi, 530021, China
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Zhengzhou, Henan, 450003, China
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Changchun, Jilin, 130021, China
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Chengdu, Sichuan, 610041, China
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Ningbo, Zhejiang, 315016, China
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Beijing, 100191, China
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Beijing, 100730, China
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Tianjin, 300052, China
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Medellín, Antioquia, 050001, Colombia
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Bogota, Cundinamarca, 110111, Colombia
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Bogota, Cundinamarca, 110221, Colombia
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Cali, Valle del Cauca Department, 760012, Colombia
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Bogotá, 110231, Colombia
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Medellín, 050034, Colombia
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Dijon, 21000, France
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Le Mans, 72000, France
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Lille, 59037, France
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Montpellier, 34295, France
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Paris, 75014, France
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Rennes, 35033, France
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Strasbourg, 67000, France
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Toulouse, 31054, France
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Würzburg, Bavaria, 97080, Germany
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Jena, Thuringia, 07740, Germany
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Berlin, 13353, Germany
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Alexandroupoli, 681 00, Greece
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Athens, 115 21, Greece
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Athens, 115 27, Greece
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Pécs, Baranya, 7623, Hungary
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Debrecen, Hajdu Bihar Megye, 4032, Hungary
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Budapest, H-1083, Hungary
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Kochi, Kerala, 682018, India
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Mumbai, Maharashtra, 400013, India
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Mumbai, Maharashtra, 400078, India
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New Delhi, National Capital Territory of Delhi, 110060, India
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New Delhi, New Delhi, 110029, India
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Jaipur, Rajasthan, 302004, India
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Ancona, AN, 60020, Italy
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Milan, MI, 20100, Italy
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Rozzano, MI, 20089, Italy
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Modena, MO, 41124, Italy
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Palermo, PA, 90127, Italy
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Pavia, PV, 27100, Italy
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Roma, RM, 00168, Italy
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Verona, VR, 37134, Italy
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Nagoya, Aichi-ken, 4578510, Japan
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Toyoake, Aichi-ken, 4701192, Japan
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Kitakyushu, Fukuoka, 8078556, Japan
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Maebashi, Gunma, 3718511, Japan
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Sapporo, Hokkaido, 060-8648, Japan
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Sapporo, Hokkaido, 0608543, Japan
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Yokohama, Kanagawa, 236-0004, Japan
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Suita, Osaka, 565-0871, Japan
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Iruma-gun, Saitama, 3500495, Japan
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Bunkyo-ku, Tokyo, 113-8603, Japan
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Chuo Ku, Tokyo, 104-8560, Japan
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Shinjuku Ku, Tokyo, 1628666, Japan
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Shinjuku-ku, Tokyo, 1608582, Japan
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Toyama, Toyama, 9300194, Japan
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Fukuoka, 8128582, Japan
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Hiroshima, 7348551, Japan
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Ishikawa, 9208641, Japan
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Kyoto, 6068507, Japan
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Cheras, Kuala Lumpur, 56000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Chihuahua City, Chihuahua, 31000, Mexico
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Guadalajara, Jalisco, 44650, Mexico
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Mexico City, Mexico City, 06700, Mexico
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Mexico City, Mexico City, 11850, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Bydgoszcz, 85-168, Poland
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Warsaw, 00-874, Poland
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Coimbra, 3004-561, Portugal
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Lisbon, 1649-035, Portugal
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Vila Nova de Gaia, 4434 502, Portugal
Novartis Investigative Site
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Seoul, Seoul, 03080, South Korea
Novartis Investigative Site
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Busan, 49241, South Korea
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Seoul, 04763, South Korea
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Seoul, 06273, South Korea
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Málaga, Andalusia, 29009, Spain
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Valencia, Valencia, 46017, Spain
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Barcelona, 08041, Spain
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Madrid, 28009, Spain
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Salamanca, 37007, Spain
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Changhua, 50006, Taiwan
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Kaohsiung City, 833, Taiwan
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Taichung, 40447, Taiwan
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Taoyuan, 33305, Taiwan
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Khon Kaen, THA, 40002, Thailand
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Bangkok, 10400, Thailand
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Istanbul, Fatih, 34093, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)
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Ankara, Yenimahalle, 06500, Turkey (Türkiye)
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Basingstoke, Hampshire, RG24 9NA, United Kingdom
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Bristol, BS10 5NB, United Kingdom
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London, NW3 2QG, United Kingdom
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Ho Chi Minh City, VNM, 700000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Novel Research LLC
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Bellaire, Texas, 77401, United States
Prolato Clinical Research Center
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Houston, Texas, 77054, United States
Sarasota Arthritis Res Ctr
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Sarasota, Florida, 34239, United States
UCLA
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Los Angeles, California, 90095, United States
UMC New Orleans
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New Orleans, Louisiana, 70112, United States
Uni Of Michigan Health System
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Ann Arbor, Michigan, 48109, United States
University of Chicago Hospitals
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Chicago, Illinois, 60637, United States
Wayne State University
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Detroit, Michigan, 48201, United States
West Tennessee Research Institute
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Jackson, Tennessee, 38305, United States

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