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NCT06470048

PHASE2

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-10-09

Completion Date

2030-07-15

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Diffuse Cutaneous Systemic Sclerosis

Interventions

DRUG

Placebo

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

DRUG

Ianalumab

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

Key Inclusion Criteria: * Male and female participants \>= 18 and =\< 70 years (at the time of the screening visit). * Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy 1988) * Disease duration of =\< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) * mRSS units of \>= 15 and =\< 45 at the time of the screening visit * Active disease that meets at least one of the following criteria at screening: * Disease duration of =\< 18 months defined as time from the first non-Raynaud phenomenon manifestation * Increase in mRSS of \>= 3 units compared with the most recent assessment performed within the previous 6 months * Involvement of one new body area and an increase in mRSS of \>= 2 units compared with the most recent assessment performed within the previous 6 months * Involvement of two new body areas within the previous 6 months * Elevated acute phase reactants (ESR) \>= 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) \>= 6 mg/L) * Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity * Modified EUSTAR disease activity index (mDAI) ≥ 2.5 * Participant must be positive for at least one of the following autoantibodies: * anti-topoisomerase I (ATA) (also known as anti-SCL-70) * anti-RNA polymerase III (anti-RNAP3) * anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA /anti-RNAP3) will be limited to 30% of the overall randomized study population. Key Exclusion Criteria: * Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary. * Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit * Previous improvement (decrease) in mRSS \> 10 units * Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit * WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease * Participants treated with cyclophosphamide within 12 weeks prior to Baseline. * Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower). * Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria. * Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit. * Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded. * Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation. * Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for 6 months after stopping study treatment. Other protocol-defined inclusion/exclusion criteria may apply.

Locations (127)

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

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

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

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

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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Jaipur, Rajasthan, India

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New Delhi, 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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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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Kanazawa, Ishikawa-ken, Japan

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Yokohama, Kanagawa-ku, 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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Fukuoka, Japan

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Hiroshima, Japan

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Kyoto, Japan

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Toyama, Japan

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Cheras, Kuala Lumpur, Malaysia

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Kuala Lumpur, Malaysia

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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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Chihuahua City, 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, Korea, 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 District, 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

Novartis Investigative Site

Ho Chi Minh City, Vietnam

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (127)