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

NCT ID NCT06470048

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 6 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jul 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    96 sites in 21 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Arthritis and Rheumatology Research PLLC

    RECRUITING

    Mesa, Arizona, 85202, United States

  • Arthritis and Rheumatology Ins

    RECRUITING

    Allen, Texas, 75035, United States

  • Clinical Res Of W Florida

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Clinical Research Inst of MI

    RECRUITING

    Saint Clair Shores, Michigan, 48081, United States

  • GNP Research

    RECRUITING

    Cooper City, Florida, 33024, United States

  • Hoag Hospital

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

  • IRIS Research and Development

    RECRUITING

    Plantation, Florida, 33324, United States

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    CABA, Buenos Aires, C1221ADC, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1280AEB, Argentina

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Caba, C1015ABO, Argentina

  • Novartis Investigative Site

    RECRUITING

    Caba, C1427CCL, Argentina

  • Novartis Investigative Site

    RECRUITING

    San Miguel de Tucumán, T4000AXL, Argentina

  • Novartis Investigative Site

    RECRUITING

    Graz, 8036, Austria

  • Novartis Investigative Site

    RECRUITING

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    RECRUITING

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Novartis Investigative Site

    RECRUITING

    Curitiba, Paraná, 80030-110, Brazil

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

  • Novartis Investigative Site

    RECRUITING

    Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

  • Novartis Investigative Site

    RECRUITING

    Nanning, Guangxi, 530021, China

  • Novartis Investigative Site

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    RECRUITING

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    RECRUITING

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100191, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300052, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Medellín, Antioquia, 050001, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bogota, Cundinamarca, 110111, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bogota, Cundinamarca, 110221, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Cali, Valle del Cauca Department, 760012, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bogotá, 110231, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Medellín, 050034, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Dijon, 21000, France

  • Novartis Investigative Site

    RECRUITING

    Le Mans, 72000, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Lille, 59037, France

  • Novartis Investigative Site

    RECRUITING

    Montpellier, 34295, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Paris, 75014, France

  • Novartis Investigative Site

    RECRUITING

    Rennes, 35033, France

  • Novartis Investigative Site

    RECRUITING

    Strasbourg, 67000, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31054, France

  • Novartis Investigative Site

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 13353, Germany

  • Novartis Investigative Site

    RECRUITING

    Alexandroupoli, 681 00, Greece

  • Novartis Investigative Site

    RECRUITING

    Athens, 115 21, Greece

  • Novartis Investigative Site

    RECRUITING

    Athens, 115 27, Greece

  • Novartis Investigative Site

    RECRUITING

    Pécs, Baranya, 7623, Hungary

  • Novartis Investigative Site

    RECRUITING

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kochi, Kerala, 682018, India

  • Novartis Investigative Site

    RECRUITING

    Mumbai, Maharashtra, 400013, India

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Mumbai, Maharashtra, 400078, India

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    New Delhi, New Delhi, 110029, India

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Jaipur, Rajasthan, 302004, India

  • Novartis Investigative Site

    RECRUITING

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20100, Italy

  • Novartis Investigative Site

    RECRUITING

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    RECRUITING

    Modena, MO, 41124, Italy

  • Novartis Investigative Site

    RECRUITING

    Palermo, PA, 90127, Italy

  • Novartis Investigative Site

    RECRUITING

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    RECRUITING

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    RECRUITING

    Nagoya, Aichi-ken, 4578510, Japan

  • Novartis Investigative Site

    RECRUITING

    Toyoake, Aichi-ken, 4701192, Japan

  • Novartis Investigative Site

    RECRUITING

    Kitakyushu, Fukuoka, 8078556, Japan

  • Novartis Investigative Site

    RECRUITING

    Maebashi, Gunma, 3718511, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608543, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608648, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Yokohama, Kanagawa, 2360004, Japan

  • Novartis Investigative Site

    RECRUITING

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    RECRUITING

    Iruma-gun, Saitama, 3500495, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo-ku, Tokyo, 1138603, Japan

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 1048560, Japan

  • Novartis Investigative Site

    RECRUITING

    Shinjuku Ku, Tokyo, 1628666, Japan

  • Novartis Investigative Site

    RECRUITING

    Shinjuku-ku, Tokyo, 1608582, Japan

  • Novartis Investigative Site

    RECRUITING

    Toyama, Toyama, 9300194, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Hiroshima, 7348551, Japan

  • Novartis Investigative Site

    RECRUITING

    Ishikawa, 9208641, Japan

  • Novartis Investigative Site

    RECRUITING

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Cheras, Kuala Lumpur, 56000, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Chihuahua City, Chihuahua, 31000, Mexico

  • Novartis Investigative Site

    RECRUITING

    Guadalajara, Jalisco, 44650, Mexico

  • Novartis Investigative Site

    RECRUITING

    Mexico City, Mexico City, 06700, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Mexico City, Mexico City, 11850, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bydgoszcz, 85-168, Poland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Warsaw, 00-874, Poland

  • Novartis Investigative Site

    RECRUITING

    Coimbra, 3004-561, Portugal

  • Novartis Investigative Site

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Novartis Investigative Site

    RECRUITING

    Vila Nova de Gaia, 4434-502, Portugal

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Busan, 49241, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06273, South Korea

  • Novartis Investigative Site

    RECRUITING

    Málaga, Andalusia, 29009, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, Valencia, 46017, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28009, Spain

  • Novartis Investigative Site

    RECRUITING

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    RECRUITING

    Changhua, 50006, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Khon Kaen, THA, 40002, Thailand

  • Novartis Investigative Site

    RECRUITING

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    RECRUITING

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Basingstoke, Hampshire, RG24 9NA, United Kingdom

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Ho Chi Minh City, VNM, 700000, Vietnam

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Ho Chi Minh City, 700000, Vietnam

  • Novel Research LLC

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Prolato Clinical Research Center

    RECRUITING

    Houston, Texas, 77054, United States

  • Sarasota Arthritis Res Ctr

    ACTIVE_NOT_RECRUITING

    Sarasota, Florida, 34239, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UMC New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Uni Of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Chicago Hospitals

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Wayne State University

    RECRUITING

    Detroit, Michigan, 48201, United States

  • West Tennessee Research Institute

    RECRUITING

    Jackson, Tennessee, 38305, United States

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