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New hope for scleroderma lung disease: major trial underway

NCT ID NCT06195072

Disease control Sponsor: Scleroderma Research Foundation, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests whether new investigational drugs can improve lung function in people with scleroderma-related lung scarring. About 400 adults with this condition will receive either the study drug or a placebo for 52 weeks. The main goal is to see if the drug helps preserve or improve breathing capacity.

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 400 people

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

Started

Apr 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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.

Inclusion Criteria: 1. Male or female 18+ years of age at the time of signed informed consent; 2. SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible 3. Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit; 4. A Modified Rodnan skin score (mRSS) less than 40 5. Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization) 6. Presence of an FVC 45% or more predicted normal; 7. Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin; Other protocol and/or subprotocol inclusion criteria apply. Exclusion Criteria: 1. Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis \[TB\], sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator); 2. Presence of infected ulcers or active gangrene at the Screening Visit; 3. History of scleroderma renal crisis within 6 months prior to the Screening Visit; 4. Forced expiratory volume in 1 second/FVC \<0.65 (pre-bronchodilator) at the Screening Visit 5. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation; 6. History of treatment with rituximab within the 6 months prior to the Screening Visit; 7. History treatment with cell-depleting therapies other than rituximab, including, but not limited to, CAMPATH®; anti-cluster of differentiation (CD)3, anti-CD4, anti-CD5, antiCD19, and anti-CD20 agents; and investigational agents 8. Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit 9. History of use of any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer) prior to Screening Visit. 10. Presence of any of the following laboratory findings at the Screening Visit: * Estimated glomerular filtration rate \<45 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration equation; * Alanine aminotransferase or aspartate aminotransferase level \> (2 x ULN); * Platelets \<100 × 109/L (100,000/μL); * White blood cell count \<2500/μL; * Neutrophil blood count \<1500/μL; * Prothrombin time and partial thromboplastin time \>1.5 × ULN, or international normalized ratio \>2; or * Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study. 11. Presence of a clinically significant disorder that, in the opinion of the Investigator, could contraindicate the administration of study product, affect compliance, interfere with study evaluations, or confound the interpretation of study results 12. Presence of a concomitant life-threatening disease with life expectancy \<12 months based on the Investigator's assessment; 13. Evidence of active tuberculosis (TB) or being at high risk for TB Other protocol and/or subprotocol exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma interstitial lung disease pulmonary systemic sclerosis scleroderma systemic sclerosis

As listed by the trial registrant

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

Interstitial lung disease due to systemic disease Scleroderma

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Boston University (BU)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    WITHDRAWN

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University School of Medicine

    WITHDRAWN

    Atlanta, Georgia, 30322, United States

  • Froedtert Hospital and the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Georgetown University Medical Center - Department of Rheumatology

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

  • Johns Hopkins University School of Medicine

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Keck School of Medicine at USC Medical Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29404, United States

  • Meharry Medical College

    WITHDRAWN

    Nashville, Tennessee, 37208, United States

  • Northwell Health

    RECRUITING

    Great Neck, New York, 11021, United States

  • Northwestern University

    COMPLETED

    Chicago, Illinois, 60611, United States

  • Oregon Health &amp; Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97239, United States

  • Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Stanford University Medical Center

    RECRUITING

    Palo Alto, California, 94305, United States

  • Temple University Hospital

    WITHDRAWN

    Philadelphia, Pennsylvania, 19140, United States

  • The University of Chicago Medical Center (UCMC)

    RECRUITING

    Chicago, Illinois, 60637, United States

  • The University of Utah Health Sciences Center

    WITHDRAWN

    Salt Lake City, Utah, 84112, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of Alabama - Division of Pulmonary and Critical Care Medicine

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of California, Los Angeles (UCLA) Ronald Reagan Medical Center

    WITHDRAWN

    Los Angeles, California, 90095-7436, United States

  • University of Kansas School of Medicine

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109-0370, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics

    RECRUITING

    Houston, Texas, 77030, United States

  • Vanderbilt University Medical Center

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37208, United States

  • Washington University School of Medicine

    WITHDRAWN

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine - Epilepsy

    WITHDRAWN

    New Haven, Connecticut, 06520, United States

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