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Platform Clinical Study for Conquering Scleroderma

RecruitingPhase 2

Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants With Interstitial Lung Disease Secondary to Systemic Sclerosis

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

What is being tested

Sponsor: Scleroderma Research Foundation, Inc. · Participants: 400 · Started: Apr 15, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06195072

Locations in the U.S.

AlabamaUniversity of Alabama - Division of Pulmonary and Critical Care Medicine, Birmingham
CaliforniaCedars-Sinai Medical Center, Los Angeles
Keck School of Medicine at USC Medical Center, Los Angeles
Stanford University Medical Center, Palo Alto
District of ColumbiaGeorgetown University Medical Center - Department of Rheumatology, Washington D.C.
IllinoisThe University of Chicago Medical Center (UCMC), Chicago
KansasUniversity of Kansas School of Medicine, Kansas City
MarylandJohns Hopkins University School of Medicine, Baltimore
MassachusettsBoston University (BU), Boston
Massachusetts General Hospital, Boston
MichiganUniversity of Michigan, Ann Arbor
MinnesotaMayo Clinic, Rochester
New JerseyRobert Wood Johnson Medical School, New Brunswick
New YorkNorthwell Health, Great Neck
Columbia University Medical Center, New York
Hospital for Special Surgery, New York
North CarolinaDuke University Medical Center, Durham
OregonOregon Health &amp; Science University (OHSU), Portland
PennsylvaniaThomas Jefferson University Hospital, Philadelphia
University of Pennsylvania, Philadelphia
South CarolinaMedical University of South Carolina (MUSC), Charleston
TennesseeVanderbilt University Medical Center, Nashville (Not yet recruiting)
TexasUniversity of Texas Houston - Division of Rheumatology and Clinical Immunogenetics, Houston
WisconsinFroedtert Hospital and the Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.