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NCT06195072
Platform Clinical Study for Conquering Scleroderma
Conditions: Interstitial Lung Disease Due to Systemic Disease, Scleroderma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 400
Sponsor: Scleroderma Research Foundation, Inc.
Location: University of Alabama - Division of Pulmonary and Critical Care Medicine Birmingham Alabama
Summary
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.
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 \
Source: ClinicalTrials.gov (NCT06195072). StuddyBuddy aggregates publicly available trial information.