Platform Clinical Study for Conquering Scleroderma (NCT06195072) | Clinical Trial Compass
RecruitingPhase 2
Platform Clinical Study for Conquering Scleroderma
United States400 participantsStarted 2024-04-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female 18+ years of age at the time of signed informed consent;
✓. 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
✓. Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;
✓. A Modified Rodnan skin score (mRSS) less than 40
✓. Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
✓. Presence of an FVC 45% or more predicted normal;
✓. Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin;
Exclusion criteria
✕. 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);
✕. Presence of infected ulcers or active gangrene at the Screening Visit;
✕. History of scleroderma renal crisis within 6 months prior to the Screening Visit;
✕. Forced expiratory volume in 1 second/FVC \<0.65 (pre-bronchodilator) at the Screening Visit
What they're measuring
1
The change in forced vital capacity (FVC, in mL).
Timeframe: from baseline to the end of the treatment period at Week 52
✕. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
✕. History of treatment with rituximab within the 6 months prior to the Screening Visit;
✕. 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
✕. Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit