CONQUESTPlatform 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 - SRF201

Scleroderma Research Foundation0 个研究点目标入组 402 人开始时间: 2024年4月8日最近更新: 2024年8月21日

适应症

试验速览

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•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. An enrollment cap will apply to the limited/sine cutaneous SSc subtype. The enrollment cap will allow for =30% of limited/sine cutaneous SSc subtype study participants for each Regimen-specific Subprotocol (IP), Onset of SSc (defined by first non-Raynaud’s symptom) =5 years prior to the Screening Visit, Modified Rodnan skin score (mRSS) of 10 to 35, inclusive, in participants with diffuse cutaneous SSc, Presence of ILD with evidence of any fibrosis on HRCT (within =3 months of randomization), Presence of an FVC =45% predicted normal, Presence of a diffusing capacity of the lung for carbon monoxide =30% predicted normal, corrected for hemoglobin, Other protocol and subprotocol defined criteria apply.

•Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active TB, sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);, History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation, Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study, History of Child-Pugh Class B or Class C liver disease or presence of acute or chronic congestive heart failure, Presence of abnormal laboratory findings at the Screening Visit, History of major trauma or hemorrhage within 30 days of the Screening Visit, History of any clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of the Screening Visit, History of any cerebrovascular events, myocardial infarction or unstable angina, restrictive or congestive cardiomyopathy (other than mild), life-threatening cardiac arrhythmias, hemodynamically significant aortic or mitral valve disease, pulmonary veno-occlusive disease, and scleroderma renal crisis within 6 months prior to the Screening Visit, Other protocol and subprotocol-defined criteria apply

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