A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis

Condition studied

Systemic Sclerosis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Period 1: Change from baseline at Week 24 in modified Rodnan Skin Score (mRSS), Period 2: Incidence of all treatment-emergent adverse events; change in baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results

Endpoint detail

Period 1 and 2: Change from baseline at Week 24 in quantitative interstitial lung disease obtained with high-resolution quantitative tomography in the whole lung, Period 1: Change from baseline at Week 24 in forced vital capacity (mL), Period 1: Change from baseline at Week 24 in Health Assessment Questionnaire Disability Index, Period 1: Incidence of all treatment-emergent adverse events; Change from baseline in vital signs, electrocardiogram parameters, and clinical laboratory results, Period 2: Change from baseline at Week 52 in modified Rodnan Skin Score (mRSS)