Systemic Sclerosis
Conditions
Brief summary
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
Detailed description
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)
Interventions
DRUGTibulizumab
Sponsors
Zura Bio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Hungary, Poland, Romania, Spain
Outcome results
None listed