Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Primary Outcome Measures

1. [Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks
   The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)
2. [Period 2] Safety and tolerability of tibulizumab
   Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results

Secondary Outcome Measures

1. [Period 1] Change from baseline in quantitative interstitial lung disease (QILD) obtained with high-resolution quantitative tomography (HRCT) in the whole lung in participants with SSc-interstitial lung disease (ILD)
   HRCT measures the extent of interstitial lung disease by quantifying the amount of lung fibrosis, ground-glass opacity, and honeycomb lung, which are used to calculate the QILD score (scores can range from 0 to 100%, with higher scores indicating greater disease extent)
2. [Period 1] Change from baseline in forced vital capacity (FVC) in participants with SSc-ILD
   FVC is the amount of air that can be forcibly exhaled after the deepest possible breath
3. [Period 1] Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
   HAQ-DI evaluates patients' self-assessed degree of disability across eight categories, with scores ranging from 0 to 3, where 3 indicates the worst degree of disability
4. [Period 1] Safety and tolerability of tibulizumab
   Assessed by the incidence of all TEAEs, as well as changes from baseline in vital signs, ECG parameters, and laboratory results
5. [Period 2] Change from baseline in mRSS
   The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)
6. [Period 2] Change from baseline in QILD obtained with HRCT in the whole lung in participants with SSc-ILD
   HRCT measures the extent of interstitial lung disease by quantifying the amount of lung fibrosis, ground-glass opacity, and honeycomb lung, which are used to calculate the QILD score (scores can range from 0 to 100%, with higher scores indicating greater disease extent)