Clinical Trial Search

Primary: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value — 66.52; 66.52; 66.22; 67.03 FVC %-pred — p=0.24

Primary: Mean Skin Stiffness — 2.68; 2.07; 2.23; 2.27 meters per second — p=0.005

Primary: Flow Mediated Dilatation (FMD)-Diameter of Artery — 3.79; 3.78 mm

Primary: Improvement in the Modified Rodnan Skin Score. — 46.75 percent improvement from baseline

Primary: Forced Vital Capacity — 66.6; 65.6 % of predicted

Primary: Time to Treatment Failure — 0; 8 participants

Primary: Change in Modified Rodnan Skin Score — -8.6; -2.3 MRSS score

Primary: Percent Change in Modified Rodnan Skin Score at 6 Months Compared to Baseline — -32 percentage of change in MRSS — p=0.005

Primary: Change in 2- Gene Biomarker — -2.67; 0.42 2- gene biomarkers score

Primary: EFS of Patients Undergoing Transplant — 15 participants

Primary: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks — -93.3; -52.4 millilitre (mL)/year (yr) — p=0.0350

Primary: Mean Change From Baseline in Forced Vital Capacity (FVC) — 0.1786 Liters — p=0.026

Primary: Percent Predicted Forced Vital Capacity (FVC-%) — 2.24; 2.09 percent predicted — p=0.9326

Primary: Change in Modified Rodnan Skin Score (MRSS) — -10; -3.0 units on a scale

Primary: The Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the…

Primary: Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus — 260.0; 246.3 perfusion units

Primary: Change From Baseline to End of Double-blind Treatment (Week 16) in Digital Ulcer Net Burden — -1.22; -0.98 ulcers — p=0.70

Primary: Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 — -9.5; 3.1 Score on a scale — p=< 0.001

Primary: Change From Baseline in Modified Rodnan Skin Score to Week 24 — -2.45; -4.76 score on a scale — p=0.0291

Primary: Global Rank Composite Score (GRCS) (Month 54, ITT) — 17.0; -6.0 Sum of subject-pair comparison scores — p=0.013

Primary: Cochin Hand Functional Scale — 19.24 units on a scale

Primary: Improvement in the Modified Rodnan Skin Score — -6.6 units on a scale

Primary: New Digital Ulcers (DU) 4 Weeks Prior to Week 24 — 0.06 new digital ulcers

Primary: Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 — 0.35; 0.94; 0.50; 1.49 units on a scale — p=0.87

Primary: Change From Baseline in Distance Walked During a Six Minute Walk Test — 23.6; 0.5 Meters — p=0.12

Primary: Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52 — -2.088; -0.769 score on a scale — p=0.0815

Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 71 Adverse Events

Primary: Change in Modified Rodnan Skin Score (mRSS) During Double-blind Period — -4.41; -6.14 Units on a scale — p=0.0983

Primary: Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24 — 0; 0 Participants

Primary: Proportion of Patients Improving Their EndoPAT Reactive Hyperemia Index (RHI) at the End-of-study (16 Weeks) — 6; 4 Participants