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Trial · NCT04680975

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYCombined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) Score at Week 24Week 24Analysis was performed on mITT population. Here, overall number of participants analyzed signifies participants with available data for this outcome measure.score on a scaleMEAN
SECONDARYCombined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) Score at Weeks 8, 16, 36, and 52Week 8, 16, 36 and 52Analysis was performed on mITT population. Here, number analyzed signifies participants with available data for each specified category.score on a scaleMEAN
SECONDARYModified Rodnan Skin Score (mRSS) at Week 24Week 24Analysis was performed on mITT population. Here, overall number of participants analyzed signifies participants with available data for this outcome measure.score on a scaleMEAN
SECONDARYForced Vital Capacity (FVC) Level at Week 24Week 24Analysis was performed on mITT population. Here, overall number of participants analyzed signifies participants with available data for this outcome measure.litersMEAN
SECONDARYPhysician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 24Week 24Analysis was performed on mITT population. Here, overall number of participants analyzed signifies participants with available data for this outcome measure.score on a scaleMEAN
SECONDARYPatient Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 24Week 24Analysis was performed on mITT population. Here, overall number of participants analyzed signifies participants with available data for this outcome measure.score on a scaleMEAN
SECONDARYScleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24Week 24Analysis was performed on mITT population. Here, overall number of participants analyzed signifies participants with available data for this outcome measure.score on a scaleMEAN
SECONDARYChange From Baseline in Modified Rodnan Skin Thickness Score (mRSS) at Weeks 8, 16, 36, and 52Baseline, Week 8, 16, 36 and 52Analysis was performed on mITT population. Here, number analyzed signifies participants with available data for each specified category.score on a scaleMEAN
SECONDARYChange From Baseline in Forced Vital Capacity (FVC) Level at Weeks 8, 16, 36, and 52Baseline, Week 8, 16, 36 and 52Analysis was performed on the mITT population. Here, number analyzed signifies participants with available data for each specified category.litersMEAN
SECONDARYChange From Baseline in Physician Global Assessment (Reported by the Physician) Quantified of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Weeks 8, 16, 36, and 52Baseline, Week 8, 16, 36 and 52Analysis was performed on the mITT population. Here, number analyzed signifies participants with available data for each specified category.score on a scaleMEAN
SECONDARYChange From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Weeks 8, 16, 36, and 52Baseline, Week 8, 16, 36 and 52Analysis was performed on the mITT population. Here, number analyzed signifies participants with available data for each specified category.score on a scaleMEAN
SECONDARYChange From Baseline in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Weeks 8, 16, 36, and 52Baseline, Week 8, 16, 36 and 52Analysis was performed on the mITT population. Here, number analyzed signifies participants with available data for each specified category.score on a scaleMEAN
SECONDARYNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)From first dose administration (i.e., Day 1) of study medication up to 28 days after last dose (i.e., up to 57.5 weeks)Analysis was performed on safety population which included all participants who received at least 1 dose of belumosudil 200 mg.ParticipantsCOUNT_OF_PARTICIPANTS

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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GET https://conductscience.org/api/trials/v1/NCT04680975/outcomes