Trial · NCT03919799
Outcomes71
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 71
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DB Period: Number of Participants With Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) Score Greater Than or Equal to (>=) 60 Percent (%) at Week 24 | Week 24 | Analysis was performed on mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 24 | Week 24 | Analysis was performed on mITT population. LOCF method was used to handle missing data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52 | Week 52 | Analysis was performed on mITT population. | score on a scale | MEAN |
| SECONDARY | DB Period: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | percent predicted FVC | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Percentage Improvement in Modified Rodnan Skin Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | percentage improvement | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Percentage Improvement in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | percentage improvement | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Percentage Improvement in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | percentage improvement | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Percentage Improvement in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. | percentage improvement | LEAST_SQUARES_MEAN |
| SECONDARY | OLE Period: Change From Baseline in Modified Rodnan Skin Score at Week 52 | Baseline, Week 52 | Analyzed on mITT. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. | score on a scale | MEAN |
| SECONDARY | OLE Period: Change From Baseline in Percent Predicted Forced Vital Capacity at Week 52 | Baseline, Week 52 | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. | percent predicted FVC | MEAN |
| SECONDARY | OLE Period: Change From Baseline in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 52 | Baseline, Week 52 | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. | score on a scale | MEAN |
| SECONDARY | OLE Period: Change From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 52 | Baseline, Week 52 | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. | score on a scale | MEAN |
| SECONDARY | OLE Period: Change From Baseline in Scleroderma Health Assessment Questionnaire-Disability Index Total Score at Week 52 | Baseline, Week 52 | Analyzed on mITT. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. | score on a scale | MEAN |
| SECONDARY | OLE Period: Percentage Improvement in Modified Rodnan Skin Score at Week 52 | Baseline, Week 52 | Analyzed on mITT. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. | percentage improvement | MEAN |
| SECONDARY | OLE Period: Percentage Improvement Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 52 | Baseline, Week 52 | Analyzed on mITT. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. | percentage improvement | MEAN |
| SECONDARY | OLE Period: Percentage Improvement in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 52 | Baseline, Week 52 | Analyzed on mITT. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. | percentage improvement | MEAN |
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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