Trial · NCT02688647
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy: Mean Changes in FVC From Baseline to Week 24 | 24 weeks | Analysis was performed using randomized population. Available data for change from baseline at Week 24 have been reported. | mL | MEAN |
| PRIMARY | Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24 | 24 weeks | Analysis was performed using randomized population. Available data for change from baseline at Week 24 have been reported. | % of predicted | MEAN |
| PRIMARY | Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC had the option of crossing over at 24 weeks. | All subjects treated in study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Percentages of Subjects With SAEs Related to Study Treatment | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC and crossing over also up to 24 weeks of BSC. | All subjects treated in study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil | Subjects who received belumosudil 400 mg PO QD were included. Subjects who only received BSC and did not cross over to treatment with belumosudil were not included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Percentages of Subjects With Deaths Related to Study Treatment | Up to 96 weeks (Weeks 24, 8, and 96) of treatment with belumosudil. Subjects randomized to BSC also had the option of crossing over to treatment with belumosudil at 24 weeks. | All subjects treated in study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- | 24 weeks | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | mL | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT | Up to 96 weeks (Weeks 24, 48, and 96) | All randomized subjects | mL | MEAN |
| SECONDARY | Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT | Up to 96 weeks (Weeks 24, 48, and 96) | All randomized subjects | Units | MEAN |
| SECONDARY | Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- | 24 weeks | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | % of predicted | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | All randomized subjects | meters | MEAN |
| SECONDARY | Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | All randomized subjects | % of diffusing capacity of CO | MEAN |
| SECONDARY | Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The mITT Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline FVC assessment. | score on a scale | MEAN |
| SECONDARY | Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | All randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 | Up to 96 Weeks (Weeks 24, 48, and 96) | All randomized subjects | units on a scale (0-100) | MEAN |
| SECONDARY | Efficacy: Event-free Probability of Acute Exacerbation of IPF | Up to 96 weeks (Weeks 24, 48, and 96) | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | Event-free Probability | NUMBER |
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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