Trial · NCT05470985
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| PRIMARY | Percentage of Participants Achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 2 or SES-CD ≤ 4 Points With no SES-CD Subscore > 1 Point at Week 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10 at Week 12 Based on Data as Observed | Week 12 | The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed Week 12 visit were only included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% (ER-50) at Week 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% (ER-50) at Week 12 Based on Data as Observed | Week 12 | The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Only participants who completed week 12 visit are included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score ≥ 12.5 and a Total PCDAI Score of < 30 Points at Week 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score ≥ 12.5 and a Total PCDAI Score of < 30 Points at Week 12 Based on Data as Observed | Week 12 | The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed Week 12 visit were only included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Adolescents Who Achieve an Average Daily Abdominal Pain Score ≤ 1 Point and an Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12 Based on Data as Observed | Week 12 | The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed Week 12 visit were only included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Adolescents Who Achieve an Average Daily Abdominal Pain Score ≤ 1 Point and an Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 64 | Week 64 | Data was not collected as no participants in the study completed Week 64 visit. | ||
| SECONDARY | Change From Baseline in Stool Frequency (SF) Score at Week 64 | Baseline and Week 64 | Data was not collected as no participants completed Week 64 visit. Pre-specified to assess change at Week 64. | ||
| SECONDARY | Change From Baseline in Abdominal Pain (AP) Score at Week 64 | Baseline and Week 64 | Data was not collected as no participants completed Week 64 visit. Pre-specified to assess change at Week 64. | ||
| SECONDARY | Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 Based on Data as Observed | Week 12 | The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed week 12 visit were included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12 Based on Data as Observed | Week 12 | The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed week 12 visit were included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve a Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Adolescents Who Achieve a Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Participants Who Achieve a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Participants Achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 2 or SES-CD ≤ 4 Points With no SES-CD Subscore > 1 Point at Week 12 Based on Data as Observed | Week 12 | The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed week 12 visit were included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit. | percentage of participants | NUMBER |
| SECONDARY | Steady State Systemic Exposures of Ozanimod at Week 20 and Throughout the Study | Week 20 and up to end of study (Week 64) | Data was not collected as no participants completed Week 64 visit. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05470985/outcomes