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Trial · NCT03440372

Outcomes12

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARYPercent of Participants With Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARYPercent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARYPercent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARY
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12
At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARYPercent of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercent of ParticipantsNUMBER
SECONDARY
Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline and an SES-CD ≤ 4 Points and Decrease ≥ 2 Points at Week 12
At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARY
Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency Score no Worse Than Baseline and an SES-CD Decrease From Baseline of ≥ 50% at Week 12
At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARYHistologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARYPercent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARYPercent of Participants With Absence of Ulcers ≥ 0.5 cm With No Segment With Any Ulcerated Surface ≥ 10% at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER
SECONDARYPercent of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50% at Week 12At Week 12Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drugPercentage of ParticipantsNUMBER

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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