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Trial · NCT05287126

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52Week 52
SecondaryPlasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)4 hours (± 15 minutes) post-dose
SecondaryPlasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod
pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
SecondaryProportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12Week 12
SecondaryProportion of Participants Achieving Endoscopic Improvement at Week 12Week 12
SecondaryProportion of Participants Achieving Endoscopic Improvement at Week 52Week 52
SecondaryProportion of Participants Achieving Symptomatic Remission at Week 12Week 12
SecondaryProportion of Participants Achieving Symptomatic Remission at Week 52Week 52
SecondaryProportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12Week 12
SecondaryProportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52Week 52
SecondaryProportion of Participants Achieving Clinical Response at Week 12Week 12
SecondaryProportion of Participants Achieving Clinical Response at Week 52Week 52
SecondaryProportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12Week 12
SecondaryProportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52Week 52
SecondaryProportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12Week 12
SecondaryProportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52Week 52
SecondaryNumber and Severity of Adverse EventsUp to Week 52Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

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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