A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Abstract
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.
Conditions: Crohn's Disease.
Primary outcome: Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA; Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1; Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort; Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Non-Responder Cohort; Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Responder Cohort; Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Non-Responder Cohort.
Enrollment: 379 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 379 participants or records.
Read the paper
Related studies
- The potential and limitations of neutrons, electrons and X-rays for atomic resolution microscopy of unstained biological molecules
- X-ray-Computed Tomography Contrast Agents
- Reactivity of Surface Species in Heterogeneous Catalysts Probed by In Situ X-ray Absorption Techniques
- Single-crystal X-ray diffraction studies on structural transformations of porous coordination polymers
- Investigation of solid/vapor interfaces using ambient pressure X-ray photoelectron spectroscopy
- Resonant X-Ray Scattering Studies of Charge Order in Cuprates
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.