Etrasimod Arginine Blue
Sponsors
Arena Pharmaceuticals Inc., Pfizer Inc., Pfizer Inc., Pfizer Inc.
Conditions
Crohn's DiseaseModerately to severely active ulcerative colitisUlcerative ColitisUlcerative Colitis and immune-mediated inflammatory disordersalopecia areataand
eosinophilic esophagitisatopic dermatitisimmune-mediated inflammatory disorders
Phase 1
C5041034 - A Phase 1, Open-Label, Randomized, Single Dose, Crossover Study to Estimate the Relative Bioavailability of Etrasimod (PF-07915503) Mini Tablets in Water and 3 Food Vehicles Compared to the Etrasimod (PF-07915503) Clinical IR Tablets Under Fasted Conditions, and to Evaluate Mini Tablet Palatability in Healthy Adult Participants
CompletedCTIS2023-504411-32-00
Start: 2023-08-23End: 2024-01-04Target: 16Updated: 2023-08-02
C5041053 - A PHASE 1 MULTIPLE-DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ETRASIMOD IN HEALTHY LACTATING WOMEN
RecruitingCTIS2025-520930-44-00
Start: 2025-07-18Target: 8Updated: 2025-07-09
Phase 2
C5041010 (APD334-207) An Open Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants with Moderately to Severely Active Ulcerative Colitis
RecruitingCTIS2022-500345-25-00
Start: 2023-01-16Target: 19Updated: 2025-07-28
C5041006 (APD334 202 or APD334-202EU): 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
CompletedCTIS2024-513569-38-00
Start: 2021-07-09End: 2025-01-22Target: 367Updated: 2025-05-07
C5041018 - A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis
Not yet recruitingCTIS2025-523100-77-00
Target: 1Updated: 2026-02-27