Clinical Trials in South Korea / NCT03950232
Active, not recruiting
Phase 3
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
NCT03950232 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Ulcerative Colitis
Investigational drug(s) / intervention(s)
Etrasimod: Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first
Study summary
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \[NCT03945188\] or APD334-302 \[NCT03996369\] or APD334-210 \[NCT04607837\]).
Eligibility
Inclusion Criteria:
* Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:
1. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
2. Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit
Exclusion Criteria:
* If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
* Experienced an adverse event that led to discontinuation from parent study
Primary outcome measure(s)
- Number and Severity of Safety Measures — Up to approximately 8 years
Safety as assessed by the evaluation of adverse events
Trial sites (470)
| Facility | City | Region | Status |
|---|---|---|---|
| Center for Digestive Health (Colonoscopy Location) | Dothan | Alabama | |
| Digestive Health Specialists (IP Address) | Dothan | Alabama | |
| Flowers Hospital (PFT Location) | Dothan | Alabama | |
| Pulmonary Associates (Secondary PFT Location) | Dothan | Alabama | |
| Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address) | Dothan | Alabama | |
| Inland Pulmonary Specialists [PFT Only] | Lake Elsinore | California | |
| A V Pediatrics,Allergy and Family Medicine | Lancaster | California | |
| Advanced Endoscopy and Pain Center(Colonoscopy) | Lancaster | California | |
| Antelope Valley Eye Care(Ophthalmologist) | Lancaster | California | |
| Jatinder S.Pruthi,MD FACG CPI | Lancaster | California | |
| Om Research LLC | Lancaster | California | |
| Renaissance Imaging Center(Chest X-Ray only) | Lancaster | California | |
| United Surgery Center Murrieta [Endoscopy Only] | Murrieta | California | |
| United Medical Doctors | Murrieta | California | |
| Advanced Imaging (Chest X-Ray) | Palmdale | California | |
| California Eye Professionals [OCT Only] | Temecula | California | |
| United Surgery Center Temecula [Endoscopy Only] | Temecula | California | |
| Front Range Endoscopy Center | Colorado Springs | Colorado | |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | |
| Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test) | Clearwater | Florida | |
| West Coast Endoscopy Center (Endoscopy Procedures) | Clearwater | Florida | |
| Northwood Vision- Optical Coherence Tomography (OCT) | Clearwater | Florida | |
| Northwood Vision-Optical Coherence Tomography-(OCT) | Clearwater | Florida | |
| Safety Harbor Surgery (Endoscopy Facility) | Clearwater | Florida | |
| Gastro Florida (Regulatory & Administrative Duties) | Clearwater | Florida | |
| Gastro Florida-(Regulatory & Administrative Duties) | Clearwater | Florida | |
| West Coast Endoscopy Center (Endoscopy Procedures) | Clearwater | Florida | |
| Dr Lee Shettle | Largo | Florida | |
| Florida Center for Gastroenterology | Largo | Florida | |
| Tampa Bay Regional Surgery Center | Largo | Florida | |
| NSB Research | New Smyrna Beach | Florida | |
| Tampa Bay Endoscopy Center (ENDO Only) | Tampa | Florida | |
| Tampa Bay Endoscopy Center | Tampa | Florida | |
| Lab - Processing / Storage | Tampa | Florida | |
| USF Health South Tampa Center for Advanced Healthcare | Tampa | Florida | |
| Pulmonary and Sleep of Tampa Bay (PFT Only) | Tampa | Florida | |
| GCP Clinical Research,LLC | Tampa | Florida | |
| LoCicero Medical Group (PFT Procedure Only) | Tampa | Florida | |
| Lyracore Health Alliance (PFT Procedure only) | Tampa | Florida | |
| Newsome Eye Specialist (OCT Procedures Only) | Tampa | Florida |
+ 430 more sites — see the full list on the official registry below.
More Pfizer trials in South Korea
Other trials for the same condition
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03950232 on ClinicalTrials.gov ↗ ← All trials in South Korea