An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Phase 3 – large-scale trial before approval
Conditions:
Ulcerative Colitis
Sponsor: Pfizer
trial.available_in:
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Overview
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 \[NCT04607837\]).
Who can participate
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
Locations
35
Argentina (1)
Centro de lnvestigation C.I .C.E. 9 de Julio
San Miguel de Tucumán , Tucumán Province
Australia (1)
Liverpool Hospital
Liverpool , New South Wales
Belarus (1)
Foreign Medical and Pharmaceutical Unitary Enterprise "Medical Center" Novoe Zrenie"
Grodno
Bulgaria (1)
"UMHAT "Kanev"" AD, Ruse
Rousse
Canada (1)
Mount Sinai Hospital
Toronto , Ontario
Chile (1)
Clinical Research Chile
Valdivia , Los Ríos Region
Croatia (1)
General Hospital Zadar
Zadar
Czech Republic (1)
Fakultni nemocnice u svate Anny v Brne
Brno
Denmark (1)
Aalborg University Hospital, department of medical gastroenterology,
Aalborg
Estonia (1)
Innomedica OÜ
Tallinn , Harju
France (1)
CHU Amiens Picardie
Amiens
Georgia (1)
LLC Todua Clinic
Tbilisi
Hungary (1)
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
Gyula , Bekes County
India (1)
Sids Hospital & Research Centre
Surat , Gujarat
Israel (1)
Bnai Zion Medical Center
Haifa
Italy (1)
I.R.C.C.S "Saverio De Bellis", Gastroenterologia II
Castellana Grotte , BARI
Japan (1)
Kojunkai Daido Clinic
Nagoya , Aichi-ken
Latvia (1)
P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center
Riga
Lebanon (1)
American University of Beirut Medical Center
Beirut
Lithuania (1)
Consultancy Polyclinic of Republican Panevezys Hospital
Panevezys
Mexico (1)
Centro de lnvestigacion Medico Biologica y Terapia Avanzada S.C.
Guadalajara , Jalisco
Moldova (1)
IMSP Institutul de Ftiziopneumologie "Chiril Draganiuc"
Chisinau
Poland (1)
NSZOZ Termedica - Centrum Badan Klinicznych
Poznan , Greater Poland Voivodeship
Romania (1)
SC Pelican lmpex SRL
Oradea , Bihor County
Russia (1)
LLC "Multidisciplinary Medical Clinic "Anturium"
Barnaul , Altayskiy Kray
Serbia (1)
Clinical Center " Dr Dragisa Misovic-Dedinje"
Belgrade
Slovakia (1)
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, II. Interna klinika SZU
Banská Bystrica
South Africa (1)
Johese Clinical Research: Midstream
Centurion , Gauteng
South Korea (1)
Yonsei University Wonju Severance Christian Hospital
Wŏnju , Gangwon-do
Spain (1)
HOSPITAL GENERAL UNIVERSITARIO de Alicante
Alicante , Valencia
Thailand (1)
Siriraj Hospital, Mahidol University
Bangkoknoi , Bangkok
Turkey (1)
Hacettepe University Medical Faculty
Ankara
Ukraine (1)
Communal Institution I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital, Department of
Dnipro
United Kingdom (1)
Yeovil District Hospital NHS Foundation Trust
Yeovil , Somerset
United States (1)
Center for Digestive Health (Colonoscopy Location)
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