Fact CheckerSign in

NCT02531126CompletedPhase 3

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC)

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jan 2025

Brief summary (registry, in English)

1. To evaluate the long-term safety and efficacy of RPC1063 for the treatment of all patients with moderate to severe UC 2. To evaluate the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
223 (actual)
First submitted
19 Jul 2024
Start date
16 Jul 2015
Lead sponsor
Celgene International II SARL
NCT number
NCT02531126
EU CT number
2024-514815-92-00
EudraCT number
2015-001600-64

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 223
  • 24 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving treatment with breast cancer resistance protein inhibitors

Other illness

  • Clinically relevant cardiovascular conditions
  • Liver function impairment
    • Other protocol-defined inclusion/exclusion criteria apply

Who the study is looking for

  • Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial

Criteria the registry did not label

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (52)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
CamperdownAustraliaUnknown status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumCompleted
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
Acibadem City Clinic Diagnostic And Consultation Center Ltd.
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
Medical Center Medica Plus Ltd.
Coordinator of this site? Confirm its status
Veliko TirnovoBulgariaCompleted
-
Coordinator of this site? Confirm its status
VitebskBelarusUnknown status
-
Coordinator of this site? Confirm its status
LindsayCanadaUnknown status
GASTRO JeKa s.r.o.
Coordinator of this site? Confirm its status
Klatovy IVCzechiaCompleted
Institute for Clinical and Experimental Medicine
Coordinator of this site? Confirm its status
PragueCzechiaCompleted
Nemocnice Slany
Coordinator of this site? Confirm its status
SlanýCzechiaCompleted
-
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
-
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
-
Coordinator of this site? Confirm its status
FrankfurtGermanyUnknown status
-
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
AthensGreeceUnknown status
-
Coordinator of this site? Confirm its status
OsijekCroatiaUnknown status
Clinfan Kft.
Coordinator of this site? Confirm its status
SzekszardHungaryCompleted
-
Coordinator of this site? Confirm its status
RehovotIsraelUnknown status
ASST Fatebenefratelli Sacco
Coordinator of this site? Confirm its status
MilanItalyCompleted
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
RozzanoItalyCompleted
-
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
WŏnjuSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
ChisinauMoldovaUnknown status
-
Coordinator of this site? Confirm its status
ChisinauMoldovaUnknown status
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
Coordinator of this site? Confirm its status
BydgoszczPolandCompleted
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Coordinator of this site? Confirm its status
CracowPolandCompleted
Globe Badania Kliniczne Sp. z o.o.
Coordinator of this site? Confirm its status
KlodzkoPolandCompleted
Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.
Coordinator of this site? Confirm its status
KsawerówPolandCompleted
Velocity Nova Sp. z o.o.
Coordinator of this site? Confirm its status
LublinPolandCompleted
Specjalistyczna Praktyka Lekarska dr med. Marek Horyński
Coordinator of this site? Confirm its status
SopotPolandCompleted
GASTROMED Sp. z o.o.
Coordinator of this site? Confirm its status
TorunPolandCompleted
Eb Group Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Spitalul Județean de Urgență Bacău
Coordinator of this site? Confirm its status
BacauRomaniaCompleted
Spitalul Universitar de Urgență București
Coordinator of this site? Confirm its status
BucharestRomaniaCompleted
Memorial Healthcare International S R L
Coordinator of this site? Confirm its status
BucharestRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Coordinator of this site? Confirm its status
TimisoaraRomaniaCompleted
-
Coordinator of this site? Confirm its status
BardejovSlovakiaUnknown status
-
Coordinator of this site? Confirm its status
KharkivUkraineUnknown status
-
Coordinator of this site? Confirm its status
VinnytsiaUkraineUnknown status
-
Coordinator of this site? Confirm its status
AnaheimUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Baton RougeUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
GermantownUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Mission HillsUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Oak LawnUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.