Clinical trial NCT01647516: Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-07-23
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis (UC) confirmed on endoscopy
* Moderately to severely active UC (Mayo score 6-12)

Exclusion Criteria:

* Current use of anti-TNF agents

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
timeFrame: Week 8
measure: Change From Baseline in Mayo Score at Week 8
timeFrame: Baseline to Week 8
measure: Percentage of Participants With Mucosal Healing at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
timeFrame: Week 32
measure: Percentage of Participants Who Achieved Clinical Response at Week 32
timeFrame: Week 32
measure: Percentage of Participants With Mucosal Healing at Week 32
timeFrame: Week 32
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
timeFrame: From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
timeFrame: From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.
measure: Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
timeFrame: From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Oceanside
country: United States
facility: Alliance Clinical Research
state: California
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Towson
country: United States
facility: Endoscopic Microsurgery Associates
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Kaspela
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
city: Sofia
country: Bulgaria
facility: UMHAT Sv Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Doverie AD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sofiamed
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sveta Marina EAD
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Athens
country: Greece
facility: Evaggelismos General Hospital
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Debrecen
country: Hungary
facility: Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejon
country: Korea, Republic of
facility: Konyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St.Vicent's Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Lower Hutt
country: New Zealand
facility: Hutt Valley District Health Board
city: Milford
country: New Zealand
facility: North Shore Hospital
city: Bialystok
country: Poland
facility: SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
city: Czestochowa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej INTERMED
city: Elblag
country: Poland
facility: Elblaski Szpital Specjalistyczny z Przychodnia
city: Gdansk
country: Poland
facility: Przychodnia Lekarska Nowy Chelm
city: Katowice
country: Poland
facility: Economicus - NZOZ ALL-MEDICUS
city: Ksawerow
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan Med
city: Lodz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
city: Lublin
country: Poland
facility: Instytut Medycyny Wsi
city: Rzeszow
country: Poland
facility: MEDICOR Centrum Medyczne
city: Warsaw
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Triclinium
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Krasnoyarsk
country: Russian Federation
facility: Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Omsk
country: Russian Federation
facility: SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
city: Rostov on Don
country: Russian Federation
facility: SEIHPE Rostov State Medical University of MoH of RF
city: Saint Petersburg
country: Russian Federation
facility: Russian Medical Military Academy na SMKirov
city: Saint Petersburg
country: Russian Federation
facility: City Hospital 26
city: Samara
country: Russian Federation
facility: Medical Company Hepatolog
city: Ilava
country: Slovakia
facility: Slovak Research Center
city: Nitra
country: Slovakia
facility: Specializovana Nemocnica Svorada Zobor
city: Presov
country: Slovakia
facility: GASTRO I., s.r.o.
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
city: Kharkiv
country: Ukraine
facility: Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
city: Kyiv
country: Ukraine
facility: Order of the Red Star MMMCC MMCH Clinic of Gastroenterology
city: Kyiv
country: Ukraine
facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical
city: Vinnytsya
country: Ukraine
facility: Medical Clinical Research Center "Health Clinic"
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution Zaporizhzhia
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya city multidisciplinary clinical hospital #9
Study officials:
affiliation: Bristol-Myers Squibb
name: AnnKatrin Petersen, MD
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Feagan BG, Wolf DC, D'Haens G, Vermeire S, Hanauer SB, Ghosh S, Smith H, Cravets M, Frohna PA, Aranda R, Gujrathi S, Olson A; TOUCHSTONE Study Group. Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis. N Engl J Med. 2016 May 5;374(18):1754-62. doi: 10.1056/NEJMoa1513248.