Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

NCT01647516 | Completed Phase 2 Results DMC

• 1 other identifier: RPC01-202
• Study Type: interventional
• Target: 199
• Locations: 15 countries
• Sites: 88

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8

  Clinical Remission was defined as: Mayo score of \<2 points and with no individual subscore of \> 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. * Stool Frequency Subscore (SFS) * Rectal bleeding Subscore (RBS) * Endoscopy Subscore * Physician's Global Assessment (PGA) Clinical Remission was based on the 4-component Mayo definition.

  Week 8

Secondary Outcomes (9)

• Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8

  Week 8

• Change From Baseline in Mayo Score at Week 8

  Baseline to Week 8

• Percentage of Participants With Mucosal Healing at Week 8

  Week 8

• Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32

  Week 32

• Percentage of Participants Who Achieved Clinical Response at Week 32

  Week 32

Study Arms (3)

Ozanimod 0.5 mg

EXPERIMENTAL

Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.

Drug: Ozanimod

Ozanimod 1 mg

EXPERIMENTAL

Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.

Drug: Ozanimod

Placebo

PLACEBO COMPARATOR

Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period.

Drug: Placebo

Interventions

Ozanimod DRUG

Ozanimod capsules by mouth daily.

Also known as: Zeposia, RPC 1063

Ozanimod 0.5 mg; Ozanimod 1 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current use of anti-TNF agents

Sponsors & Collaborators

• Celgene: lead

Study Sites (88)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Alliance Clinical Research

Oceanside, California, 92056, United States

Location

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, 30342, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Endoscopic Microsurgery Associates

Towson, Maryland, 21204, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Universitair Ziekenhuis Leuven, Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Multiprofile Hospital for Active Treatment Kaspela

Plovdiv, 4000, Bulgaria

Location

University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

Sofia, 1407, Bulgaria

Location

UMHAT Sv Ivan Rilski EAD

Sofia, 1431, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

Sofia, 1527, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

Multiprofile Hospital for Active Treatment Doverie AD

Sofia, 1632, Bulgaria

Location

Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD

Sofia, 1712, Bulgaria

Location

Multiprofile Hospital for Active Treatment Sofiamed

Sofia, 1797, Bulgaria

Location

Multiprofile Hospital for Active Treatment Sveta Marina EAD

Varna, 9010, Bulgaria

Location

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Evaggelismos General Hospital

Athens, 106 76, Greece

Location

University Hospital of Ioannina

Ioannina, 45110, Greece

Location

University Hospital of Larissa

Larissa, 41110, Greece

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1062, Hungary

Location

Pannonia Maganorvosi Centrum

Budapest, 1136, Hungary

Location

Uzsoki Utcai Korhaz

Budapest, 1145, Hungary

Location

Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja

Debrecen, 4025, Hungary

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Carmel Medical Center

Haifa, 34362, Israel

Location

Wolfson Medical Center

Holon, 5822012, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Hadassah University Hospital

Jerusalem, 9112001, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, 3318 AT, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, 3083 AN, Netherlands

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

Hutt Valley District Health Board

Lower Hutt, 5010, New Zealand

Location

North Shore Hospital

Milford, 0620, New Zealand

Location

SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego

Bialystok, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej INTERMED

Częstochowa, 42-217, Poland

Location

Elblaski Szpital Specjalistyczny z Przychodnia

Elblag, 82-300, Poland

Location

Przychodnia Lekarska Nowy Chelm

Gdansk, 80-807, Poland

Location

Economicus - NZOZ ALL-MEDICUS

Katowice, 40-660, Poland

Location

Centrum Opieki Zdrowotnej Orkan Med

Ksawerów, 95-054, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

Lodz, 90-302, Poland

Location

Instytut Medycyny Wsi

Lublin, 20-090, Poland

Location

MEDICOR Centrum Medyczne

Rzeszów, 35-068, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej Triclinium

Warsaw, 02-797, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

Warsaw, 03-580, Poland

Location

LexMedica Osrodek Badan Klinicznych

Wroclaw, 53-114, Poland

Location

Regional Clinical Hospital

Krasnoyarsk, 660022, Russia

Location

SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF

Moscow, 119991, Russia

Location

Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

Nizhny Novgorod, 603126, Russia

Location

Novosibirsk State Medical University

Novosibirsk, 630084, Russia

Location

SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF

Omsk, 644043, Russia

Location

SEIHPE Rostov State Medical University of MoH of RF

Rostov-on-Don, 344022, Russia

Location

Russian Medical Military Academy na SMKirov

Saint Petersburg, 191163, Russia

Location

City Hospital 26

Saint Petersburg, 196247, Russia

Location

Medical Company Hepatolog

Samara, 443000, Russia

Location

Slovak Research Center

Ilava, 01901, Slovakia

Location

Specializovana Nemocnica Svorada Zobor

Nitra, 94901, Slovakia

Location

GASTRO I., s.r.o.

Prešov, 080 01, Slovakia

Location

Yeungnam University Medical Center

Daegu, 705717, South Korea

Location

Konyang University Hospital

Daejeon, 302718, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, 110746, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Kyunghee University Medical Center

Seoul, 130702, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

The Catholic University of Korea, St.Vicent's Hospital

Suwon, 442723, South Korea

Location

Wonju Christian Hospital

Wŏnju, 220701, South Korea

Location

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, 76008, Ukraine

Location

Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU

Ivano-Frankivsk, 76014, Ukraine

Location

Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine

Kharkiv, 61039, Ukraine

Location

Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE

Kyiv, 04201, Ukraine

Location

Order of the Red Star MMMCC MMCH Clinic of Gastroenterology

Kyiv, 1133, Ukraine

Location

CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

Kyiv, 2232, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, 79010, Ukraine

Location

Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

Lviv, 79059, Ukraine

Location

Vinnytsia Regional Clinical

Vinnytsia, 21018, Ukraine

Location

Medical Clinical Research Center "Health Clinic"

Vinnytsia, 21029, Ukraine

Location

Municipal Institution Zaporizhzhia

Zaporizhzhia, 69600, Ukraine

Location

Zaporizhzhya city multidisciplinary clinical hospital #9

Zaporizhzhya, 69065, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 27144850 BACKGROUND

• Regueiro M, Siegmund B, Horst S, Moslin R, Charles L, Petersen A, Tatosian D, Wu H, Lawlor G, Fischer M, D'Haens G, Colombel JF. Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis. Inflamm Bowel Dis. 2025 Apr 10;31(4):1010-1017. doi: 10.1093/ibd/izae136.

  PMID: 39018016 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Anne McClain, Senior Manager
• Organization: Celgene Corporation

ClinicalTrialDisclosure@Celgene.com

908-673-9100

Study Officials

• AnnKatrin Petersen, MD

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 23, 2012
• Study Start: December 26, 2012
• Primary Completion: March 10, 2015
• Study Completion: August 30, 2019
• Last Updated: May 19, 2021
• Results First Posted: October 14, 2020

Record last verified: 2021-05

Locations

NZ (5); RU (9); CA (1); IL (6); UA (12); KR (9); HU (4); US (10); GR (3); BU (9); AU (1); BE (1); NL (3); PL (12); SL (3)