Ulcerative ColitisPhase 2TouchstoneNCT01647516
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
A Phase 2 study testing Ozanimod in people with Ulcerative Colitis, run by Celgene at 88 sites in 15 countries.
Trial summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Ozanimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 88 sitesin 15 countries
- Study dates
- 26 Dec 2012to 30 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcerative colitis (UC) confirmed on endoscopy
- Moderately to severely active UC (Mayo score 6-12)
Who cannot join
- Current use of anti-TNF agents
Trial locations and contacts
88 sites in 15 countries.
88 sites in 15 countries
Poland12 sites
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
Bialystok
Niepubliczny Zaklad Opieki Zdrowotnej INTERMED
Częstochowa, 42-217
Elblaski Szpital Specjalistyczny z Przychodnia
Elblag, 82-300
Przychodnia Lekarska Nowy Chelm
Gdansk, 80-807
Economicus - NZOZ ALL-MEDICUS
Katowice, 40-660
Centrum Opieki Zdrowotnej Orkan Med
Ksawerów, 95-054
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
Lodz, 90-302
Instytut Medycyny Wsi
Lublin, 20-090
MEDICOR Centrum Medyczne
Rzeszów, 35-068
Niepubliczny Zaklad Opieki Zdrowotnej Triclinium
Warsaw, 02-797
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
Warsaw, 03-580
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114
Ukraine12 sites
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008
Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76014
Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine
Kharkiv, 61039
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
Kyiv, 04201
Order of the Red Star MMMCC MMCH Clinic of Gastroenterology
Kyiv, 1133
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
Kyiv, 2232
Lviv Regional Clinical Hospital
Lviv, 79010
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv, 79059
Vinnytsia Regional Clinical
Vinnytsia, 21018
Medical Clinical Research Center "Health Clinic"
Vinnytsia, 21029
Zaporizhzhya city multidisciplinary clinical hospital #9
Zaporizhzhya, 69065
Municipal Institution Zaporizhzhia
Zaporizhzhya, 69600
United States10 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, 30342
University of North Carolina
Chapel Hill, North Carolina, 27599
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Long Island Clinical Research Associates
Great Neck, New York, 11021
University of California San Diego
La Jolla, California, 92037
Alliance Clinical Research
Oceanside, California, 92056
Endoscopic Microsurgery Associates
Towson, Maryland, 21204
Bulgaria9 sites
Multiprofile Hospital for Active Treatment Kaspela
Plovdiv, 4000
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
Sofia, 1407
UMHAT Sv Ivan Rilski EAD
Sofia, 1431
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
Sofia, 1527
Military Medical Academy
Sofia, 1606
Multiprofile Hospital for Active Treatment Doverie AD
Sofia, 1632
Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD
Sofia, 1712
Multiprofile Hospital for Active Treatment Sofiamed
Sofia, 1797
Multiprofile Hospital for Active Treatment Sveta Marina EAD
Varna, 9010
Russia9 sites
Regional Clinical Hospital
Krasnoyarsk, 660022
SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF
Moscow, 119991
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, 603126
Novosibirsk State Medical University
Novosibirsk, 630084
SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
Omsk, 644043
SEIHPE Rostov State Medical University of MoH of RF
Rostov-on-Don, 344022
Russian Medical Military Academy na SMKirov
Saint Petersburg, 191163
City Hospital 26
Saint Petersburg, 196247
Medical Company Hepatolog
Samara, 443000
South Korea9 sites
Yeungnam University Medical Center
Daegu, 705717
Konyang University Hospital
Daejeon, 302718
Asan Medical Center
Seoul, 05505
Kangbuk Samsung Medical Center
Seoul, 110746
Severance Hospital, Yonsei University Health System
Seoul, 120-752
Kyunghee University Medical Center
Seoul, 130702
Ewha Womans University Mokdong Hospital
Seoul, 158-710
The Catholic University of Korea, St.Vicent's Hospital
Suwon, 442723
Wonju Christian Hospital
Wŏnju, 220701
Israel6 sites
Barzilai Medical Center
Ashkelon, 7830604
Carmel Medical Center
Haifa, 34362
Wolfson Medical Center
Holon, 5822012
Shaare Zedek Medical Center
Jerusalem, 91031
Hadassah University Hospital
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 44281
New Zealand5 sites
Christchurch Hospital
Christchurch, 8011
Dunedin Hospital
Dunedin, 9016
Waikato Hospital
Hamilton, 3204
Hutt Valley District Health Board
Lower Hutt, 5010
North Shore Hospital
Milford, 0620
Hungary4 sites
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062
Pannonia Maganorvosi Centrum
Budapest, 1136
Uzsoki Utcai Korhaz
Budapest, 1145
Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
Debrecen, 4025
Greece3 sites
Evaggelismos General Hospital
Athens, 106 76
University Hospital of Ioannina
Ioannina, 45110
University Hospital of Larissa
Larissa, 41110
Netherlands3 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT
Ikazia Ziekenhuis
Rotterdam, 3083 AN
Slovakia3 sites
Slovak Research Center
Ilava, 01901
Specializovana Nemocnica Svorada Zobor
Nitra, 94901
GASTRO I., s.r.o.
Prešov, 080 01
Belgium1 site
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven, 3000
Canada1 site
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
About this study
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
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis
- Being tested
- Ozanimod, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Also called Zeposia, RPC 1063
Ozanimod capsules by mouth daily.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ozanimod |
| Placebo | Placebo comparator | Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (9)
Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding 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.
Clinical Respone was based on the 4-component Mayo definition.
Measured: Week 8
Change From Baseline in Mayo Score at Week 8
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)
Measured: Baseline to Week 8
Percentage of Participants With Mucosal Healing at Week 8
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.
The endoscopy scale:
0 = Normal or inactive disease
- = Mild disease (erythema, decreased vascular pattern, mild friability)
- = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)
- = Severe disease (spontaneous bleeding, ulceration)
Measured: Week 8
Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
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 score 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)
Measured: Week 32
Percentage of Participants Who Achieved Clinical Response at Week 32
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding 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)
Measured: Week 32
Percentage of Participants With Mucosal Healing at Week 32
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.
The endoscopy scale:
0 = Normal or inactive disease
- = Mild disease (erythema, decreased vascular pattern, mild friability)
- = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)
- = Severe disease (spontaneous bleeding, ulceration)
Measured: Week 32
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Measured: 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
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Measured: 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.
Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study start26 Dec 2012
- Primary completion10 Mar 2015
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AnnKatrin Petersen, MD, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647516
- Sponsor's protocol ID
- RPC01-202
- Acronym
- Touchstone
- Status last verified
- May 2021
- First submitted
- 19 Jul 2012
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27144850Rubin DT, Danese S, Nakase H, Ungaro RC, Wolf DC, Alekseeva O, Petersen A, Liu Z, Mehra D, Jain A, Osterman MT, Krakovich A, Riolo JV, DeBoer E, Appio J, Sinh P, Cree BAC, Cohen JA, Irving P. Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis. Inflamm Bowel Dis. 2026 May 1;32(5):954-962. doi: 10.1093/ibd/izaf319.
PubMed 41677183Regueiro 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.
PubMed 39018016
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01647516
- Acronym / sponsor ID
- Touchstone / RPC01-202
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2012 (actual)
- Primary completion
- 10 Mar 2015 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozanimod 0.5 mg | Experimental | Drug: OzanimodParticipants 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. |
| Ozanimod 1 mg | Experimental | Drug: OzanimodParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboIdentically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period. |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ulcerative colitis (UC) confirmed on endoscopy
- Moderately to severely active UC (Mayo score 6-12)
Key exclusion criteria (1 listed)
- Current use of anti-TNF agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodAlso: Zeposia, RPC 1063Ozanimod capsules by mouth daily. | Drug | Ozanimod 0.5 mg, Ozanimod 1 mg |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
Time frame: 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.
9 secondary outcomes
Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Time frame: Week 8
Change From Baseline in Mayo Score at Week 8
Time frame: Baseline to Week 8
Percentage of Participants With Mucosal Healing at Week 8
Time frame: Week 8
Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
Time frame: Week 32
Percentage of Participants Who Achieved Clinical Response at Week 32
Time frame: Week 32
Percentage of Participants With Mucosal Healing at Week 32
Time frame: Week 32
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
Time frame: 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
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
Time frame: 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.
Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27144850Sandborn 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.
- Derived from this study: PubMed 41677183Rubin DT, Danese S, Nakase H, Ungaro RC, Wolf DC, Alekseeva O, Petersen A, Liu Z, Mehra D, Jain A, Osterman MT, Krakovich A, Riolo JV, DeBoer E, Appio J, Sinh P, Cree BAC, Cohen JA, Irving P. Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis. Inflamm Bowel Dis. 2026 May 1;32(5):954-962. doi: 10.1093/ibd/izaf319.
- Derived from this study: PubMed 39018016Regueiro 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.
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An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AnnKatrin Petersen, MD study director
Bristol-Myers Squibb
88 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ozanimod in people with Ulcerative Colitis, run by Celgene at 88 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in Poland, Ukraine, United States, Bulgaria, Russia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647516, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.