Ulcerative ColitisPhase 3NCT02531126
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
A Phase 3 study testing RPC1063 in people with Ulcerative Colitis, run by Celgene at 41 sites in 20 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- RPC1063
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 877 participants
- Where
- 41 sitesin 20 countries
- Study dates
- 2 Dec 2015to 19 Dec 2024
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Who cannot join
- Receiving treatment with breast cancer resistance protein inhibitors
- Clinically relevant cardiovascular conditions
- Liver function impairment
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
41 sites in 20 countries.
41 sites in 20 countries
United States10 sites
Local Institution - 102
Anaheim, California, 92801
Local Institution - 119
Baton Rouge, Louisiana, 70809
Local Institution - 122
Dallas, Texas, 75246
Local Institution - 179
Germantown, Tennessee, 38138
Local Institution - 127
Jacksonville, North Carolina, 28546
Local Institution - 117
Mission Hills, California, 91345
Local Institution - 112
Oak Lawn, Illinois, 60453
Local Institution - 290
Oklahoma City, Oklahoma, 73112
Local Institution - 143
Portland, Oregon, 97239
Local Institution - 144
Tucson, Arizona, 85712
Bulgaria3 sites
Local Institution - 450
Sofia, 1233
Local Institution - 459
Sofia, 1336
Local Institution - 451
Sofia, 1606
Germany3 sites
Local Institution - 535
Berlin, 12200
Local Institution - 525
Berlin, 13353
Local Institution - 545
Frankfurt, 60594
Belgium2 sites
Local Institution - 600
Ghent, 9000
Local Institution - 601
Leuven, 3000
Czechia2 sites
Local Institution - 342
Klatovy, 399 01
Local Institution - 337
Prague, 14021
Hungary2 sites
Local Institution - 816
Balatonfüred, 8230
Local Institution - 808
Debrecen, 4032
Moldova2 sites
Local Institution - 658
Chisinau, MD-2068
Local Institution - 659
Chisinau, MD2025
Romania2 sites
Local Institution - 677
Bucharest, 010719
Local Institution - 673
Bucharest, 050098
South Korea2 sites
Local Institution - 364
Seongnam-si, 13620
Local Institution - 354
Wŏnju, 26426
Ukraine2 sites
Local Institution - 954
Kharkiv, 61039
Local Institution - 957
Vinnytsia, 21018
United Kingdom2 sites
Local Institution - 236
London, GREATER LONDON, E11 1NR
Local Institution - 243
London, SE1 9RT
About this study
Official title: A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.
Read the detailed description
This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.
- Conditions
- Ulcerative Colitis
- Being tested
- RPC1063
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPC1063Drug
Also called Ozanimod
| Study group | Role | What they receive |
|---|---|---|
| RPC0163 (Ozanimod) | Experimental | Not described Receives: Drug: RPC1063 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.
Measured: From first dose to 90 days post last dose (Up to approximately 92 months)
Secondary outcomes (12)
Percentage of Participants With Clinical Remission
Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore <=1 (and a decrease of >=1 point from the baseline stool frequency subscore); and endoscopy subscore <=1.
Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).
Measured: Week 46, 94, 142, 190, 238
Percentage of Participants With Clinical Response
Clinical response is defined as reduction from baseline in the 9-point Mayo score of >=2 points and reduction from baseline in the 9-point Mayo score >=35%, and (reduction from baseline in the rectal bleeding subscore of >=1 point or a rectal bleeding subscore of <=1 point). 9 point Mayo score is defined as the sum of rectal bleeding subscore, stool frequency subscore, and the endoscopy subscore each ranging from (0=normal activity-3=worse activity) for a total score that ranges from 0 to 9 with higher score indicating worsening symptoms.
Measured: Week 46, 94, 142, 190, 238
Percentage of Participants With Endoscopic Improvement
Endoscopic Improvement is defined as endoscopy subscore of <=1 point. 0 = Normal or inactive disease;
- = Mild disease (erythema, decreased vascular pattern, does not include friability)
- = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)
- = Severe disease (spontaneous bleeding, ulceration)
Measured: Week 46, 94, 142, 190, 238
Percentage of Participants With Corticosteroid-free Remission
Corticosteroid-free remission is defined as clinical remission while off corticosteroids for ≥12 weeks. Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore <=1 (and a decrease of >=1 point from the baseline stool frequency subscore); and endoscopy subscore <=1.
Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).
Measured: Week 46, 94, 142, 190, 238
Percentage of Participants With Histologic Remission
Histologic remission is defined as Geboes index score < 2.0. The Geboes score is a validated histological grading system for UC that ranges from 0=no disease activity to 5=high disease activity.
Measured: Week 46, 94, 142, 190, 238
Percentage of Participants With Mucosal Healing
Mucosal Healing is defined as Endoscopy subscore of ≤ 1 point (0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability)) and a Geboes index score < 2.0 (The Geboes score is a validated histological grading system for UC that ranges from 0=no disease activity to 5=high disease activity.)
Measured: Week 46, 94, 142, 190, 238
Change From Baseline in Complete Mayo Score
The Complete Mayo Score is a composite of four assessments, each rated from 0 to 3:
- Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal)
- Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes)
- endoscopy (0 = Normal or inactive disease; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease)
- Physician's Global Assessment (0 = Normal; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease).
The total score range is from 0-12, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.
Measured: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Change From Baseline in Partial Mayo Score
The Partial Mayo Score is a composite of three assessments, each rated from 0 to 3:
- Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal)
- Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes)
- Physician's Global Assessment (0 = Normal; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease).
The total score range is from 0-9, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.
Measured: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Change From Baseline in 9-Point Mayo Score
The 9-point Mayo Score is a composite of three assessments, each rated from 0 to 3:
- Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal)
- Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes)
- Endoscopy (0 = Normal or inactive disease; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease) The total score range is from 0-9, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.
Measured: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission
Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore <=1 (and a decrease of >=1 point from the baseline stool frequency subscore); and endoscopy subscore <=1.
Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).
Measured: Week 46, 94, 142, 190, 238
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response
Clinical response is defined as reduction from baseline in the 9-point Mayo score of >=2 points and reduction from baseline in the 9-point Mayo score >=35%, and (reduction from baseline in the rectal bleeding subscore of >=1 point or a rectal bleeding subscore of <=1 point). 9 point Mayo score is defined as the sum of rectal bleeding subscore, stool frequency subscore, and the endoscopy subscore each ranging from (0=normal activity-3=worse activity) for a total score that ranges from 0 to 9 with higher score indicating worsening symptoms.
Measured: Week 46, 94, 142, 190, 238
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement
Endoscopic Improvement is defined as endoscopy subscore of <=1 point. 0 = Normal or inactive disease;
1 = Mild disease (erythema, decreased vascular pattern, does not include friability)
Measured: Week 46, 94, 142, 190, 238
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study start2 Dec 2015
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
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 (6)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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 877 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531126
- Sponsor's protocol ID
- RPC01-3102
- Other IDs
- 2015-001600-64, U1111-1218-0284, 2015
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2015
- Last updated
- 31 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yarur A, Irving P, Siegmund B, Dubinsky MC, Ananthakrishnan AN, Regueiro M, Ungaro RC, Ritter T, Nakase H, Liu Z, Mehra D, Osterman MT, Jain A, Rubin DT, Hibi T. Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid. Inflamm Bowel Dis. 2026 Jan 1;32(1):77-86. doi: 10.1093/ibd/izaf195.
PubMed 41003640Sands BE, Rubin DT, Loftus EV Jr, Wolf DC, Panaccione R, Colombel JF, Dignass A, Regueiro M, Vermeire S, Afzali A, Lawlor G, Ahmad HA, Wu H, Osterman MT, Jain A, D'Haens G. Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial. Am J Gastroenterol. 2025 Oct 1;120(10):2339-2349. doi: 10.14309/ajg.0000000000003310. Epub 2025 Jan 8.
PubMed 39773524Regueiro 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 39018016Sands BE, D'Haens G, Panaccione R, Regueiro M, Ghosh S, Hudesman D, Ahmad HA, Mehra D, Wu H, Jain A, Petersen A, Osterman MT, Afzali A, Danese S. Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2084-2095.e4. doi: 10.1016/j.cgh.2024.03.042. Epub 2024 May 8.
PubMed 38723981Armuzzi A, Cross RK, Lichtenstein GR, Hou J, Deepak P, Regueiro M, Wolf DC, Akukwe L, Ahmad HA, Jain A, Kozinn M, Wu H, Petersen A, Charles L, Long M. Cardiovascular Safety of Ozanimod in Patients With Ulcerative Colitis: True North and Open-Label Extension Analyses. Clin Gastroenterol Hepatol. 2024 May;22(5):1067-1076.e3. doi: 10.1016/j.cgh.2023.11.018. Epub 2023 Nov 30.
PubMed 38040274Sandborn WJ, Feagan BG, Hanauer S, Vermeire S, Ghosh S, Liu WJ, Petersen A, Charles L, Huang V, Usiskin K, Wolf DC, D'Haens G. Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study. J Crohns Colitis. 2021 Jul 5;15(7):1120-1129. doi: 10.1093/ecco-jcc/jjab012.
PubMed 33438008
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02531126
- Acronym / sponsor ID
- RPC01-3102
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 877 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Posted 31 Dec 2025
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 evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.
Detailed description
This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RPC0163 (Ozanimod) | Experimental | Drug: RPC1063 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Key exclusion criteria (4 listed)
- Receiving treatment with breast cancer resistance protein inhibitors
- Clinically relevant cardiovascular conditions
- Liver function impairment
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| RPC1063Also: Ozanimod | Drug | RPC0163 (Ozanimod) |
Primary outcome
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
Time frame: From first dose to 90 days post last dose (Up to approximately 92 months)
Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.
12 secondary outcomes
Percentage of Participants With Clinical Remission
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Clinical Response
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Endoscopic Improvement
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Corticosteroid-free Remission
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Histologic Remission
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Mucosal Healing
Time frame: Week 46, 94, 142, 190, 238
Change From Baseline in Complete Mayo Score
Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Change From Baseline in Partial Mayo Score
Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Change From Baseline in 9-Point Mayo Score
Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement
Time frame: Week 46, 94, 142, 190, 238
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41003640Yarur A, Irving P, Siegmund B, Dubinsky MC, Ananthakrishnan AN, Regueiro M, Ungaro RC, Ritter T, Nakase H, Liu Z, Mehra D, Osterman MT, Jain A, Rubin DT, Hibi T. Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid. Inflamm Bowel Dis. 2026 Jan 1;32(1):77-86. doi: 10.1093/ibd/izaf195.
- Derived from this study: PubMed 39773524Sands BE, Rubin DT, Loftus EV Jr, Wolf DC, Panaccione R, Colombel JF, Dignass A, Regueiro M, Vermeire S, Afzali A, Lawlor G, Ahmad HA, Wu H, Osterman MT, Jain A, D'Haens G. Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial. Am J Gastroenterol. 2025 Oct 1;120(10):2339-2349. doi: 10.14309/ajg.0000000000003310. Epub 2025 Jan 8.
- 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.
- Derived from this study: PubMed 38723981Sands BE, D'Haens G, Panaccione R, Regueiro M, Ghosh S, Hudesman D, Ahmad HA, Mehra D, Wu H, Jain A, Petersen A, Osterman MT, Afzali A, Danese S. Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2084-2095.e4. doi: 10.1016/j.cgh.2024.03.042. Epub 2024 May 8.
- Derived from this study: PubMed 38040274Armuzzi A, Cross RK, Lichtenstein GR, Hou J, Deepak P, Regueiro M, Wolf DC, Akukwe L, Ahmad HA, Jain A, Kozinn M, Wu H, Petersen A, Charles L, Long M. Cardiovascular Safety of Ozanimod in Patients With Ulcerative Colitis: True North and Open-Label Extension Analyses. Clin Gastroenterol Hepatol. 2024 May;22(5):1067-1076.e3. doi: 10.1016/j.cgh.2023.11.018. Epub 2023 Nov 30.
- Derived from this study: PubMed 33438008Sandborn WJ, Feagan BG, Hanauer S, Vermeire S, Ghosh S, Liu WJ, Petersen A, Charles L, Huang V, Usiskin K, Wolf DC, D'Haens G. Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study. J Crohns Colitis. 2021 Jul 5;15(7):1120-1129. doi: 10.1093/ecco-jcc/jjab012.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
41 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RPC1063 in people with Ulcerative Colitis, run by Celgene at 41 sites in 20 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 1 inclusion and 4 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Bulgaria, Germany, Belgium, Czechia and 15 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 31 Dec 2025). 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?
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) (time frame: From first dose to 90 days post last dose (Up to approximately 92 months)). 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 NCT02531126, which also lists 6 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 31 Dec 2025.