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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001600-64 | EudraCT Number | ||
| U1111-1218-0284 | Registry Identifier | WHO |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPC0163 (Ozanimod) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPC1063 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose to 90 days post last dose (Up to approximately 92 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 144 | Tucson | Arizona | 85712 | United States | ||
| Local Institution - 102 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41003640 | Derived | 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. | |
| 39773524 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | RPC01-3101 Placebo-Placebo | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily |
| FG001 | RPC01-3101 Ozanimod-Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2022 |
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| 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. | 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;
| 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). | 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. | 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.) | 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:
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. | 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:
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. | 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:
| 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). | 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. | 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) | Week 46, 94, 142, 190, 238 |
| Anaheim |
| California |
| 92801 |
| United States |
| Local Institution - 117 | Mission Hills | California | 91345 | United States |
| Local Institution - 112 | Oak Lawn | Illinois | 60453 | United States |
| Local Institution - 119 | Baton Rouge | Louisiana | 70809 | United States |
| Local Institution - 127 | Jacksonville | North Carolina | 28546 | United States |
| Local Institution - 290 | Oklahoma City | Oklahoma | 73112 | United States |
| Local Institution - 143 | Portland | Oregon | 97239 | United States |
| Local Institution - 179 | Germantown | Tennessee | 38138 | United States |
| Local Institution - 122 | Dallas | Texas | 75246 | United States |
| Local Institution - 152 | Camperdown | New South Wales | 2050 | Australia |
| Local Institution - 751 | Vitebsk | 210037 | Belarus |
| Local Institution - 600 | Ghent | 9000 | Belgium |
| Local Institution - 601 | Leuven | 3000 | Belgium |
| Local Institution - 450 | Sofia | 1233 | Bulgaria |
| Local Institution - 459 | Sofia | 1336 | Bulgaria |
| Local Institution - 451 | Sofia | 1606 | Bulgaria |
| Local Institution - 264 | Lindsay | Ontario | K9V 5G6 | Canada |
| Local Institution - 611 | Osijek | 31000 | Croatia |
| Local Institution - 342 | Klatovy | 399 01 | Czechia |
| Local Institution - 337 | Prague | 14021 | Czechia |
| Local Institution - 535 | Berlin | 12200 | Germany |
| Local Institution - 525 | Berlin | 13353 | Germany |
| Local Institution - 545 | Frankfurt | 60594 | Germany |
| Local Institution - 643 | Athens | 10676 | Greece |
| Local Institution - 816 | Balatonfüred | 8230 | Hungary |
| Local Institution - 808 | Debrecen | 4032 | Hungary |
| Local Institution - 505 | Rehovot | 76100 | Israel |
| Local Institution - 567 | Florence | Tuscany | 50134 | Italy |
| Local Institution - 658 | Chisinau | MD-2068 | Moldova |
| Local Institution - 659 | Chisinau | MD2025 | Moldova |
| Local Institution - 425 | Kłodzko | 57-300 | Poland |
| Local Institution - 677 | Bucharest | 010719 | Romania |
| Local Institution - 673 | Bucharest | 050098 | Romania |
| Local Institution - 910 | Bardejov | 08501 | Slovakia |
| Local Institution - 364 | Seongnam-si | 13620 | South Korea |
| Local Institution - 354 | Wŏnju | 26426 | South Korea |
| Local Institution - 954 | Kharkiv | 61039 | Ukraine |
| Local Institution - 957 | Vinnytsia | 21018 | Ukraine |
| Local Institution - 236 | London | GREATER LONDON | E11 1NR | United Kingdom |
| Local Institution - 243 | London | SE1 9RT | United Kingdom |
| Sands 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. |
| 39018016 | Derived | 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. |
| 38723981 | Derived | Sands 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. |
| 38040274 | Derived | Armuzzi 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. |
| 33438008 | Derived | Sandborn 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 Patient Recruiting | View source |
Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily
| FG002 | RPC01-3101 Ozanimod-Ozanimod | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily |
| FG003 | RPC01-202 Ozanimod Open Label | Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RPC01-3101 Placebo-Placebo | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily |
| BG001 | RPC01-3101 Ozanimod-Placebo | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily |
| BG002 | RPC01-3101 Ozanimod-Ozanimod | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily |
| BG003 | RPC01-202 Ozanimod Open Label | Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose to 90 days post last dose (Up to approximately 92 months) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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). | All treated participants who are evaluated for clinical remission at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All treated participants who are evaluated for clinical response at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Improvement | Endoscopic Improvement is defined as endoscopy subscore of <=1 point. 0 = Normal or inactive disease;
| All treated participants who are evaluated for endoscopic improvement at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | All treated participants who are evaluated for corticosteroid-free remission at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All treated participants who are evaluated for histologic remission at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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.) | All treated participants who are evaluated for mucosal healing at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Complete Mayo Score | The Complete Mayo Score is a composite of four assessments, each rated from 0 to 3:
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. | All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points | Posted | Mean | Standard Deviation | Score on a scale | Baseline, week 46, 94, 142, 190, 238, 286, 334, 382 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Partial Mayo Score | The Partial Mayo Score is a composite of three assessments, each rated from 0 to 3:
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. | All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points | Posted | Mean | Standard Deviation | Score on a scale | Baseline, week 46, 94, 142, 190, 238, 286, 334, 382 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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:
| All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points | Posted | Mean | Standard Deviation | Score on a scale | Baseline, week 46, 94, 142, 190, 238, 286, 334, 382 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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). | All treated participants who had previously received anti-TNF therapy and who are evaluated for clinical remission at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All treated participants who had Previously Received anti-TNF Therapy and who are evaluated for clinical response at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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) | All treated participants who had Previously Received anti-TNF Therapy and who are evaluated for endoscopic improvement at the specified visit point | Posted | Number | Percentage of participants | Week 46, 94, 142, 190, 238 |
|
Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RPC01-3101 Placebo-Placebo | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily | 0 | 184 | 24 | 184 | 98 | 184 |
| EG001 | RPC01-3101 Ozanimod-Placebo | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily | 0 | 196 | 41 | 196 | 121 | 196 |
| EG002 | RPC01-3101 Ozanimod-Ozanimod | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily | 3 | 443 | 76 | 443 | 245 | 443 |
| EG003 | RPC01-202 Ozanimod Open Label | Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily | 0 | 54 | 8 | 54 | 24 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arnold-Chiari malformation | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Congenital anomaly in offspring | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colon dysplasia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders and administration site conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Sudden death | General disorders and administration site conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Keratouveitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| West Nile viral infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Colorectal cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Follicular lymphoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hemihypoaesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestine anastomosis | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Dec 10, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000607776 | ozanimod |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Serious TEAEs |
|
| TEAE Leading to Discontinuation of Study Drug |
|
| TEAEs of Special Interest |
|
| OG003 | RPC01-202 Ozanimod Open Label | Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
| OG003 | RPC01-202 Ozanimod Open Label | Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
| RPC01-202 Ozanimod Open Label |
Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
| OG003 | RPC01-202 Ozanimod Open Label | Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
|
|
| RPC01-202 Ozanimod Open Label |
Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
| OG002 | RPC01-3101 Ozanimod-Ozanimod | Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
| RPC01-3101 Ozanimod-Ozanimod |
Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
| RPC01-3101 Ozanimod-Ozanimod |
Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
| OG003 | RPC01-202 Ozanimod Open Label | Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily
| OG003 | RPC01-202 Ozanimod Open Label | Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
|
|
Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily |
|
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