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Efficacy and Safety Study of Ozanimod in Ulcerative Colitis (Touchstone)

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ClinicalTrials.gov Identifier: NCT01647516
Recruitment Status : Completed
First Posted : July 23, 2012
Results First Posted : October 14, 2020
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Ozanimod Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 26, 2012
Actual Primary Completion Date : March 10, 2015
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ozanimod 0.5 mg
Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
Drug: Ozanimod
Ozanimod capsules by mouth daily.
Other Name: Zeposia, RPC 1063

Experimental: Ozanimod 1 mg
Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
Drug: Ozanimod
Ozanimod capsules by mouth daily.
Other Name: Zeposia, RPC 1063

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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8 [ Time Frame: 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.


  2. Change From Baseline in Mayo Score at Week 8 [ Time Frame: Baseline to 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)

  3. Percentage of Participants With Mucosal Healing at Week 8 [ Time Frame: 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

    1. = Mild disease (erythema, decreased vascular pattern, mild friability)
    2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)
    3. = Severe disease (spontaneous bleeding, ulceration)

  4. Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32 [ Time Frame: 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)

  5. Percentage of Participants Who Achieved Clinical Response at Week 32 [ Time Frame: 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)

  6. Percentage of Participants With Mucosal Healing at Week 32 [ Time Frame: 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

    1. = Mild disease (erythema, decreased vascular pattern, mild friability)
    2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)
    3. = Severe disease (spontaneous bleeding, ulceration)

  7. 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 ]
    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.

  8. 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. ]
    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.

  9. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Current use of anti-TNF agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647516


Locations
Show Show 88 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: AnnKatrin Petersen, MD Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Celgene:
Study Protocol  [PDF] May 3, 2019
Statistical Analysis Plan  [PDF] September 23, 2014

Publications:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01647516    
Other Study ID Numbers: RPC01-202
First Posted: July 23, 2012    Key Record Dates
Results First Posted: October 14, 2020
Last Update Posted: May 19, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases