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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01647516
Registration number
NCT01647516
Ethics application status
Date submitted
19/07/2012
Date registered
23/07/2012
Date last updated
19/05/2021
Titles & IDs
Public title
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
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Scientific 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
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Secondary ID [1]
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RPC01-202
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Universal Trial Number (UTN)
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Trial acronym
Touchstone
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Treatment: Drugs - Placebo
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.
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.
Placebo Comparator: Placebo - Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period.
Treatment: Drugs: Ozanimod
Ozanimod capsules by mouth daily.
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
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Assessment method [1]
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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.
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Timepoint [1]
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Week 8
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Secondary outcome [1]
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Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
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Assessment method [1]
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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.
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Timepoint [1]
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Week 8
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Secondary outcome [2]
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Change From Baseline in Mayo Score at Week 8
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Assessment method [2]
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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)
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Timepoint [2]
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Baseline to Week 8
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Secondary outcome [3]
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Percentage of Participants With Mucosal Healing at Week 8
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Assessment method [3]
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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)
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Timepoint [3]
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Week 8
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Secondary outcome [4]
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Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
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Assessment method [4]
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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)
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Timepoint [4]
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Week 32
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Secondary outcome [5]
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Percentage of Participants Who Achieved Clinical Response at Week 32
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Assessment method [5]
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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)
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Timepoint [5]
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Week 32
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Secondary outcome [6]
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Percentage of Participants With Mucosal Healing at Week 32
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Assessment method [6]
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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)
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Timepoint [6]
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Week 32
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Secondary outcome [7]
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Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
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Assessment method [7]
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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.
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Timepoint [7]
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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
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Secondary outcome [8]
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Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
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Assessment method [8]
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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.
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Timepoint [8]
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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.
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Secondary outcome [9]
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Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
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Assessment method [9]
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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.
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Timepoint [9]
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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
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Eligibility
Key inclusion criteria
- Ulcerative colitis (UC) confirmed on endoscopy
- Moderately to severely active UC (Mayo score 6-12)
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Minimum age
18
Years
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Maximum age
73
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current use of anti-TNF agents
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/12/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/08/2019
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Sample size
Target
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Accrual to date
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Final
199
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
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California
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Georgia
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Maryland
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Leuven
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Lower Hutt
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Samara
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Ilava
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Nitra
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Presov
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Ivano-Frankivsk
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Lviv
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Vinnytsia
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Zaporizhzhia
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Ukraine
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Zaporizhzhya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of
ulcerative colitis (UC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01647516
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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AnnKatrin Petersen, MD
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01647516
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