Efficacy and Safety Study of Ozanimod in Ulcerative Colitis | NCT01647516 | Trialant
NCT01647516
Sponsor
Celgene
Status
Completed
Last Update Posted
May 19, 2021Actual
Enrollment
199Actual
Phase
Phase 2
Conditions
Ulcerative Colitis
Interventions
Ozanimod
Placebo
Countries
United States
Australia
Belgium
Bulgaria
Canada
Greece
Hungary
Israel
Netherlands
New Zealand
Poland
Russia
Slovakia
South Korea
Ukraine
Protocol Section
Identification Module
NCT ID
NCT01647516
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RPC01-202
Secondary IDs
Not provided
Brief Title
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
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
Acronym
Touchstone
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
May 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 26, 2012Actual
Primary Completion Date
Mar 10, 2015Actual
Completion Date
Aug 30, 2019Actual
First Submitted Date
Jul 19, 2012
First Submission Date that Met QC Criteria
Jul 19, 2012
First Posted Date
Jul 23, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 30, 2020
Results First Submitted that Met QC Criteria
Sep 21, 2020
Results First Posted Date
Oct 14, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 26, 2016
Certification/Extension First Submitted that Passed QC Review
May 26, 2016
Certification/Extension First Posted Date
Jun 6, 2016Estimated
Last Update Submitted Date
May 14, 2021
Last Update Posted Date
May 19, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
199Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ozanimod 0.5 mg
Experimental
Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
Drug: Ozanimod
Ozanimod 1 mg
Experimental
Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
Drug: Ozanimod
Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ozanimod
Drug
Ozanimod capsules by mouth daily.
Ozanimod 0.5 mg
Ozanimod 1 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Stool Frequency Subscore (SFS)
Rectal bleeding Subscore (RBS)
Endoscopy Subscore
Physician's Global Assessment (PGA)
Clinical Remission was based on the 4-component Mayo definition.
Week 8
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Clinical Respone was based on the 4-component Mayo definition.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Ulcerative colitis (UC) confirmed on endoscopy
Moderately to severely active UC (Mayo score 6-12)
Participants were randomly assigned in a 1:1:1 ratio on Day 1 to placebo, ozanimod 0.5 mg, or ozanimod 1 mg capsules and were stratified by whether they had received anti-tumor necrosis factor class of therapy (yes vs no).
Recruitment Details
Participants were enrolled at 57 sites from 13 countries located in Europe, North America, and the Asia-Pacific region.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period.
Drug: Placebo
Zeposia, RPC 1063
Placebo
Drug
Placebo
Week 8
Change From Baseline in Mayo Score at Week 8
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Stool Frequency Subscore (SFS)
Rectal bleeding Subscore (RBS)
Endoscopy Subscore
Physician's Global Assessment (PGA)
Baseline to Week 8
Percentage of Participants With Mucosal Healing at Week 8
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.
= Severe disease (spontaneous bleeding, ulceration)
Week 8
Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Stool Frequency Subscore (SFS)
Rectal bleeding Subscore (RBS)
Endoscopy Subscore
Physician's Global Assessment (PGA)
Week 32
Percentage of Participants Who Achieved Clinical Response at Week 32
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Stool Frequency Subscore (SFS)
Rectal bleeding Subscore (RBS)
Endoscopy Subscore
Physician's Global Assessment (PGA)
Week 32
Percentage of Participants With Mucosal Healing at Week 32
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.
= Severe disease (spontaneous bleeding, ulceration)
Week 32
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.
Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
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
SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
Omsk
644043
Russia
SEIHPE Rostov State Medical University of MoH of RF
Rostov-on-Don
344022
Russia
Russian Medical Military Academy na SMKirov
Saint Petersburg
191163
Russia
City Hospital 26
Saint Petersburg
196247
Russia
Medical Company Hepatolog
Samara
443000
Russia
Slovak Research Center
Ilava
01901
Slovakia
Specializovana Nemocnica Svorada Zobor
Nitra
94901
Slovakia
GASTRO I., s.r.o.
Prešov
080 01
Slovakia
Yeungnam University Medical Center
Daegu
705717
South Korea
Konyang University Hospital
Daejeon
302718
South Korea
Asan Medical Center
Seoul
05505
South Korea
Kangbuk Samsung Medical Center
Seoul
110746
South Korea
Severance Hospital, Yonsei University Health System
Seoul
120-752
South Korea
Kyunghee University Medical Center
Seoul
130702
South Korea
Ewha Womans University Mokdong Hospital
Seoul
158-710
South Korea
The Catholic University of Korea, St.Vicent's Hospital
Suwon
442723
South Korea
Wonju Christian Hospital
Wŏnju
220701
South Korea
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk
76008
Ukraine
Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk
76014
Ukraine
Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine
Kharkiv
61039
Ukraine
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
Kyiv
04201
Ukraine
Order of the Red Star MMMCC MMCH Clinic of Gastroenterology
Kyiv
1133
Ukraine
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
Kyiv
2232
Ukraine
Lviv Regional Clinical Hospital
Lviv
79010
Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv
79059
Ukraine
Vinnytsia Regional Clinical
Vinnytsia
21018
Ukraine
Medical Clinical Research Center "Health Clinic"
Vinnytsia
21029
Ukraine
Municipal Institution Zaporizhzhia
Zaporizhzhia
69600
Ukraine
Zaporizhzhya city multidisciplinary clinical hospital #9
Zaporizhzhya
69065
Ukraine
Rubin DT, Danese S, Nakase H, Ungaro RC, Wolf DC, Alekseeva O, Petersen A, Liu Z, Mehra D, Jain A, Osterman MT, Krakovich A, Riolo JV, DeBoer E, Appio J, Sinh P, Cree BAC, Cohen JA, Irving P. Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis. Inflamm Bowel Dis. 2026 May 1;32(5):954-962. doi: 10.1093/ibd/izaf319.
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.
Ozanimod Hydrochloride 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.
FG002
Ozanimod Hydrochloride 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.
FG003
Open-Label Treatment Period (OLP): Placebo/Ozanimod
Participants who received placebo capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and receive 1 mg ozanimod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
FG004
OLP: Ozanimod 0.5 mg/Ozanimod 1 mg
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.
FG005
OLP: Ozanimod 1 mg/Ozanimod 1 mg
Participants who received 1 mg ozanimod capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and continue to receive 1 mg ozaninod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
FG00066 subjects
FG00166 subjects
FG00267 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Received Study Drug
FG00065 subjects
FG00165 subjects
FG00267 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00060 subjects
FG00163 subjects
FG00263 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0006 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Physician Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Participant Choice
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
No study drug received
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Period (MP)
Type
Comment
Milestone Data
STARTED
FG00025 subjectsThe MP includes participants who were responders at week 8.
FG00136 subjectsThe MP includes participants who were responders at week 8.
FG00242 subjectsThe MP includes participants who were responders at week 8.
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00021 subjects
FG00130 subjects
FG00240 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG0016 subjects
FG0022 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG003
Open-Label Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00355 subjectsThe participants were:
non-responders at Week 8,completed the MP or had disease relapse during MP
FG00456 subjectsThe participants were:
non-responders at Week 8,completed the MP or had disease relapse during MP
FG00559 subjectsThe participants were:
non-responders at Week 8,completed the MP or had disease relapse during MP
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00349 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The intent to treat ( ITT) population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
BG001
Ozanimod Hydrochloride 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.
BG002
Ozanimod Hydrochloride 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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00065
BG00165
BG00267
BG003197
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00041.9± 12.30
BG00138.8± 12.06
BG00241.8± 11.01
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00030
BG00133
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00061
BG00159
BG002
Years Since Ulcerative Colitis Diagnosis
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG0006.1± 5.46
BG0015.9± 5.44
BG002
Any Prior Ulcerative Colitis Medication Use
Count of Participants
Participants
Title
Denominators
Categories
Aminosalycylates
Title
Measurements
BG00063
BG00163
BG002
Mayo Score
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.
Mean
Standard Deviation
Units on a Scale
Title
Denominators
Categories
Title
Measurements
BG0008.6± 1.51
BG001
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
Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Stool Frequency Subscore (SFS)
Rectal bleeding Subscore (RBS)
Endoscopy Subscore
Physician's Global Assessment (PGA)
Clinical Remission was based on the 4-component Mayo definition.
The intent to treat ( ITT) population consisted of all randomized participants who received at least one dose of study treatment, with treatment. Participants with missing Mayo scores were classified as non-responders.
Posted
Number
Percentage of Participants
Week 8
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
OG001
Ozanimod Hydrochloride 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.
OG002
Ozanimod Hydrochloride 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.
Units
Counts
Participants
OG00065
OG00165
OG00267
Title
Denominators
Categories
Title
Measurements
OG0006.2
OG00113.8
OG00216.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).
0.0482
Odds Ratio (OR)
3.262
2-Sided
95
0.969
10.984
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Clinical Respone was based on the 4-component Mayo definition.
The ITT population consisted of all randomized participants who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Participants with missing Mayo score were considered non-responders. Non responder imputation (NRI).
Posted
Number
Percentage of Participants
Week 8
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
OG001
Ozanimod Hydrochloride 0.5 mg
Secondary
Change From Baseline in Mayo Score at Week 8
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Stool Frequency Subscore (SFS)
Rectal bleeding Subscore (RBS)
Endoscopy Subscore
Physician's Global Assessment (PGA)
The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Includes participants with available data.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline to Week 8
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
OG001
Ozanimod Hydrochloride 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.
Secondary
Percentage of Participants With Mucosal Healing at Week 8
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.
= Severe disease (spontaneous bleeding, ulceration)
The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Non-responder imputation (NRI).
Posted
Number
Percentage of Participants
Week 8
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
OG001
Ozanimod Hydrochloride 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.
Secondary
Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Stool Frequency Subscore (SFS)
Rectal bleeding Subscore (RBS)
Endoscopy Subscore
Physician's Global Assessment (PGA)
The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Participants with missing Mayo score were considered non-responders. Non responder imputation (NRI).
Posted
Number
Percentage of Participants
Week 32
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
OG001
Ozanimod Hydrochloride 0.5 mg
Secondary
Percentage of Participants Who Achieved Clinical Response at Week 32
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
Stool Frequency Subscore (SFS)
Rectal bleeding Subscore (RBS)
Endoscopy Subscore
Physician's Global Assessment (PGA)
The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Participants with missing Mayo score were considered non-responders. Non responder imputation (NRI).
Posted
Number
Percentage of Participants
Week 32
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
OG001
Ozanimod Hydrochloride 0.5 mg
Secondary
Percentage of Participants With Mucosal Healing at Week 32
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.
= Severe disease (spontaneous bleeding, ulceration)
The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Non-responder imputation (NRI).
Posted
Number
Percentage of Participants
Week 32
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
OG001
Ozanimod Hydrochloride 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.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Safety population included all participants who were enrolled and received at least 1 dose of investigational product (IP).
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Safety population included all participants who were enrolled and received at least 1 dose of investigational product (IP) and who entered the maintenance period.
Posted
Count of Participants
Participants
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.
ID
Title
Description
OG000
Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
Secondary
Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Safety population included all participants who were enrolled and received at least 1 dose of investigational product (IP). All participants in the OLE safety population received 1 mg capsules ozanimod as noted in the description.
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Ozanimod
Participants who completed the induction period and were non-responders at Week 8 and those who completed the maintenance period or experienced a disease relapse entered the open label treatment period (OLP) and received 1 mg ozaninod daily up to 6 years. Participants who did not show clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
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 during the induction period.
Description
The mean total duration of study drug exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo during the maintenance period and 2.42 years during the open label treatment period, The safety population includes all participants who received at least dose of study treatment; maintenance phase data includes all participants who entered the maintenance phase.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Induction Period: Placebo
Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9).
0
65
4
65
9
65
EG001
Induction Period: Ozanimod HCL 0.5 mg
Participants received 0.5 mg ozanimod capsules daily during the induction period (weeks 0 to 9).
0
65
1
65
8
65
EG002
Induction Period: Ozanimod HCL 1 mg
Participants received 1 mg ozanimod capsules daily during the induction period (weeks 0 to 9).
0
67
2
67
8
67
EG003
Maintenance Period: Placebo
Participants originally assigned to placebo who completed the induction period and were responders at week 8 continued to receive placebo in the maintenance period. Participants received identically matching placebo capsules daily during the maintenance period (weeks 9-32).
0
25
2
25
3
25
EG004
Maintenance Period: Ozanimod HCL 0.5 mg
Participants originally assigned to ozanimod 0.5 mg who completed the induction period and were responders at week 8 continued to receive ozanimod 0.5 mg daily in the maintenance period. Participants received 0.5 mg ozanimod capsules daily during the maintenance period (weeks 9 to 32).
0
36
0
36
2
36
EG005
Maintenance Period: Ozanimod HCL 1 mg
Participants originally assigned to ozanimod 1 mg who completed the induction period and were responders at week 8 continued to receive ozanimod 0.5 mg daily in the maintenance period. Participants received 1 mg ozanimod capsules daily during the maintenance period (weeks 9 to 32).
0
42
1
42
2
42
EG006
Open-Label Treatment Period (OLP): Placebo/Ozanimod
Participants who received placebo capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and receive 1 mg ozanimod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
0
55
5
55
19
55
EG007
OLP: Ozanimod 0.5 mg/Ozanimod 1 mg
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.
1
56
14
56
17
56
EG008
OLP: Ozanimod 1mg/Ozanimod 1 mg
Participants who received 1 mg ozanimod capsules and completed the induction period and were non-responders at Week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and continue to receive 1 mg ozaninod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
0
59
11
59
22
59
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Inguinal hernia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG0030 affected25 at risk
EG0040 affected36 at risk
EG0050 affected42 at risk
EG0060 affected55 at risk
EG0071 affected56 at risk
EG0080 affected59 at risk
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Hyperpyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0011 affected65 at risk
EG0020 affected67 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Pulmonary bulla
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Pulmonary microemboli
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 affected65 at risk
EG0010 affected65 at risk
EG0022 affected67 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0004 affected65 at risk
EG0014 affected65 at risk
EG0021 affected67 at risk
EG0030 affected25 at risk
EG0040 affected36 at risk
EG0050 affected42 at risk
EG0064 affected55 at risk
EG0073 affected56 at risk
EG0080 affected59 at risk
Colitis ulcerative
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected65 at risk
EG0012 affected65 at risk
EG0020 affected67 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0021 affected67 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0011 affected65 at risk
EG0020 affected67 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0002 affected65 at risk
EG0010 affected65 at risk
EG0021 affected67 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0022 affected67 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0021 affected67 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0010 affected65 at risk
EG0020 affected67 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected65 at risk
EG0011 affected65 at risk
EG0021 affected67 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0003 affected65 at risk
EG0010 affected65 at risk
EG0022 affected67 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected65 at risk
EG0011 affected65 at risk
EG0020 affected67 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).
0.1422
Odds Ratio (OR)
2.500
2-Sided
95
0.722
8.661
Superiority
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.
OG002
Ozanimod Hydrochloride 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.
Units
Counts
Participants
OG00065
OG00165
OG00267
Title
Denominators
Categories
Title
Measurements
OG00036.9
OG00153.8
OG00256.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).
0.0207
Odds Ratio (OR)
2.158
2-Sided
95
1.093
4.263
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).
0.0648
Odds Ratio (OR)
1.947
2-Sided
95
0.961
3.946
Superiority
OG002
Ozanimod Hydrochloride 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.
Units
Counts
Participants
OG00062
OG00164
OG00265
Title
Denominators
Categories
Title
Measurements
OG000-2.0± 2.52
OG001-2.6± 2.92
OG002-3.4± 2.79
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).
0.0042
Superiority
OG000
OG001
ANCOVA
The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).
0.1415
Superiority
OG002
Ozanimod Hydrochloride 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.
Units
Counts
Participants
OG00065
OG00165
OG00267
Title
Denominators
Categories
Title
Measurements
OG00012.3
OG00127.7
OG00234.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by prior anti-TNF therapy experience, (yes or no).
0.0023
Odds Ratio (OR)
3.861
2-Sided
95
1.572
9.484
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by prior anti-TNF therapy experience, (yes or no).
0.0348
Odds Ratio (OR)
2.647
2-Sided
95
1.058
6.621
Superiority
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.
OG002
Ozanimod Hydrochloride 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.
Units
Counts
Participants
OG00065
OG00165
OG00267
Title
Denominators
Categories
Title
Measurements
OG0006.2
OG00126.2
OG00220.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by prior anti-TNF therapy experience, (yes or no).
0.0108
Odds Ratio (OR)
4.332
2-Sided
95
1.323
14.186
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by prior anti-TNF therapy experience, (yes or no).
0.0021
Odds Ratio (OR)
5.443
2-Sided
95
1.706
17.365
Superiority
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.
OG002
Ozanimod Hydrochloride 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.
Units
Counts
Participants
OG00065
OG00165
OG00267
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00135.4
OG00250.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
0.0002
Odds Ratio (OR)
4.030
2-Sided
95
1.871
8.678
Superiority
Stratified by prior anti-TNF therapy experience, (yes or no).
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by prior anti-TNF therapy experience, (yes or no).
0.0571
Odds Ratio (OR)
2.154
2-Sided
95
0.974
4.763
Superiority
OG002
Ozanimod Hydrochloride 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.
Units
Counts
Participants
OG00065
OG00165
OG00267
Title
Denominators
Categories
Title
Measurements
OG00012.3
OG00132.3
OG00232.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by prior anti-TNF therapy experience, (yes or no).
0.0046
Odds Ratio (OR)
3.557
2-Sided
95
1.444
8.762
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by prior anti-TNF therapy experience, (yes or no).
0.0064
Odds Ratio (OR)
3.428
2-Sided
95
1.384
8.494
Superiority
OG001
Ozanimod Hydrochloride 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.
OG002
Ozanimod Hydrochloride 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.
Units
Counts
Participants
OG00065
OG00165
OG00267
Title
Denominators
Categories
≥ 1 TEAE
Title
Measurements
OG00021
OG00124
OG00217
≥ 1 Moderate or Severe TEAE
Title
Measurements
OG0007
OG00112
OG0026
≥ 1 Severe TEAE
Title
Measurements
OG0002
OG0011
OG0021
≥ 1 Possibly, Probably or Definitely Related TEAE
Title
Measurements
OG0002
OG0015
OG0025
≥ 1 Serious SAE
Title
Measurements
OG0004
OG0011
OG0022
≥ 1 Possibly, Probably or Related Serious TEAE
Title
Measurements
OG0000
OG0010
OG0020
≥ 1 TEAE Leading to Withdrawal From Study
Title
Measurements
OG0001
OG0012
OG0021
Death
Title
Measurements
OG0000
OG0010
OG0020
OG001
Ozanimod Hydrochloride 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.
OG002
Ozanimod Hydrochloride 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.