Touchstone: Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

• Sponsor: Celgene (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01647516
• Collaborator: (none)
• Enrollment: 199
• Locations: 88
• Arms: 3
• Actual Duration (Months): 80.1
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Ozanimod; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 199 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis
• Actual Study Start Date: Dec 26, 2012
• Actual Primary Completion Date: Mar 10, 2015
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 [Week 8]

   Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA) Clinical Remission was based on the 4-component Mayo definition.

Secondary Outcome Measures

1. Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8 [Week 8]

   Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Clinical Respone was based on the 4-component Mayo definition.

2. Change From Baseline in Mayo Score at Week 8 [Baseline to Week 8]

   The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)

3. Percentage of Participants With Mucosal Healing at Week 8 [Week 8]

   Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading. The endoscopy scale: 0 = Normal or inactive disease = Mild disease (erythema, decreased vascular pattern, mild friability) = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) = Severe disease (spontaneous bleeding, ulceration)

4. Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32 [Week 32]

   Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)

5. Percentage of Participants Who Achieved Clinical Response at Week 32 [Week 32]

   Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)

6. Percentage of Participants With Mucosal Healing at Week 32 [Week 32]

   Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading. The endoscopy scale: 0 = Normal or inactive disease = Mild disease (erythema, decreased vascular pattern, mild friability) = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) = Severe disease (spontaneous bleeding, ulceration)

7. Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period [From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo]

   A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.

8. Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period [From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.]

   A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.

9. Number of Participants With TEAE During the Open-Label Treatment Period (OLP) [From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years]

   A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 73 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ulcerative colitis (UC) confirmed on endoscopy

• Moderately to severely active UC (Mayo score 6-12)

Exclusion Criteria:

• Current use of anti-TNF agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials	Anaheim	California	United States	92801
2	University of California San Diego	La Jolla	California	United States	92037
3	Alliance Clinical Research	Oceanside	California	United States	92056
4	Atlanta Gastroenterology Associates, LLC	Atlanta	Georgia	United States	30342
5	Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
6	Endoscopic Microsurgery Associates	Towson	Maryland	United States	21204
7	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	United States	48047
8	Long Island Clinical Research Associates	Great Neck	New York	United States	11021
9	University of North Carolina	Chapel Hill	North Carolina	United States	27599
10	Consultants for Clinical Research	Cincinnati	Ohio	United States	45219
11	The Alfred Hospital	Melbourne	Victoria	Australia	3004
12	Universitair Ziekenhuis Leuven, Campus Gasthuisberg	Leuven		Belgium	3000
13	Multiprofile Hospital for Active Treatment Kaspela	Plovdiv		Bulgaria	4000
14	University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia	Sofia		Bulgaria	1407
15	UMHAT Sv Ivan Rilski EAD	Sofia		Bulgaria	1431
16	University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD	Sofia		Bulgaria	1527
17	Military Medical Academy	Sofia		Bulgaria	1606
18	Multiprofile Hospital for Active Treatment Doverie AD	Sofia		Bulgaria	1632
19	Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD	Sofia		Bulgaria	1712
20	Multiprofile Hospital for Active Treatment Sofiamed	Sofia		Bulgaria	1797
21	Multiprofile Hospital for Active Treatment Sveta Marina EAD	Varna		Bulgaria	9010
22	London Health Sciences Centre, University Hospital	London	Ontario	Canada	N6A 5A5
23	Evaggelismos General Hospital	Athens		Greece	106 76
24	University Hospital of Ioannina	Ioannina		Greece	45110
25	University Hospital of Larissa	Larissa		Greece	41110
26	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest		Hungary	1062
27	Pannonia Maganorvosi Centrum	Budapest		Hungary	1136
28	Uzsoki Utcai Korhaz	Budapest		Hungary	1145
29	Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja	Debrecen		Hungary	4025
30	Barzilai Medical Center	Ashkelon		Israel	7830604
31	Carmel Medical Center	Haifa		Israel	34362
32	Wolfson Medical Center	Holon		Israel	5822012
33	Shaare Zedek Medical Center	Jerusalem		Israel	91031
34	Hadassah University Hospital	Jerusalem		Israel	9112001
35	Meir Medical Center	Kfar Saba		Israel	44281
36	Yeungnam University Medical Center	Daegu		Korea, Republic of	705717
37	Konyang University Hospital	Daejon		Korea, Republic of	302718
38	Asan Medical Center	Seoul		Korea, Republic of	05505
39	Kangbuk Samsung Medical Center	Seoul		Korea, Republic of	110746
40	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	120-752
41	Kyunghee University Medical Center	Seoul		Korea, Republic of	130702
42	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of	158-710
43	The Catholic University of Korea, St.Vicent's Hospital	Suwon		Korea, Republic of	442723
44	Wonju Christian Hospital	Wonju		Korea, Republic of	220701
45	Academisch Medisch Centrum	Amsterdam		Netherlands	1105 AZ
46	Albert Schweitzer Ziekenhuis	Dordrecht		Netherlands	3318 AT
47	Ikazia Ziekenhuis	Rotterdam		Netherlands	3083 AN
48	Christchurch Hospital	Christchurch		New Zealand	8011
49	Dunedin Hospital	Dunedin		New Zealand	9016
50	Waikato Hospital	Hamilton		New Zealand	3204
51	Hutt Valley District Health Board	Lower Hutt		New Zealand	5010
52	North Shore Hospital	Milford		New Zealand	0620
53	SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego	Bialystok		Poland
54	Niepubliczny Zaklad Opieki Zdrowotnej INTERMED	Czestochowa		Poland	42-217
55	Elblaski Szpital Specjalistyczny z Przychodnia	Elblag		Poland	82-300
56	Przychodnia Lekarska Nowy Chelm	Gdansk		Poland	80-807
57	Economicus - NZOZ ALL-MEDICUS	Katowice		Poland	40-660
58	Centrum Opieki Zdrowotnej Orkan Med	Ksawerow		Poland	95-054
59	Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny	Lodz		Poland	90-302
60	Instytut Medycyny Wsi	Lublin		Poland	20-090
61	MEDICOR Centrum Medyczne	Rzeszow		Poland	35-068
62	Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED	Warsaw		Poland	03-580
63	Niepubliczny Zaklad Opieki Zdrowotnej Triclinium	Warszawa		Poland	02-797
64	LexMedica Osrodek Badan Klinicznych	Wroclaw		Poland	53-114
65	Regional Clinical Hospital	Krasnoyarsk		Russian Federation	660022
66	SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF	Moscow		Russian Federation	119991
67	Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko	Nizhniy Novgorod		Russian Federation	603126
68	Novosibirsk State Medical University	Novosibirsk		Russian Federation	630084
69	SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF	Omsk		Russian Federation	644043
70	SEIHPE Rostov State Medical University of MoH of RF	Rostov on Don		Russian Federation	344022
71	Russian Medical Military Academy na SMKirov	Saint Petersburg		Russian Federation	191163
72	City Hospital 26	Saint Petersburg		Russian Federation	196247
73	Medical Company Hepatolog	Samara		Russian Federation	443000
74	Slovak Research Center	Ilava		Slovakia	01901
75	Specializovana Nemocnica Svorada Zobor	Nitra		Slovakia	94901
76	GASTRO I., s.r.o.	Presov		Slovakia	080 01
77	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk		Ukraine	76008
78	Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU	Ivano-Frankivsk		Ukraine	76014
79	Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine	Kharkiv		Ukraine	61039
80	Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE	Kyiv		Ukraine	04201
81	Order of the Red Star MMMCC MMCH Clinic of Gastroenterology	Kyiv		Ukraine	1133
82	CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv	Kyiv		Ukraine	2232
83	Lviv Regional Clinical Hospital	Lviv		Ukraine	79010
84	Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU	Lviv		Ukraine	79059
85	Vinnytsia Regional Clinical	Vinnytsia		Ukraine	21018
86	Medical Clinical Research Center "Health Clinic"	Vinnytsya		Ukraine	21029
87	Municipal Institution Zaporizhzhia	Zaporizhzhia		Ukraine	69600
88	Zaporizhzhya city multidisciplinary clinical hospital #9	Zaporizhzhya		Ukraine	69065

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: AnnKatrin Petersen, MD, Bristol-Myers Squibb

Study Documents (Full-Text)

• Study Protocol - May 3, 2019
• Statistical Analysis Plan - Sep 23, 2014

More Information

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.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT01647516
• Other Study ID Numbers: RPC01-202
• First Posted: Jul 23, 2012
• Last Update Posted: May 19, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Ozanimod

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at 57 sites from 13 countries located in Europe, North America, and the Asia-Pacific region.
Pre-assignment Detail	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).

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg	Open-Label Treatment Period (OLP): Placebo/Ozanimod	OLP: Ozanimod 0.5 mg/Ozanimod 1 mg	OLP: Ozanimod 1 mg/Ozanimod 1 mg
Arm/Group Description	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).	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 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 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.	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.	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.
Period Title: Induction Period (IP)
STARTED	66	66	67	0	0	0
Received Study Drug	65	65	67	0	0	0
COMPLETED	60	63	63	0	0	0
NOT COMPLETED	6	3	4	0	0	0
Period Title: Induction Period (IP)
STARTED	25	36	42	0	0	0
COMPLETED	21	30	40	0	0	0
NOT COMPLETED	4	6	2	0	0	0
Period Title: Induction Period (IP)
STARTED	0	0	0	55	56	59
COMPLETED	0	0	0	6	5	3
NOT COMPLETED	0	0	0	49	51	56

Baseline Characteristics

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg	Total
Arm/Group Description	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).	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 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.	Total of all reporting groups
Overall Participants	65	65	67	197
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	41.9 (12.30)	38.8 (12.06)	41.8 (11.01)	40.8 (11.82)
Sex: Female, Male (Count of Participants)
Female	30 46.2%	33 50.8%	19 28.4%	82 41.6%
Male	35 53.8%	32 49.2%	48 71.6%	115 58.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.1%	1 1.5%	0 0%	3 1.5%
Not Hispanic or Latino	63 96.9%	64 98.5%	67 100%	194 98.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	61 93.8%	59 90.8%	62 92.5%	182 92.4%
Black	2 3.1%	1 1.5%	1 1.5%	4 2%
Asian	2 3.1%	3 4.6%	3 4.5%	8 4.1%
Other	0 0%	1 1.5%	1 1.5%	2 1%
Missing	0 0%	1 1.5%	0 0%	1 0.5%
Years Since Ulcerative Colitis Diagnosis (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	6.1 (5.46)	5.9 (5.44)	6.7 (6.76)	6.2 (5.91)
Any Prior Ulcerative Colitis Medication Use (Count of Participants)
Aminosalycylates	63 96.9%	63 96.9%	67 100%	193 98%
Systemic Corticosteroids	52 80%	49 75.4%	52 77.6%	153 77.7%
Azathioprine	17 26.2%	23 35.4%	19 28.4%	59 29.9%
Anti-Tumor Necrosis Factors (Anti-TNF)	10 15.4%	12 18.5%	15 22.4%	37 18.8%
6-Mercaptopurine	2 3.1%	1 1.5%	5 7.5%	8 4.1%
Other Immunomodulators	6 9.2%	5 7.7%	3 4.5%	14 7.1%
Topical Medication	3 4.6%	0 0%	0 0%	3 1.5%
Methotrexate	1 1.5%	1 1.5%	0 0%	2 1%
Mayo Score (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	8.6 (1.51)	8.3 (1.45)	8.5 (1.61)	8.5 (1.52)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	65	65	67
Number [Percentage of Participants]	6.2 9.5%	13.8 21.2%	16.4 24.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 1 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0482
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.262
	Confidence Interval	(2-Sided) 95%; 0.969 to 10.984
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 0.5 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1422
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.500
	Confidence Interval	(2-Sided) 95%; 0.722 to 8.661
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	65	65	67
Number [Percentage of Participants]	36.9 56.8%	53.8 82.8%	56.7 84.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 1 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0207
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.158
	Confidence Interval	(2-Sided) 95%; 1.093 to 4.263
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 0.5 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0648
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.947
	Confidence Interval	(2-Sided) 95%; 0.961 to 3.946
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Mayo Score at Week 8
Description	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)
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	62	64	65
Mean (Standard Deviation) [Units on a Scale]	-2.0 (2.52)	-2.6 (2.92)	-3.4 (2.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 1 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0042
	Comments
	Method	ANCOVA
	Comments	The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 0.5 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1415
	Comments
	Method	ANCOVA
	Comments	The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).

4. Secondary Outcome

Title	Percentage of Participants With Mucosal Healing at Week 8
Description	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)
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	65	65	67
Number [Percentage of Participants]	12.3 18.9%	27.7 42.6%	34.3 51.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 1 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0023
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-TNF therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.861
	Confidence Interval	(2-Sided) 95%; 1.572 to 9.484
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 0.5 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0348
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-TNF therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.647
	Confidence Interval	(2-Sided) 95%; 1.058 to 6.621
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
Description	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)
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	65	65	67
Number [Percentage of Participants]	6.2 9.5%	26.2 40.3%	20.9 31.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 1 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0108
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-TNF therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.332
	Confidence Interval	(2-Sided) 95%; 1.323 to 14.186
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 0.5 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0021
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-TNF therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.443
	Confidence Interval	(2-Sided) 95%; 1.706 to 17.365
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Participants Who Achieved Clinical Response at Week 32
Description	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)
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	65	65	67
Number [Percentage of Participants]	20.0 30.8%	35.4 54.5%	50.7 75.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 1 mg
	Comments
	Type of Statistical Test	Superiority
	Comments	Stratified by prior anti-TNF therapy experience, (yes or no).
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.030
	Confidence Interval	(2-Sided) 95%; 1.871 to 8.678
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 1 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0571
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-TNF therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.154
	Confidence Interval	(2-Sided) 95%; 0.974 to 4.763
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percentage of Participants With Mucosal Healing at Week 32
Description	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)
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	65	65	67
Number [Percentage of Participants]	12.3 18.9%	32.3 49.7%	32.8 49%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 1 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0046
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-TNF therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.557
	Confidence Interval	(2-Sided) 95%; 1.444 to 8.762
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ozanimod Hydrochloride 0.5 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0064
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by prior anti-TNF therapy experience, (yes or no).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.428
	Confidence Interval	(2-Sided) 95%; 1.384 to 8.494
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
Description	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.
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

Outcome Measure Data

Analysis Population Description

Safety population included all participants who were enrolled and received at least 1 dose of investigational product (IP).

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	65	65	67
≥ 1 TEAE	21 32.3%	24 36.9%	17 25.4%
≥ 1 Moderate or Severe TEAE	7 10.8%	12 18.5%	6 9%
≥ 1 Severe TEAE	2 3.1%	1 1.5%	1 1.5%
≥ 1 Possibly, Probably or Definitely Related TEAE	2 3.1%	5 7.7%	5 7.5%
≥ 1 Serious SAE	4 6.2%	1 1.5%	2 3%
≥ 1 Possibly, Probably or Related Serious TEAE	0 0%	0 0%	0 0%
≥ 1 TEAE Leading to Withdrawal From Study	1 1.5%	2 3.1%	1 1.5%
Death	0 0%	0 0%	0 0%

9. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
Description	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.
Time Frame	From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.

Outcome Measure Data

Analysis Population Description

Safety population included all participants who were enrolled and received at least 1 dose of investigational product (IP) and who entered the maintenance period.

Arm/Group Title	Placebo	Ozanimod Hydrochloride 0.5 mg	Ozanimod Hydrochloride 1 mg
Arm/Group Description	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).	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 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.
Measure Participants	25	36	42
≥ 1 TEAE	8 12.3%	4 6.2%	11 16.4%
≥ 1 Moderate or Severe TEAE	4 6.2%	1 1.5%	5 7.5%
≥ 1 Severe TEAE	1 1.5%	0 0%	1 1.5%
≥ 1 Possibly, Probably or Definitely Related TEAE	0 0%	0 0%	2 3%
≥ 1 Serious TEAE	2 3.1%	0 0%	1 1.5%
≥ 1 Possibly, Probably or Related Serious TEAE	0 0%	0 0%	0 0%
≥ 1 TEAE Leading to Withdrawal From Study	3 4.6%	0 0%	0 0%
Death	0 0%	0 0%	0 0%

10. Secondary Outcome

Title	Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
Description	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.
Time Frame	From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ozanimod
Arm/Group Description	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.
Measure Participants	170
≥ 1 TEAE	101 155.4%
≥ 1 Moderate or Severe TEAE	63 96.9%
≥ 1 Severe TEAE	17 26.2%
≥ 1 Possible, Probable or Related TEAE	27 41.5%
≥ 1 Related TEAE	2 3.1%
≥ 1 Serious TEAE	27 41.5%
≥ 1 Related Serious TEAE	0 0%
≥ 1 Possible, Probable or Related Serious TEAE	4 6.2%
≥ 1 TEAE Leading to Discontinuation of IP	14 21.5%
≥ 1 TEAE Leading to Withdrawal from Study	13 20%
Death	1 1.5%
1 Death Possible, Probable or Related to IP	1 1.5%

Adverse Events

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.
Adverse Event Reporting 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.
Arm/Group Title	Induction Period: Placebo		Induction Period: Ozanimod HCL 0.5 mg		Induction Period: Ozanimod HCL 1 mg		Maintenance Period: Placebo		Maintenance Period: Ozanimod HCL 0.5 mg		Maintenance Period: Ozanimod HCL 1 mg		Open-Label Treatment Period (OLP): Placebo/Ozanimod		OLP: Ozanimod 0.5 mg/Ozanimod 1 mg		OLP: Ozanimod 1mg/Ozanimod 1 mg
Arm/Group Description	Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9).		Participants received 0.5 mg ozanimod capsules daily during the induction period (weeks 0 to 9).		Participants received 1 mg ozanimod capsules daily during the induction period (weeks 0 to 9).		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).		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).		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).		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.		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.		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.
All Cause Mortality
	Induction Period: Placebo		Induction Period: Ozanimod HCL 0.5 mg		Induction Period: Ozanimod HCL 1 mg		Maintenance Period: Placebo		Maintenance Period: Ozanimod HCL 0.5 mg		Maintenance Period: Ozanimod HCL 1 mg		Open-Label Treatment Period (OLP): Placebo/Ozanimod		OLP: Ozanimod 0.5 mg/Ozanimod 1 mg		OLP: Ozanimod 1mg/Ozanimod 1 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Serious Adverse Events
	Induction Period: Placebo		Induction Period: Ozanimod HCL 0.5 mg		Induction Period: Ozanimod HCL 1 mg		Maintenance Period: Placebo		Maintenance Period: Ozanimod HCL 0.5 mg		Maintenance Period: Ozanimod HCL 1 mg		Open-Label Treatment Period (OLP): Placebo/Ozanimod		OLP: Ozanimod 0.5 mg/Ozanimod 1 mg		OLP: Ozanimod 1mg/Ozanimod 1 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/65 (6.2%)		1/65 (1.5%)		2/67 (3%)		2/25 (8%)		0/36 (0%)		1/42 (2.4%)		5/55 (9.1%)		14/56 (25%)		11/59 (18.6%)
Blood and lymphatic system disorders
Anaemia	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		1/55 (1.8%)		1/56 (1.8%)		0/59 (0%)
Autoimmune haemolytic anaemia	0/65 (0%)		0/65 (0%)		0/67 (0%)		1/25 (4%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Haemolytic anaemia	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Hypochromic anaemia	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Iron deficiency anaemia	1/65 (1.5%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		0/59 (0%)
Cardiac disorders
Acute coronary syndrome	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		1/55 (1.8%)		0/56 (0%)		0/59 (0%)
Gastrointestinal disorders
Inguinal hernia	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Intestinal obstruction	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Umbilical hernia	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Ascites	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Colitis	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Colitis ulcerative	2/65 (3.1%)		0/65 (0%)		2/67 (3%)		1/25 (4%)		0/36 (0%)		0/42 (0%)		3/55 (5.5%)		1/56 (1.8%)		2/59 (3.4%)
General disorders
Hyperpyrexia	0/65 (0%)		1/65 (1.5%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		0/59 (0%)
Hepatobiliary disorders
Hyperbilirubinaemia	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Jaundice	1/65 (1.5%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Infections and infestations
Erysipelas	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Gastroenteritis viral	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Herpes zoster	0/65 (0%)		0/65 (0%)		0/67 (0%)		1/25 (4%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		0/59 (0%)
Pneumonia	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Pneumonia pneumococcal	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Injury, poisoning and procedural complications
Joint dislocation	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Wrist fracture	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Metabolism and nutrition disorders
Dehydration	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		1/55 (1.8%)		0/56 (0%)		0/59 (0%)
Spinal column stenosis	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Basal cell carcinoma	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Colon adenoma	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		1/42 (2.4%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Prostate cancer	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Nervous system disorders
Ischaemic stroke	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		1/55 (1.8%)		1/56 (1.8%)		0/59 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Psychiatric disorders
Schizophrenia	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Renal and urinary disorders
Nephrolithiasis	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Interstitial lung disease	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Pleurisy	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		1/56 (1.8%)		0/59 (0%)
Pulmonary bulla	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Pulmonary microemboli	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		0/56 (0%)		1/59 (1.7%)
Other (Not Including Serious) Adverse Events
	Induction Period: Placebo		Induction Period: Ozanimod HCL 0.5 mg		Induction Period: Ozanimod HCL 1 mg		Maintenance Period: Placebo		Maintenance Period: Ozanimod HCL 0.5 mg		Maintenance Period: Ozanimod HCL 1 mg		Open-Label Treatment Period (OLP): Placebo/Ozanimod		OLP: Ozanimod 0.5 mg/Ozanimod 1 mg		OLP: Ozanimod 1mg/Ozanimod 1 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/65 (13.8%)		8/65 (12.3%)		8/67 (11.9%)		3/25 (12%)		2/36 (5.6%)		2/42 (4.8%)		19/55 (34.5%)		17/56 (30.4%)		22/59 (37.3%)
Blood and lymphatic system disorders
Anaemia	4/65 (6.2%)		4/65 (6.2%)		1/67 (1.5%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		4/55 (7.3%)		3/56 (5.4%)		0/59 (0%)
Gastrointestinal disorders
Colitis ulcerative	1/65 (1.5%)		2/65 (3.1%)		0/67 (0%)		1/25 (4%)		0/36 (0%)		1/42 (2.4%)		4/55 (7.3%)		0/56 (0%)		0/59 (0%)
Infections and infestations
Bronchitis	0/65 (0%)		0/65 (0%)		1/67 (1.5%)		1/25 (4%)		0/36 (0%)		0/42 (0%)		3/55 (5.5%)		1/56 (1.8%)		0/59 (0%)
Nasopharyngitis	0/65 (0%)		1/65 (1.5%)		0/67 (0%)		0/25 (0%)		1/36 (2.8%)		0/42 (0%)		1/55 (1.8%)		3/56 (5.4%)		3/59 (5.1%)
Respiratory tract infection viral	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		3/55 (5.5%)		1/56 (1.8%)		0/59 (0%)
Upper respiratory tract infection	2/65 (3.1%)		0/65 (0%)		1/67 (1.5%)		1/25 (4%)		0/36 (0%)		0/42 (0%)		3/55 (5.5%)		2/56 (3.6%)		5/59 (8.5%)
Investigations
Alanine aminotransferase increased	0/65 (0%)		0/65 (0%)		2/67 (3%)		0/25 (0%)		1/36 (2.8%)		1/42 (2.4%)		1/55 (1.8%)		2/56 (3.6%)		3/59 (5.1%)
Gamma-glutamyltransferase increased	0/65 (0%)		0/65 (0%)		1/67 (1.5%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		1/55 (1.8%)		3/56 (5.4%)		5/59 (8.5%)
Lymphocyte count decreased	0/65 (0%)		0/65 (0%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		0/55 (0%)		3/56 (5.4%)		3/59 (5.1%)
Musculoskeletal and connective tissue disorders
Back pain	1/65 (1.5%)		1/65 (1.5%)		1/67 (1.5%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		2/55 (3.6%)		1/56 (1.8%)		4/59 (6.8%)
Nervous system disorders
Headache	3/65 (4.6%)		0/65 (0%)		2/67 (3%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		3/55 (5.5%)		1/56 (1.8%)		3/59 (5.1%)
Vascular disorders
Hypertension	0/65 (0%)		1/65 (1.5%)		0/67 (0%)		0/25 (0%)		0/36 (0%)		0/42 (0%)		2/55 (3.6%)		1/56 (1.8%)		7/59 (11.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.