Trial Outcomes & Findings for An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (NCT NCT02531126)

Last Updated: 2025-12-31

Results Overview

Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

877 participants

Primary outcome timeframe

From first dose to 90 days post last dose (Up to approximately 92 months)

Results posted on

2025-12-31

Participant Flow

Participant milestones

Participant milestones
Measure	RPC01-3101 Placebo-Placebo Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Overall Study STARTED	184	196	443	54
Overall Study COMPLETED	41	78	135	29
Overall Study NOT COMPLETED	143	118	308	25

Reasons for withdrawal

Reasons for withdrawal
Measure	RPC01-3101 Placebo-Placebo Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Overall Study Non-compliance with protocol/protocol deviation	5	0	3	0
Overall Study Adverse Event	16	13	27	4
Overall Study Lack of Efficacy	50	32	121	0
Overall Study Withdrawal by Subject	38	31	96	6
Overall Study Pregnancy	2	3	2	0
Overall Study Switched to commercial drug	2	4	4	0
Overall Study Other reasons	23	29	27	15
Overall Study Physician Decision	6	6	28	0
Overall Study Non-compliance with investigational drug	1	0	0	0

Baseline Characteristics

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RPC01-3101 Placebo-Placebo n=184 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=196 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=443 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label n=54 Participants Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily	Total n=877 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1000 Participants	0 Participants n=1986 Participants	0 Participants n=2008 Participants	0 Participants n=4994 Participants	0 Participants n=62 Participants
Age, Categorical Between 18 and 65 years	171 Participants n=1000 Participants	188 Participants n=1986 Participants	420 Participants n=2008 Participants	54 Participants n=4994 Participants	833 Participants n=62 Participants
Age, Categorical >=65 years	13 Participants n=1000 Participants	8 Participants n=1986 Participants	23 Participants n=2008 Participants	0 Participants n=4994 Participants	44 Participants n=62 Participants
Sex: Female, Male Female	60 Participants n=1000 Participants	91 Participants n=1986 Participants	184 Participants n=2008 Participants	22 Participants n=4994 Participants	357 Participants n=62 Participants
Sex: Female, Male Male	124 Participants n=1000 Participants	105 Participants n=1986 Participants	259 Participants n=2008 Participants	32 Participants n=4994 Participants	520 Participants n=62 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=1000 Participants	11 Participants n=1986 Participants	19 Participants n=2008 Participants	1 Participants n=4994 Participants	37 Participants n=62 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	178 Participants n=1000 Participants	185 Participants n=1986 Participants	424 Participants n=2008 Participants	53 Participants n=4994 Participants	840 Participants n=62 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1000 Participants	0 Participants n=1986 Participants	0 Participants n=2008 Participants	0 Participants n=4994 Participants	0 Participants n=62 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1000 Participants	0 Participants n=1986 Participants	0 Participants n=2008 Participants	0 Participants n=4994 Participants	0 Participants n=62 Participants
Race (NIH/OMB) Asian	13 Participants n=1000 Participants	10 Participants n=1986 Participants	31 Participants n=2008 Participants	3 Participants n=4994 Participants	57 Participants n=62 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1000 Participants	0 Participants n=1986 Participants	0 Participants n=2008 Participants	0 Participants n=4994 Participants	0 Participants n=62 Participants
Race (NIH/OMB) Black or African American	4 Participants n=1000 Participants	9 Participants n=1986 Participants	11 Participants n=2008 Participants	1 Participants n=4994 Participants	25 Participants n=62 Participants
Race (NIH/OMB) White	165 Participants n=1000 Participants	174 Participants n=1986 Participants	394 Participants n=2008 Participants	48 Participants n=4994 Participants	781 Participants n=62 Participants
Race (NIH/OMB) More than one race	0 Participants n=1000 Participants	0 Participants n=1986 Participants	0 Participants n=2008 Participants	0 Participants n=4994 Participants	0 Participants n=62 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=1000 Participants	3 Participants n=1986 Participants	7 Participants n=2008 Participants	2 Participants n=4994 Participants	14 Participants n=62 Participants

PRIMARY outcome

Timeframe: From first dose to 90 days post last dose (Up to approximately 92 months)

Population: All treated participants

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=184 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=196 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=443 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label n=54 Participants Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) TEAEs	139 Participants	160 Participants	342 Participants	37 Participants
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) Serious TEAEs	24 Participants	41 Participants	76 Participants	8 Participants
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) TEAE Leading to Discontinuation of Study Drug	17 Participants	14 Participants	33 Participants	4 Participants
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) TEAEs of Special Interest	28 Participants	32 Participants	55 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for clinical remission at the specified visit point

Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore \<=1 (and a decrease of \>=1 point from the baseline stool frequency subscore); and endoscopy subscore \<=1. Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=113 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=140 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=266 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants With Clinical Remission week 46	41.6 Percentage of participants	62.9 Percentage of participants	44.0 Percentage of participants	—
Percentage of Participants With Clinical Remission week 94	57.8 Percentage of participants	59.0 Percentage of participants	50.5 Percentage of participants	—
Percentage of Participants With Clinical Remission week 142	59.4 Percentage of participants	60.4 Percentage of participants	50.9 Percentage of participants	—
Percentage of Participants With Clinical Remission week 190	39.1 Percentage of participants	64.9 Percentage of participants	54.7 Percentage of participants	—
Percentage of Participants With Clinical Remission week 238	38.5 Percentage of participants	63.8 Percentage of participants	54.5 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for clinical response at the specified visit point

Clinical response is defined as reduction from baseline in the 9-point Mayo score of \>=2 points and reduction from baseline in the 9-point Mayo score \>=35%, and (reduction from baseline in the rectal bleeding subscore of \>=1 point or a rectal bleeding subscore of \<=1 point). 9 point Mayo score is defined as the sum of rectal bleeding subscore, stool frequency subscore, and the endoscopy subscore each ranging from (0=normal activity-3=worse activity) for a total score that ranges from 0 to 9 with higher score indicating worsening symptoms.

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=110 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=136 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=261 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants With Clinical Response week 46	81.8 Percentage of participants	89.7 Percentage of participants	77.0 Percentage of participants	—
Percentage of Participants With Clinical Response week 94	84.1 Percentage of participants	92.9 Percentage of participants	83.9 Percentage of participants	—
Percentage of Participants With Clinical Response week 142	89.6 Percentage of participants	90.2 Percentage of participants	87.6 Percentage of participants	—
Percentage of Participants With Clinical Response week 190	82.2 Percentage of participants	96.1 Percentage of participants	86.4 Percentage of participants	—
Percentage of Participants With Clinical Response week 238	74.4 Percentage of participants	91.2 Percentage of participants	90.1 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for endoscopic improvement at the specified visit point

Endoscopic Improvement is defined as endoscopy subscore of \<=1 point. 0 = Normal or inactive disease; 1. = Mild disease (erythema, decreased vascular pattern, does not include friability) 2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3. = Severe disease (spontaneous bleeding, ulceration)

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=121 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=150 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=290 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label n=30 Participants Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants With Endoscopic Improvement week 94	60.6 Percentage of participants	66.9 Percentage of participants	58.6 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With Endoscopic Improvement week 142	61.1 Percentage of participants	66.1 Percentage of participants	60.8 Percentage of participants	57.7 Percentage of participants
Percentage of Participants With Endoscopic Improvement week 190	49.1 Percentage of participants	71.3 Percentage of participants	62.5 Percentage of participants	56.3 Percentage of participants
Percentage of Participants With Endoscopic Improvement week 238	43.5 Percentage of participants	69.3 Percentage of participants	60.9 Percentage of participants	100 Percentage of participants
Percentage of Participants With Endoscopic Improvement week 46	51.2 Percentage of participants	72.0 Percentage of participants	49.7 Percentage of participants	41.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for corticosteroid-free remission at the specified visit point

Corticosteroid-free remission is defined as clinical remission while off corticosteroids for ≥12 weeks. Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore \<=1 (and a decrease of \>=1 point from the baseline stool frequency subscore); and endoscopy subscore \<=1. Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=113 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=140 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=266 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants With Corticosteroid-free Remission week 46	40.7 Percentage of participants	53.6 Percentage of participants	38.0 Percentage of participants	—
Percentage of Participants With Corticosteroid-free Remission week 94	52.2 Percentage of participants	49.6 Percentage of participants	41.6 Percentage of participants	—
Percentage of Participants With Corticosteroid-free Remission week 142	55.1 Percentage of participants	55.7 Percentage of participants	45.1 Percentage of participants	—
Percentage of Participants With Corticosteroid-free Remission week 190	37.0 Percentage of participants	57.1 Percentage of participants	47.3 Percentage of participants	—
Percentage of Participants With Corticosteroid-free Remission week 238	38.5 Percentage of participants	60.3 Percentage of participants	48.2 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for histologic remission at the specified visit point

Histologic remission is defined as Geboes index score \< 2.0. The Geboes score is a validated histological grading system for UC that ranges from 0=no disease activity to 5=high disease activity.

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=108 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=141 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=276 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label n=30 Participants Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants With Histologic Remission week 190	42.9 Percentage of participants	53.0 Percentage of participants	47.5 Percentage of participants	62.5 Percentage of participants
Percentage of Participants With Histologic Remission week 238	34.1 Percentage of participants	57.1 Percentage of participants	56.1 Percentage of participants	100 Percentage of participants
Percentage of Participants With Histologic Remission week 142	32.9 Percentage of participants	37.7 Percentage of participants	32.4 Percentage of participants	48.0 Percentage of participants
Percentage of Participants With Histologic Remission week 46	19.4 Percentage of participants	30.5 Percentage of participants	25.4 Percentage of participants	48.1 Percentage of participants
Percentage of Participants With Histologic Remission week 94	22.6 Percentage of participants	36.4 Percentage of participants	32.8 Percentage of participants	26.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for mucosal healing at the specified visit point

Mucosal Healing is defined as Endoscopy subscore of ≤ 1 point (0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability)) and a Geboes index score \< 2.0 (The Geboes score is a validated histological grading system for UC that ranges from 0=no disease activity to 5=high disease activity.)

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=108 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=141 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=276 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label n=30 Participants Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants With Mucosal Healing week 46	14.8 Percentage of participants	27.0 Percentage of participants	20.4 Percentage of participants	25.9 Percentage of participants
Percentage of Participants With Mucosal Healing week 94	19.0 Percentage of participants	34.5 Percentage of participants	28.0 Percentage of participants	20.0 Percentage of participants
Percentage of Participants With Mucosal Healing week 142	32.8 Percentage of participants	32.1 Percentage of participants	27.4 Percentage of participants	44.0 Percentage of participants
Percentage of Participants With Mucosal Healing week 190	32.7 Percentage of participants	48.8 Percentage of participants	43.9 Percentage of participants	37.5 Percentage of participants
Percentage of Participants With Mucosal Healing week 238	26.8 Percentage of participants	48.6 Percentage of participants	46.3 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382

Population: All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points

The Complete Mayo Score is a composite of four assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. endoscopy (0 = Normal or inactive disease; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease) 4. Physician's Global Assessment (0 = Normal; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease). The total score range is from 0-12, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=108 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=132 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=255 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Change From Baseline in Complete Mayo Score week 46	-3.5 Score on a scale Standard Deviation 3.06	-2.9 Score on a scale Standard Deviation 3.31	-1.8 Score on a scale Standard Deviation 2.88	—
Change From Baseline in Complete Mayo Score week 94	-3.7 Score on a scale Standard Deviation 3.30	-2.7 Score on a scale Standard Deviation 3.21	-2.2 Score on a scale Standard Deviation 3.16	—
Change From Baseline in Complete Mayo Score week 142	-4.2 Score on a scale Standard Deviation 3.42	-2.7 Score on a scale Standard Deviation 3.38	-2.5 Score on a scale Standard Deviation 3.17	—
Change From Baseline in Complete Mayo Score week 190	-3.6 Score on a scale Standard Deviation 3.37	-2.3 Score on a scale Standard Deviation 3.35	-2.6 Score on a scale Standard Deviation 3.24	—
Change From Baseline in Complete Mayo Score week 238	-3.4 Score on a scale Standard Deviation 3.30	-2.6 Score on a scale Standard Deviation 3.50	-2.9 Score on a scale Standard Deviation 3.39	—
Change From Baseline in Complete Mayo Score week 286	-4.1 Score on a scale Standard Deviation 2.99	-5.2 Score on a scale Standard Deviation 3.54	-3.9 Score on a scale Standard Deviation 3.44	—
Change From Baseline in Complete Mayo Score week 334	-4.5 Score on a scale Standard Deviation 6.36	—	-4.4 Score on a scale Standard Deviation 3.46	—
Change From Baseline in Complete Mayo Score week 382	—	—	-4.0 Score on a scale Standard Deviation NA insufficient number of participants to calculate standard deviation	—

SECONDARY outcome

Timeframe: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382

Population: All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points

The Partial Mayo Score is a composite of three assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. Physician's Global Assessment (0 = Normal; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease). The total score range is from 0-9, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=114 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=153 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=281 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Change From Baseline in Partial Mayo Score week 142	-3.1 Score on a scale Standard Deviation 2.75	-2.3 Score on a scale Standard Deviation 2.66	-1.9 Score on a scale Standard Deviation 2.31	—
Change From Baseline in Partial Mayo Score week 46	-2.8 Score on a scale Standard Deviation 2.50	-2.2 Score on a scale Standard Deviation 2.56	-1.4 Score on a scale Standard Deviation 2.20	—
Change From Baseline in Partial Mayo Score week 94	-2.9 Score on a scale Standard Deviation 2.65	-2.1 Score on a scale Standard Deviation 2.64	-1.8 Score on a scale Standard Deviation 2.35	—
Change From Baseline in Partial Mayo Score week 190	-3.0 Score on a scale Standard Deviation 2.42	-2.0 Score on a scale Standard Deviation 2.71	-2.0 Score on a scale Standard Deviation 2.39	—
Change From Baseline in Partial Mayo Score week 238	-2.8 Score on a scale Standard Deviation 2.62	-2.1 Score on a scale Standard Deviation 2.60	-2.2 Score on a scale Standard Deviation 2.61	—
Change From Baseline in Partial Mayo Score week 286	-3.5 Score on a scale Standard Deviation 2.29	-3.9 Score on a scale Standard Deviation 3.34	-3.5 Score on a scale Standard Deviation 2.70	—
Change From Baseline in Partial Mayo Score week 334	-2.5 Score on a scale Standard Deviation 6.36	—	-2.8 Score on a scale Standard Deviation 2.60	—
Change From Baseline in Partial Mayo Score week 382	-6.0 Score on a scale Standard Deviation NA insufficient number of participants to calculate standard deviation	—	-4.0 Score on a scale Standard Deviation NA insufficient number of participants to calculate standard deviation	—

SECONDARY outcome

Timeframe: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382

Population: All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points

The 9-point Mayo Score is a composite of three assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. Endoscopy (0 = Normal or inactive disease; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease) The total score range is from 0-9, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=108 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=132 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=255 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Change From Baseline in 9-Point Mayo Score week 46	-2.4 Score on a scale Standard Deviation 2.31	-2.1 Score on a scale Standard Deviation 2.48	-1.3 Score on a scale Standard Deviation 2.23	—
Change From Baseline in 9-Point Mayo Score week 94	-2.5 Score on a scale Standard Deviation 2.48	-1.8 Score on a scale Standard Deviation 2.47	-1.5 Score on a scale Standard Deviation 2.44	—
Change From Baseline in 9-Point Mayo Score week 142	-2.8 Score on a scale Standard Deviation 2.66	-1.8 Score on a scale Standard Deviation 2.62	-1.6 Score on a scale Standard Deviation 2.45	—
Change From Baseline in 9-Point Mayo Score week 190	-2.4 Score on a scale Standard Deviation 2.61	-1.5 Score on a scale Standard Deviation 2.53	-1.7 Score on a scale Standard Deviation 2.48	—
Change From Baseline in 9-Point Mayo Score week 238	-2.2 Score on a scale Standard Deviation 2.52	-1.6 Score on a scale Standard Deviation 2.62	-2.0 Score on a scale Standard Deviation 2.54	—
Change From Baseline in 9-Point Mayo Score week 286	-3.0 Score on a scale Standard Deviation 2.33	-3.5 Score on a scale Standard Deviation 2.43	-2.8 Score on a scale Standard Deviation 2.59	—
Change From Baseline in 9-Point Mayo Score week 334	-3.5 Score on a scale Standard Deviation 4.95	—	-3.1 Score on a scale Standard Deviation 2.47	—
Change From Baseline in 9-Point Mayo Score week 382	—	—	-3.0 Score on a scale Standard Deviation NA insufficient number of participants to calculate standard deviation	—

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who had previously received anti-TNF therapy and who are evaluated for clinical remission at the specified visit point

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=26 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=36 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=266 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission week 142	44.4 Percentage of participants	66.7 Percentage of participants	42.3 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission week 190	42.9 Percentage of participants	75.0 Percentage of participants	48.8 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission week 46	19.2 Percentage of participants	44.4 Percentage of participants	31.4 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission week 94	46.7 Percentage of participants	52.0 Percentage of participants	43.8 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission week 238	28.6 Percentage of participants	58.8 Percentage of participants	47.4 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who had Previously Received anti-TNF Therapy and who are evaluated for clinical response at the specified visit point

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=110 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=136 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=261 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response week 46	64.0 Percentage of participants	71.4 Percentage of participants	74.1 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response week 94	64.3 Percentage of participants	95.8 Percentage of participants	84.1 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response week 142	75.0 Percentage of participants	90.0 Percentage of participants	84.3 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response week 190	85.7 Percentage of participants	95.0 Percentage of participants	88.1 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response week 238	71.4 Percentage of participants	76.5 Percentage of participants	86.5 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 46, 94, 142, 190, 238

Population: All treated participants who had Previously Received anti-TNF Therapy and who are evaluated for endoscopic improvement at the specified visit point

Endoscopic Improvement is defined as endoscopy subscore of \<=1 point. 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability)

Outcome measures

Outcome measures
Measure	RPC01-3101 Placebo-Placebo n=121 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=150 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=290 Participants Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label n=30 Participants Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement week 238	42.9 Percentage of participants	61.9 Percentage of participants	60.5 Percentage of participants	—
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement week 94	50.0 Percentage of participants	66.7 Percentage of participants	56.1 Percentage of participants	33.3 Percentage of participants
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement week 142	40.0 Percentage of participants	76.2 Percentage of participants	56.9 Percentage of participants	75.0 Percentage of participants
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement week 190	60.0 Percentage of participants	81.8 Percentage of participants	57.1 Percentage of participants	100 Percentage of participants
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement week 46	28.6 Percentage of participants	55.3 Percentage of participants	37.5 Percentage of participants	50.0 Percentage of participants

Adverse Events

RPC01-3101 Placebo-Placebo

Serious events: 24 serious events

Other events: 98 other events

Deaths: 0 deaths

RPC01-3101 Ozanimod-Placebo

Serious events: 41 serious events

Other events: 121 other events

Deaths: 0 deaths

RPC01-3101 Ozanimod-Ozanimod

Serious events: 76 serious events

Other events: 245 other events

Deaths: 3 deaths

RPC01-202 Ozanimod Open Label

Serious events: 8 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	RPC01-3101 Placebo-Placebo n=184 participants at risk Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Placebo n=196 participants at risk Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-3101 Ozanimod-Ozanimod n=443 participants at risk Participants who previously participated in RPC01-3101 and met the eligibility criteria received Ozanimod 1 mg daily	RPC01-202 Ozanimod Open Label n=54 participants at risk Participants who completed at least 1 year of the open-label period of RPC01-202 for ulcerative colitis and met the eligibility criteria received Ozanimod 1 mg daily
Vascular disorders Hypertension	3.3% 6/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	9.2% 18/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	5.6% 25/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	3.7% 2/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Blood and lymphatic system disorders Anaemia	9.2% 17/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	4.1% 8/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	7.2% 32/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	5.6% 3/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Blood and lymphatic system disorders Leukopenia	4.3% 8/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	4.1% 8/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	3.6% 16/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	7.4% 4/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Blood and lymphatic system disorders Lymphopenia	16.8% 31/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	17.3% 34/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	16.3% 72/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	16.7% 9/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Infections and infestations COVID-19	8.2% 15/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	16.8% 33/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	11.3% 50/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	25.9% 14/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Infections and infestations Nasopharyngitis	4.9% 9/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	8.2% 16/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	7.7% 34/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	5.6% 3/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Infections and infestations Upper respiratory tract infection	4.3% 8/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	7.7% 15/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	4.5% 20/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	0.00% 0/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Investigations Alanine aminotransferase increased	9.2% 17/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	8.7% 17/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	6.8% 30/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	3.7% 2/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Investigations Gamma-glutamyltransferase increased	6.0% 11/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	10.2% 20/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	4.5% 20/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	5.6% 3/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Investigations Lymphocyte count decreased	10.3% 19/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	12.8% 25/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	10.8% 48/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	5.6% 3/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Musculoskeletal and connective tissue disorders Arthralgia	8.2% 15/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	5.6% 11/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	6.8% 30/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	1.9% 1/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Nervous system disorders Headache	4.3% 8/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	4.6% 9/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	5.6% 25/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	0.00% 0/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)
Respiratory, thoracic and mediastinal disorders Cough	4.3% 8/184 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	6.1% 12/196 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	3.8% 17/443 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)	3.7% 2/54 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 108 months). SAEs and Other AEs were assessed from first dose through 90 days following last dose of study treatment (Up to approximately 92 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER