Safety and Efficacy Trial of RPC1063 for Moderate to Seve... | NCT02435992

NCT02435992

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RPC1063 (Ozanimod)	Experimental	1mg, daily oral administration during Induction and Maintenance periods.	Drug: RPC1063
Placebo	Placebo Comparator	Daily oral administration during Induction and Maintenance periods.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
RPC1063	Drug		RPC1063 (Ozanimod)
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants in Clinical Remission at 10 Weeks	Percentage of participants that are in Clinical remission at 10 weeks	At 10 Weeks
Percentage of Participants in Clinical Remission at 52 Weeks	Percentage of participants that are in Clinical remission at 52 weeks	At 52 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinical Response at 10 Weeks	Percentage of participants that are in Clinical response at 10 weeks	At 10 Weeks
Percentage of Participants With Endoscopic Improvement at 10 Weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
AnnKatrin Petersen, M.D., MSc.	Celgene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Digestive Health		Sun City	Arizona	85351	United States
Adobe Clinical Research LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41677183	Derived	Rubin DT, Danese S, Nakase H, Ungaro RC, Wolf DC, Alekseeva O, Petersen A, Liu Z, Mehra D, Jain A, Osterman MT, Krakovich A, Riolo JV, DeBoer E, Appio J, Sinh P, Cree BAC, Cohen JA, Irving P. Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis. Inflamm Bowel Dis. 2026 May 1;32(5):954-962. doi: 10.1093/ibd/izaf319.
41003640

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RPC1063 Cohort 1 (Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 26, 2019	Jun 25, 2021

Arm/Group Information

ID	Title	Description
BG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
BG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
BG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
BG003	RPC1063 (Maintenance Period)	- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
BG004	Placebo (Maintenance Period)	- Blinded Placebo
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Two different periods

Count of Participants

Participants

Title	Denominators	Categories
Induction Period	ParticipantsBG000429 ParticipantsBG001216 ParticipantsBG002367 ParticipantsBG003

Sex: Female, Male

Two different periods

Count of Participants

Participants

Title	Denominators	Categories
Induction Period	ParticipantsBG000429 ParticipantsBG001216 ParticipantsBG002

Ethnicity (NIH/OMB)

Two different periods

Count of Participants

Participants

Title	Denominators	Categories
Induction Period	ParticipantsBG000429 ParticipantsBG001216 ParticipantsBG002

Race (NIH/OMB)

Two different periods

Count of Participants

Participants

Title	Denominators	Categories
Induction Period	ParticipantsBG000429 ParticipantsBG001216 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants in Clinical Remission at 10 Weeks

Percentage of participants that are in Clinical remission at 10 weeks

ITT Population

Posted

Number

Percentage

At 10 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
OG003	RPC1063 (Maintenance Period)	- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
OG004	Placebo (Maintenance Period)	- Blinded Placebo

Units	Counts
Participants	OG000429 OG001216 OG002367 OG003

Title

Denominators

Categories

Title	Measurements
	OG00018.4 OG0016.0 OG00221.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.0001		Odds Ratio (OR)	3.586			2-Sided	95	1.938	6.636					Superiority

Primary

Percentage of Participants in Clinical Remission at 52 Weeks

Percentage of participants that are in Clinical remission at 52 weeks

ITT Population

Posted

Number

Percentage

At 52 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants With Clinical Response at 10 Weeks

Percentage of participants that are in Clinical response at 10 weeks

ITT Population

Posted

Number

Percentage

At 10 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants With Endoscopic Improvement at 10 Weeks

Percentage of participants with endoscopic improvement at 10 weeks

ITT Population

Posted

Number

Percentage

At 10 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants With Mucosal Healing at 10 Weeks

Percentage of participants with mucosal healing at 10 weeks

ITT Population

Posted

Number

Percentage

At 10 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants in Clinical Response at 52 Weeks

Percentage of participants that are in Clinical response at 52 weeks

ITT Population

Posted

Number

Percentage

At 52 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants With Endoscopic Improvement at 52 Weeks

Percentage of participants with endoscopic improvement at 52 weeks

ITT Population

Posted

Number

Percentage

At 52 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10

Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10

ITT Population who were in remission at week 10

Posted

Number

Percentage

At 52 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants With Corticosteroid Free Remission at 52 Weeks

Percentage of participants with corticosteroid free remission at 52 weeks

ITT Population

Posted

Number

Percentage

At 52 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants With Mucosal Healing at 52 Weeks

Percentage of participants with Mucosal Healing at 52 weeks

ITT Population

Posted

Number

Percentage

At 52 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Secondary

Percentage of Participants With Durable Clinical Remission at 52 Weeks

Percentage of participants with durable clinical remission at 52 weeks

ITT Population

Posted

Number

Percentage

At 52 Weeks

ID	Title	Description
OG000	RPC1063 Cohort 1(Induction Period)	Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
OG001	Placebo Cohort 1 (Induction Period)	-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
OG002	RPC1063 Cohort 2 (Induction Period)	Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1 (Induction Period): RPC1063 1mg	Cohort 1 (Induction Period): RPC1063 1mg	0	429	17	429	15	429
EG001	Cohort 1: Placebo	Cohort 1: Placebo	0	216	11	216	13	216
EG002	Cohort 2 (Induction Period): RPC1063 1mg	Cohort 2 (Induction Period): RPC1063 1mg	1	367	23	367	15	367
EG003	Intervention (Maintenance Period): RPC1063 1mg	Intervention (Maintenance Period): RPC1063 1mg	0	230	12	230	2	230
EG004	Placebo (Maintenance Period): Placebo	Placebo (Maintenance Period): Placebo	0	227	18	227	4	227

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0004 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG0031 affected230 at risk EG0040 affected227 at risk
Angina pectoris	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Cataract	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Photophobia	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0006 affected429 at risk EG0015 affected216 at risk EG0029 affected367 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0011 affected216 at risk EG0020 affected367 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0011 affected216 at risk EG0020 affected367 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0011 affected216 at risk EG0020 affected367 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Proctitis ulcerative	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0011 affected216 at risk EG0020 affected367 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Food allergy	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Appendicitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0022 affected367 at risk EG003
Bronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0011 affected216 at risk EG0020 affected367 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Complicated appendicitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0022 affected367 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Large intestine infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0011 affected216 at risk EG0020 affected367 at risk EG003
Measles	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Yersinia infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Neck injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Respiratory syncytial virus test positive	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0011 affected216 at risk EG0021 affected367 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Syncope	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0011 affected216 at risk EG0020 affected367 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0021 affected367 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected429 at risk EG0010 affected216 at risk EG0020 affected367 at risk EG003

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases