Safety and Efficacy of Etrasimod (APD334) in Patients Wit... | NCT02447302

ID	Type	Description	Link
2015-001942-28	EudraCT Number

Status Module

Oversight 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
Etrasimod Low Dose	Experimental	Oral, low dose, daily for 12 Weeks	Drug: Etrasimod
Etrasimod High Dose	Experimental	Oral, high dose, daily for 12 weeks	Drug: Etrasimod
Placebo	Placebo Comparator	Oral, placebo, daily for 12 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Etrasimod	Drug		Etrasimod High Dose Etrasimod Low Dose	APD334

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Adapted Mayo Score (MCS) at Week 12	The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.	Baseline and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12	For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.

Other Outcomes

Measure	Description	Time Frame
Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12	The trichotomous composite score of clinical remission and clinical response at Week 12 is an ordinal categorical endpoint with 3 categories (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response, and 0 for achieving neither). Multiple imputation method was used to handle missing data.

Eligibility Module

Name	Affiliation	Role
Arena CT.gov Administrator	Arena Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arena 1119		Birmingham	Alabama	35294	United States
Arena 1133

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39778975	Derived	Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.
39526078

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
FG001	Etrasimod 2 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 3, 2017	Feb 12, 2021

Arm/Group Information

ID	Title	Description
BG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
BG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
BG002	Placebo	Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
BG003	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, Continuous

Median

Full Range

years

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00150 ParticipantsBG00254 ParticipantsBG003

Age, Customized

Number

Subjects

Title	Denominators	Categories
Adults (18-64 years)	ParticipantsBG00052 ParticipantsBG00150 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00150 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00150 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00150 ParticipantsBG002

Adapted Mayo Score (MCS)

The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease.

The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.

Mean

Standard Deviation

score on a scale

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG001

The 2-component MCS

The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease.

The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.

Mean

Standard Deviation

score on a scale

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG001

Total Mayo Score (TMS)

The TMS consisted of 4 subscores [stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease.

The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.

Mean

Standard Deviation

score on a scale

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG001

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

Change From Baseline in Adapted Mayo Score (MCS) at Week 12

The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug.

Posted

Least Squares Mean

90% Confidence Interval

score on a scale

Baseline and Week 12

ID	Title	Description
OG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG002	Placebo	Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.

Units	Counts
Participants	OG00052 OG00150 OG00254

Title

Denominators

Categories

Title	Measurements
	OG000-1.94(-2.45 to -1.42) OG001-2.49(-3.01 to -1.98) OG002-1.50(-2.00 to -1.01)

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
OG001 OG002	The primary comparison in the study was between etrasimod 2 mg versus placebo.	ANCOVA	The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.	= 0.0091	The analysis was performed using an analysis of covariance (ANCOVA) model that incorporated treatment, current oral corticosteroid use, prior exposure to tumor necrosis factor alpha (TNFα) antagonists, and baseline value as covariate.	Difference in least square mean	-0.99	Standard Error of the Mean	0.42	2-Sided	90	-1.68	-0.30			Estimated least square mean difference in etrasimod 2 mg from placebo

Secondary

Percentage of Participants Who Achieved Endoscopic Improvement at Week 12

For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.

The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.

Secondary

Change From Baseline in 2-component MCS at Week 12

The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.

Posted

Least Squares Mean

90% Confidence Interval

score on a scale

Baseline and Week 12

ID	Title	Description
OG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG002	Placebo

Secondary

Change From Baseline in Total Mayo Score (TMS) at Week 12

The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores [stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.

The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.

Posted

Least Squares Mean

90% Confidence Interval

score on a scale

Baseline and Week 12

ID	Title	Description
OG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG002

Other Pre-specified

Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12

The trichotomous composite score of clinical remission and clinical response at Week 12 is an ordinal categorical endpoint with 3 categories (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response, and 0 for achieving neither). Multiple imputation method was used to handle missing data.

The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.

Posted

Mean

Standard Error

score on a scale

Week 12

ID	Title	Description
OG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG002	Placebo	Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.

Other Pre-specified

Percentage of Participants Who Achieved Clinical Remission at Week 12

A participant was considered to have achieved clinical remission if he/she had: 1) an endoscopy score using flexible proctosigmoidoscopy of 0 or 1 (excluding friability), 2) a rectal bleeding score of 0 or 1, and 3) a stool frequency score of 0 or 1 with a decrease of ≥1 point from baseline. Multiple imputation method was used to handle missing data.

The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG002	Placebo	Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.

Other Pre-specified

Percentage of Participants Who Achieved Clinical Response at Week 12

A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission defined above, or met criteria of clinical response. Clinical response was defined as a decrease in the adapted MCS of ≥ 2 points and a decrease of ≥ 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1.

The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
OG002	Placebo	Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Etrasimod 1 mg	Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.	52	3	52	11	52
EG001	Etrasimod 2 mg	Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.	50	0	50	11	50
EG002	Placebo	Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.	54	6	54	9	54

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected52 at risk EG0010 affected50 at risk EG0021 affected54 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected52 at risk EG0010 affected50 at risk EG0023 affected54 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected52 at risk EG0010 affected50 at risk EG0021 affected54 at risk
Jaundice	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected52 at risk EG0010 affected50 at risk EG0021 affected54 at risk
Anal abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected52 at risk EG0010 affected50 at risk EG0020 affected54 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected52 at risk EG0010 affected50 at risk EG0021 affected54 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected52 at risk EG0011 affected50 at risk EG0024 affected54 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 affected52 at risk EG0012 affected50 at risk EG0022 affected54 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected52 at risk EG0012 affected50 at risk EG0021 affected54 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected52 at risk EG0013 affected50 at risk EG0021 affected54 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected52 at risk EG0013 affected50 at risk EG0022 affected54 at risk

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