Extension Study of APD334-003 in Patients With Moderately... | NCT02536404

NCT02536404

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Etrasimod 2 mg	Experimental		Drug: Etrasimod
Placebo	Active Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Etrasimod	Drug		Etrasimod 2 mg	APD334
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)	A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	Up to Week 48 (up to 30 days following discontinuation of the study drug)

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Participants Who Achieved Clinical Response	A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Etrasimod 2 mg	Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.
FG001	Placebo	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.

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	Oct 29, 2021

Arm/Group Information

ID	Title	Description
BG000	Etrasimod 2 mg	Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.
BG001	Placebo	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
BG002	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

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00043.7± 13.25 BG00150.2± 13.93 BG00244.0± 13.30

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00044 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)

A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.

Safety Population: All randomized participants who received study medication in the extension study APD334-005

Posted

Count of Participants

Participants

Up to Week 48 (up to 30 days following discontinuation of the study drug)

ID	Title	Description
OG000	Etrasimod 2 mg	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.
OG001	Placebo	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.

Units	Counts
Participants	OG000112 OG0016

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG00067 OG0015

Treatment-emergent SAEs

Title	Measurements
	OG000

Secondary

Proportion of Participants Who Achieved Clinical Response

A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

Completers Population Evaluable Cohort: All participants who received at least 1 dose of etrasimod or placebo and completed the extension study APD334-005

Posted

Number

90% Confidence Interval

Percentage of participants

Week 46 (extension study APD334-005)

ID	Title	Description
OG000	Etrasimod 2 mg	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.
OG001	Placebo	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.

Secondary

Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005

Completers Population Evaluable Cohort

Posted

Number

90% Confidence Interval

Percentage of participants

Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

ID	Title	Description
OG000	Etrasimod 2 mg	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.
OG001	Placebo	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.

Secondary

Proportion of Participants Who Achieved Clinical Remission

A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

Completers Population Evaluable Cohort

Posted

Number

90% Confidence Interval

Percentage of participants

Week 46 (extension study APD334-005)

ID	Title	Description
OG000	Etrasimod 2 mg	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.
OG001	Placebo	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.

Units	Counts
Participants	OG000

Secondary

Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005

Completers Population Evaluable Cohort

Posted

Number

90% Confidence Interval

Percentage of participants

Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

ID	Title	Description
OG000	Etrasimod 2 mg	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.
OG001	Placebo	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.

Units	Counts
Participants

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	Etrasimod 2 mg	Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.	0	112	7	112	66	112
EG001	Placebo	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.	0	6	0	6	5	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDra 20.1	Systematic Assessment	EG0002 affected112 at risk EG0010 affected6 at risk
Atrial fibrillation	Cardiac disorders	MedDra 20.1	Systematic Assessment	EG0001 affected112 at risk EG0010 affected6 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDra 20.1	Systematic Assessment	EG0003 affected112 at risk EG0010 affected6 at risk
Large intestine perforation	Gastrointestinal disorders	MedDra 20.1	Systematic Assessment	EG0001 affected112 at risk EG0010 affected6 at risk
Pancreatitis	Gastrointestinal disorders	MedDra 20.1	Systematic Assessment	EG0001 affected112 at risk EG0010 affected6 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDra 20.1	Systematic Assessment	EG0001 affected112 at risk EG0010 affected6 at risk
Gastroenteritis	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0001 affected112 at risk EG0010 affected6 at risk
Fine motor skill dysfunction	Nervous system disorders	MedDra 20.1	Systematic Assessment	EG0001 affected112 at risk EG0010 affected6 at risk
Transient ischaemic attack	Nervous system disorders	MedDra 20.1	Systematic Assessment	EG0001 affected112 at risk EG0010 affected6 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDra 20.1	Systematic Assessment	EG0001 affected112 at risk EG0010 affected6 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG00010 affected112 at risk EG0010 affected6 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 affected112 at risk EG0010 affected6 at risk
Faecal calprotectin increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 affected112 at risk EG0011 affected6 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 affected112 at risk EG0010 affected6 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG00010 affected112 at risk EG0010 affected6 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected112 at risk EG0010 affected6 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected112 at risk EG0010 affected6 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected112 at risk EG0011 affected6 at risk
Vitreous	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00016 affected112 at risk EG0011 affected6 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected112 at risk EG0011 affected6 at risk
Dental caries	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Premenstrual headache	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected112 at risk EG0012 affected6 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0006 affected112 at risk EG0012 affected6 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0007 affected112 at risk EG0010 affected6 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected112 at risk EG0010 affected6 at risk
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Chronic sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 at risk
Herpes zoster	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected112 at risk EG0011 affected6 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected112 at risk EG0011 affected6 at risk
Tooth infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected112 at risk EG0011 affected6 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