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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02536404
Registration number
NCT02536404
Ethics application status
Date submitted
24/08/2015
Date registered
31/08/2015
Date last updated
26/11/2021
Titles & IDs
Public title
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
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Scientific title
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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0
APD334-005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo
Experimental: Etrasimod 2 mg -
Active Comparator: Placebo -
Treatment: Drugs: Etrasimod
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Week 48 (up to 30 days following discontinuation of the study drug)
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Secondary outcome [1]
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Proportion of Participants Who Achieved Clinical Response
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Assessment method [1]
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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.
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Timepoint [1]
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Week 46 (extension study APD334-005)
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Secondary outcome [2]
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Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005
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Assessment method [2]
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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.
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Timepoint [2]
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Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)
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Secondary outcome [3]
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Proportion of Participants Who Achieved Clinical Remission
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Assessment method [3]
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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.
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Timepoint [3]
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Week 46 (extension study APD334-005)
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Secondary outcome [4]
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Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005
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Assessment method [4]
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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.
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Timepoint [4]
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Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)
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Eligibility
Key inclusion criteria
- Participants who completed the APD334-003 (NCT02447302) study
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants who did not complete the APD334-003 study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Blinded (masking used)
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/01/2016
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
1/11/2018
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Sample size
Target
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Accrual to date
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Final
118
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Recruitment in Australia
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Recruitment hospital [1]
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Arena 1604 - Kingswood
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Arena 1605 - Randwick
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Arena 1607 - Subiaco
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2747 - Kingswood
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2031 - Randwick
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Recruitment postcode(s) [3]
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6008 - Subiaco
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Recruitment outside Australia
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Arena Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective
treatment for ulcerative colitis after 52 weeks of treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02536404
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Arena CT.gov Administrator
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Address
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Arena Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02536404
Download to PDF