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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02447302
Registration number
NCT02447302
Ethics application status
Date submitted
13/05/2015
Date registered
18/05/2015
Titles & IDs
Public title
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
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Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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2015-001942-28
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Secondary ID [2]
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APD334-003
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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
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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
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
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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
Experimental: Etrasimod Low Dose - Oral, low dose, daily for 12 Weeks
Experimental: Etrasimod High Dose - Oral, high dose, daily for 12 weeks
Placebo comparator: Placebo - Oral, placebo, daily for 12 weeks.
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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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Change From Baseline in Adapted Mayo Score (MCS) at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [1]
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Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Change From Baseline in 2-component MCS at Week 12
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Assessment method [2]
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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. Multiple imputation method was used to handle missing data.
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [3]
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Change From Baseline in Total Mayo Score (TMS) at Week 12
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and Week 12
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Eligibility
Key inclusion criteria
* Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
* Evidence of colonic ulcerative colitis activity on endoscopy
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Minimum age
18
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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
* Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
* Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
* Any prior exposure to natalizumab, efalizumab, or rituximab
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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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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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The people analysing the results/data
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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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Type of endpoint/s
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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
15/10/2015
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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
14/02/2018
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Sample size
Target
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Accrual to date
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Final
156
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Recruitment in Australia
Recruitment state(s)
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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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Recruitment postcode(s) [2]
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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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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Arena Pharmaceuticals
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Address
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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 is a safe and effective treatment for ulcerative colitis.
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Trial website
https://clinicaltrials.gov/study/NCT02447302
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Trial related presentations / publications
Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kuhbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panes J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.
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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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Arena Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/02/NCT02447302/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/02/NCT02447302/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02447302