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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03945188




Registration number
NCT03945188
Ethics application status
Date submitted
8/05/2019
Date registered
10/05/2019
Date last updated
30/10/2020

Titles & IDs
Public title
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2018-003985-15
Secondary ID [2] 0 0
APD334-301
Universal Trial Number (UTN)
Trial acronym
ELEVATE UC 52
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo

Experimental: Etrasimod 2 mg -

Placebo Comparator: Placebo -


Treatment: Drugs: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment

Treatment: Drugs: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of participants With Clinical Remission Assessed by Mayo Component Sub-scores and no Corticosteroid use for = 12 Weeks
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Proportion of Participants With Mucosal Healing Assessed by Geboes Index Scores
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Proportion of Participants With Mucosal Healing Assessed by Geboes Index Scores
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores
Timepoint [6] 0 0
Week 12 and Week 52

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Diagnosed with ulcerative colitis (UC) = 3 months prior to screening

2. Active UC confirmed by endoscopy
Minimum age
16 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Severe extensive colitis

2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history
of a fistula consistent with CD

3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Coastal Digestive Health Pty Ltd - Maroochydore
Recruitment hospital [4] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [5] 0 0
Austin Health Gastroenterology Department - Heidelberg
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
4740 - North Mackay
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3050 - Parkville
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Hemel Hempstead

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arena Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment
for moderately to severely active ulcerative colitis.
Trial website
https://clinicaltrials.gov/show/NCT03945188
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Chris Cabell, MD
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Arena Pharmaceuticals
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Contact person for public queries
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Arena CT.gov Administrator
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855-218-9153
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ct.gov@arenapharm.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03945188