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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03945188
Ethics application status
Date submitted
8/05/2019
Date registered
10/05/2019

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
Percentage of Participants Achieving Clinical Remission at Week 12
Timepoint [1] 0 0
At Week 12
Primary outcome [2] 0 0
Percentage of Participants Achieving Clinical Remission at Week 52
Timepoint [2] 0 0
At Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Improvement at Week 12
Timepoint [1] 0 0
At Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving Endoscopic Improvement at Week 52
Timepoint [2] 0 0
At Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving Symptomatic Remission at Week 12
Timepoint [3] 0 0
At Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Symptomatic Remission at Week 52
Timepoint [4] 0 0
At Week 52
Secondary outcome [5] 0 0
Percentage of Participants With Mucosal Healing at Week 12
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Percentage of Participants With Mucosal Healing at Week 52
Timepoint [6] 0 0
At Week 52
Secondary outcome [7] 0 0
Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52
Timepoint [7] 0 0
At Week 52
Secondary outcome [8] 0 0
Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52
Timepoint [8] 0 0
At Weeks 12 and 52
Secondary outcome [9] 0 0
Percentage of Participants Achieving Clinical Response at Week 12
Timepoint [9] 0 0
At Week 12
Secondary outcome [10] 0 0
Percentage of Participants Achieving Clinical Response at Week 52
Timepoint [10] 0 0
At Week 52
Secondary outcome [11] 0 0
Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52
Timepoint [11] 0 0
At Weeks 12 and 52
Secondary outcome [12] 0 0
Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52
Timepoint [12] 0 0
At Weeks 12 and 52
Secondary outcome [13] 0 0
Percentage of Participants Achieving Endoscopic Normalization at Week 12
Timepoint [13] 0 0
At Week 12
Secondary outcome [14] 0 0
Percentage of Participants Achieving Endoscopic Normalization at Week 52
Timepoint [14] 0 0
At Week 52
Secondary outcome [15] 0 0
Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52
Timepoint [15] 0 0
At Weeks 12 and 52
Secondary outcome [16] 0 0
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Timepoint [16] 0 0
At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48
Secondary outcome [17] 0 0
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Timepoint [17] 0 0
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52
Secondary outcome [18] 0 0
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Timepoint [18] 0 0
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Secondary outcome [19] 0 0
Percentage of Participants Achieving Symptomatic Response by Study Visit
Timepoint [19] 0 0
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Secondary outcome [20] 0 0
Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline
Timepoint [20] 0 0
At Week 52
Secondary outcome [21] 0 0
Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12
Timepoint [21] 0 0
At 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
Sex
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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/02/2022
Sample size
Target
Accrual to date
Final
433
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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Uzhgorod
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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Greater London
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Norfolk
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United Kingdom
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Somerset
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United Kingdom
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Belfast
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United Kingdom
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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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arena CT.gov Administrator
Address 0 0
Arena Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03945188