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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03996369




Registration number
NCT03996369
Ethics application status
Date submitted
21/06/2019
Date registered
24/06/2019
Date last updated
21/12/2022

Titles & IDs
Public title
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2018-003986-33
Secondary ID [2] 0 0
APD334-302
Universal Trial Number (UTN)
Trial acronym
ELEVATE UC 12
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 12-Week Induction Treatment Period

Treatment: Drugs: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Improvement
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving Symptomatic Remission
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Mucosal Healing
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Clinical Response
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving Endoscopic Normalization
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8
Timepoint [6] 0 0
Weeks 2, 4 and 8
Secondary outcome [7] 0 0
Percentage of Participants Achieving Complete Symptomatic Remission
Timepoint [7] 0 0
Weeks 2, 4, 8 and 12
Secondary outcome [8] 0 0
Percentage of Participants Achieving Non-invasive Clinical Response
Timepoint [8] 0 0
Weeks 2, 4, 8 and 12
Secondary outcome [9] 0 0
Percentage of Participants Achieving Symptomatic Response
Timepoint [9] 0 0
Weeks 2, 4, 8 and 12

Eligibility
Key inclusion criteria
* Diagnosed with ulcerative colitis (UC) = 3 months prior to screening
* 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
* Severe extensive colitis
* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
* 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/12/2021
Sample size
Target
Accrual to date
Final
354
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 - Maroochydore
Recruitment hospital [4] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [5] 0 0
Footscray Hospital - Footscray
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [9] 0 0
Alfred Hospital - Melbourne
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
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
2170 - Liverpool
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
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State/province [253] 0 0
Somerset

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 assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
Trial website
https://clinicaltrials.gov/study/NCT03996369
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03996369