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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/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
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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
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Secondary ID [1]
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2018-003986-33
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Secondary ID [2]
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APD334-302
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Universal Trial Number (UTN)
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Trial acronym
ELEVATE UC 12
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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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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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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
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
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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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Percentage of Participants Achieving Clinical Remission
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Assessment method [1]
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Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants Achieving Endoscopic Improvement
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Assessment method [1]
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Endoscopic improvement was defined as an ES <= 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants Achieving Symptomatic Remission
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Assessment method [2]
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Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants With Mucosal Healing
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Assessment method [3]
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Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Achieving Clinical Response
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Assessment method [4]
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Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a >= 2-point and >= 30 percent (%) decrease from Baseline MMS, and a >= 1-point decrease from Baseline in RB sub-score or an absolute RB sub-score <= 1. Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants Achieving Endoscopic Normalization
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Assessment method [5]
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Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease); higher score indicated more severe disease.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8
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Assessment method [6]
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Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
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Timepoint [6]
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Weeks 2, 4 and 8
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Secondary outcome [7]
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Percentage of Participants Achieving Complete Symptomatic Remission
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Assessment method [7]
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Complete symptomatic remission was defined as an SF sub-score = 0 and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
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Timepoint [7]
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Weeks 2, 4, 8 and 12
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Secondary outcome [8]
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Percentage of Participants Achieving Non-invasive Clinical Response
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Assessment method [8]
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Non-invasive clinical response was defined as a >= 30% decrease from Baseline in composite RB and SF sub-scores, and a >= 1 point decrease from Baseline in RB sub-score or RB sub-score <= 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
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Timepoint [8]
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Weeks 2, 4, 8 and 12
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Secondary outcome [9]
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Percentage of Participants Achieving Symptomatic Response
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Assessment method [9]
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Symptomatic response was defined as a >= 30% decrease from Baseline in composite RB and SF score. The SF sub-score ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
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Timepoint [9]
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Weeks 2, 4, 8 and 12
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Eligibility
Key inclusion criteria
- Diagnosed with ulcerative colitis (UC) = 3 months prior to screening
- Active UC confirmed by endoscopy
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Minimum age
16
Years
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Maximum age
80
Years
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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
- 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
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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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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
The people administering the treatment/s
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 3
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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
15/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/12/2021
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Sample size
Target
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Accrual to date
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Final
354
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [2]
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Nepean Hospital - Kingswood
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Coastal Digestive Health - Maroochydore
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Coral Sea Clinical Research Institute - North Mackay
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Footscray Hospital - Footscray
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Austin Health - Heidelberg
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Royal Melbourne Hospital - Parkville
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Liverpool Hospital - Liverpool
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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2747 - Kingswood
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4558 - Maroochydore
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4740 - North Mackay
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3011 - Footscray
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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3050 - Parkville
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2170 - Liverpool
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Recruitment postcode(s) [9]
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3004 - Melbourne
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Recruitment outside Australia
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State/province [104]
0
0
Rajasthan
Query!
Country [105]
0
0
India
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State/province [105]
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0
Uttar Pradesh
Query!
Country [106]
0
0
Israel
Query!
State/province [106]
0
0
Afula
Query!
Country [107]
0
0
Israel
Query!
State/province [107]
0
0
Haifa
Query!
Country [108]
0
0
Israel
Query!
State/province [108]
0
0
Holon
Query!
Country [109]
0
0
Israel
Query!
State/province [109]
0
0
Jerusalem
Query!
Country [110]
0
0
Israel
Query!
State/province [110]
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0
Nahariya
Query!
Country [111]
0
0
Israel
Query!
State/province [111]
0
0
Petach Tikva
Query!
Country [112]
0
0
Israel
Query!
State/province [112]
0
0
Ramat Gan
Query!
Country [113]
0
0
Israel
Query!
State/province [113]
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0
Rehovot
Query!
Country [114]
0
0
Italy
Query!
State/province [114]
0
0
Bari
Query!
Country [115]
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0
Italy
Query!
State/province [115]
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0
Milano
Query!
Country [116]
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0
Italy
Query!
State/province [116]
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Verona
Query!
Country [117]
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Italy
Query!
State/province [117]
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Bologna
Query!
Country [118]
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Italy
Query!
State/province [118]
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Brescia
Query!
Country [119]
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Italy
Query!
State/province [119]
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Catania
Query!
Country [120]
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0
Italy
Query!
State/province [120]
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0
Catanzaro
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Firenze
Query!
Country [122]
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0
Italy
Query!
State/province [122]
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0
Modena
Query!
Country [123]
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0
Italy
Query!
State/province [123]
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Roma
Query!
Country [124]
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0
Italy
Query!
State/province [124]
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Torino
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Country [125]
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Italy
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State/province [125]
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Vicenza
Query!
Country [126]
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Japan
Query!
State/province [126]
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Aichi
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Country [127]
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Japan
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State/province [127]
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Aomori-ken
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Country [128]
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Japan
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Aomori
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Country [129]
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Japan
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Chiba
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Country [130]
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Japan
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Ehime
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Country [131]
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Japan
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Fukuoka
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Country [132]
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Japan
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State/province [132]
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Fukushima
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Country [133]
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Japan
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State/province [133]
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Gifu
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Country [134]
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Japan
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State/province [134]
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Gunma
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Country [135]
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Japan
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State/province [135]
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Hiroshima-Ken
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Japan
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Hiroshima
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Country [137]
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Japan
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State/province [137]
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Hokkaido
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Country [138]
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Japan
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Ibaraki
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Country [139]
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Japan
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Ishikawa
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Country [140]
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Japan
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State/province [140]
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Iwate
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Country [141]
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Japan
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State/province [141]
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Kagawa
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Country [142]
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Japan
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State/province [142]
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Kagoshima
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Country [143]
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Japan
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State/province [143]
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Kanagawa-Ken
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Country [144]
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Japan
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Kanagawa
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Country [145]
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Japan
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Kumamoto
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Country [146]
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Japan
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Kyoto
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Country [147]
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Japan
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State/province [147]
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Mie-Ken
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Country [148]
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Japan
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State/province [148]
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Mie
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Country [149]
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Japan
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State/province [149]
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Miyagi
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Country [150]
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Japan
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State/province [150]
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Nara
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Country [151]
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Japan
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State/province [151]
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Niigata
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Country [152]
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Japan
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Osaka
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Japan
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State/province [153]
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Saga-ken
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Country [154]
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Japan
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State/province [154]
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Saitama-Ken
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Country [155]
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Japan
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State/province [155]
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Shiga-ken
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Country [156]
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Japan
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State/province [156]
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Tokyo
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Country [157]
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Japan
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State/province [157]
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Toyama
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Country [158]
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Japan
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State/province [158]
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Wakayama-ken
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Country [159]
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Korea, Republic of
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State/province [159]
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Daegu
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Country [160]
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Korea, Republic of
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State/province [160]
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Gangwon-do
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Country [161]
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Korea, Republic of
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State/province [161]
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Gyeonggi-do
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Country [162]
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Korea, Republic of
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State/province [162]
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Seodaemun-gu
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Country [163]
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Korea, Republic of
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Busan
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Country [164]
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Lebanon
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State/province [164]
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Beirut
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Lithuania
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State/province [165]
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Panevezys
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Lithuania
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State/province [166]
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Vilnius
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Mexico
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State/province [167]
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Guanajuato
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Mexico
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Jalisco
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Mexico
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State/province [169]
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Nuevo León
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Country [170]
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Mexico
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Chihuahua
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Country [171]
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Mexico
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State/province [171]
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Veracruz
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Country [172]
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Moldova, Republic of
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State/province [172]
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Chisinau
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Netherlands
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State/province [173]
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Geleen
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Country [174]
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Netherlands
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State/province [174]
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Nijmegen
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Country [175]
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Netherlands
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State/province [175]
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Tilburg
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Country [176]
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Poland
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State/province [176]
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Bedzin
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Country [177]
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Poland
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State/province [177]
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Bialystok
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Country [178]
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Poland
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State/province [178]
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Czestochowa
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Country [179]
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Poland
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State/province [179]
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Jelenia Gora
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Country [180]
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Poland
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Kraków
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Country [181]
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Poland
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Lodz
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Country [182]
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Poland
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State/province [182]
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Nowy Targ
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Country [183]
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0
Poland
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State/province [183]
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Oswiecim
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Country [184]
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Poland
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State/province [184]
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Poznan
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Country [185]
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0
Poland
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State/province [185]
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Rzeszow
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Country [186]
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0
Poland
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State/province [186]
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Sopot
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Country [187]
0
0
Poland
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State/province [187]
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Swidnica
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Country [188]
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Poland
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Szczecin
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Poland
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Warsaw
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Poland
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Wroclaw
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Portugal
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Braga
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Country [192]
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Portugal
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State/province [192]
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Coimbra
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Country [193]
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Portugal
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State/province [193]
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Guimarães
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Country [194]
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0
Portugal
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State/province [194]
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Lisboa
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Country [195]
0
0
Portugal
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State/province [195]
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Porto
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Country [196]
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Portugal
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State/province [196]
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Vila Nova de Gaia
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Country [197]
0
0
Romania
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State/province [197]
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Bucharest
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Country [198]
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Romania
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State/province [198]
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Bucuresti
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Country [199]
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Country [201]
0
0
Romania
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Oradea
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Country [202]
0
0
Russian Federation
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0
Barnaul
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Country [203]
0
0
Russian Federation
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State/province [203]
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0
Izhevsk
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Country [204]
0
0
Russian Federation
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State/province [204]
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Kazan
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Country [205]
0
0
Russian Federation
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State/province [205]
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Kemerovo
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Country [206]
0
0
Russian Federation
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State/province [206]
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0
Nizhniy Novgorod
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Country [207]
0
0
Russian Federation
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State/province [207]
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0
Novosibirsk
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Country [208]
0
0
Russian Federation
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State/province [208]
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Omsk
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Country [209]
0
0
Russian Federation
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State/province [209]
0
0
Penza
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Country [210]
0
0
Russian Federation
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State/province [210]
0
0
Saint-Peterburg
Query!
Country [211]
0
0
Russian Federation
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State/province [211]
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0
Saint-Petersburg
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Country [212]
0
0
Russian Federation
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State/province [212]
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0
Samara
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Country [213]
0
0
Russian Federation
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State/province [213]
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0
Sestroretsk
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Country [214]
0
0
Russian Federation
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State/province [214]
0
0
Smolensk
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Country [215]
0
0
Russian Federation
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State/province [215]
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0
Stavropol
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Country [216]
0
0
Russian Federation
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State/province [216]
0
0
Yaroslavl
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Country [217]
0
0
Serbia
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State/province [217]
0
0
Belgrade
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Country [218]
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0
Serbia
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State/province [218]
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0
Kragujevac
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Country [219]
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Serbia
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State/province [219]
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0
Sremska Mitrovica
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Country [220]
0
0
Slovakia
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State/province [220]
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0
Presov
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Country [221]
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0
Slovakia
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State/province [221]
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0
Banska Bystrica
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Country [222]
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0
Slovakia
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State/province [222]
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Bardejov
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Country [223]
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0
Slovakia
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State/province [223]
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0
Nitra
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Country [224]
0
0
Slovakia
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State/province [224]
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0
Sahy
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Country [225]
0
0
Slovakia
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State/province [225]
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0
Zilina
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Country [226]
0
0
South Africa
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State/province [226]
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0
Centurion
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Country [227]
0
0
South Africa
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State/province [227]
0
0
Gauteng
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Country [228]
0
0
South Africa
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State/province [228]
0
0
Western Cape
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Country [229]
0
0
Spain
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State/province [229]
0
0
Alicante
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Country [230]
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0
Spain
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State/province [230]
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0
Barcelona
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Country [231]
0
0
Spain
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State/province [231]
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0
Las Palmas
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Country [232]
0
0
Spain
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State/province [232]
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0
Madrid
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Country [233]
0
0
Switzerland
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State/province [233]
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0
Baden
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Country [234]
0
0
Switzerland
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State/province [234]
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0
Bern
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Country [235]
0
0
Thailand
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State/province [235]
0
0
Bangkok
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Country [236]
0
0
Turkey
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State/province [236]
0
0
Yenimahalle/Ankara
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Country [237]
0
0
Turkey
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State/province [237]
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0
Ankara
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Country [238]
0
0
Turkey
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State/province [238]
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0
Antalya
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Country [239]
0
0
Turkey
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State/province [239]
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0
Kocaeli
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Country [240]
0
0
Turkey
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State/province [240]
0
0
Trabzon
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Country [241]
0
0
Ukraine
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State/province [241]
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0
Dnipro
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Country [242]
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0
Ukraine
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State/province [242]
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0
Ivano-Frankivsk
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Country [243]
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0
Ukraine
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State/province [243]
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0
Kharkiv
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Country [244]
0
0
Ukraine
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State/province [244]
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0
Kherson
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Country [245]
0
0
Ukraine
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State/province [245]
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0
Kremenchuk
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Country [246]
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0
Ukraine
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State/province [246]
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0
Kyiv
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Country [247]
0
0
Ukraine
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State/province [247]
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Lviv
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Country [248]
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0
Ukraine
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State/province [248]
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0
Odesa
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Country [249]
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Ukraine
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State/province [249]
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0
Uzhgorod
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Country [250]
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0
Ukraine
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State/province [250]
0
0
Vinnytsia
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Country [251]
0
0
United Kingdom
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State/province [251]
0
0
Greater London
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Country [252]
0
0
United Kingdom
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State/province [252]
0
0
Norfolk
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Country [253]
0
0
United Kingdom
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State/province [253]
0
0
Somerset
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Arena Pharmaceuticals
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Address
Query!
Country
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Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03996369
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Arena CT.gov Administrator
Query!
Address
0
0
Arena Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03996369
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