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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/NCT03950232
Registration number
NCT03950232
Ethics application status
Date submitted
13/05/2019
Date registered
15/05/2019
Date last updated
3/06/2024
Titles & IDs
Public title
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
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Scientific title
An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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C5041012
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Secondary ID [2]
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APD334-303
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Universal Trial Number (UTN)
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Trial acronym
ELEVATE UC OLE
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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
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0
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0
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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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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Experimental: Etrasimod 2 mg -
Treatment: Drugs: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first
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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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Number and Severity of Safety Measures
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Assessment method [1]
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Safety as assessed by the evaluation of adverse events
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Timepoint [1]
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Up to approximately 8 years
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Secondary outcome [1]
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Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
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Assessment method [1]
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Timepoint [1]
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Week 52 and Week 104
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Secondary outcome [2]
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Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry
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Assessment method [2]
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Timepoint [2]
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Week 52 and Week 104
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Secondary outcome [3]
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Change From Baseline in the Total Mayo Score
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Assessment method [3]
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The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.
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Timepoint [3]
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Baseline, Week 52, and Week 104
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Secondary outcome [4]
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Change From Baseline in Partial Mayo Score
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Assessment method [4]
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The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.
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Timepoint [4]
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Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260
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Secondary outcome [5]
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Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
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Assessment method [5]
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Timepoint [5]
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Week 52 and Week 104
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Secondary outcome [6]
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Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores
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Assessment method [6]
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Timepoint [6]
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Week 52 and Week 104
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Eligibility
Key inclusion criteria
- Must have met the eligibility criteria and have been enrolled in the qualified Phase 2
or 3 parent studies listed below or other qualified region-specific studies and meet
the following additional criteria:
1. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210
(NCT04607837) must have completed the Week 12 visit and have been assessed to
have active UC that has not improved or has worsened from baseline or completed
the Week 52 visit
2. Participants previously enrolled in APD334-302 (NCT03996369) must have completed
the Week 12 visit
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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
- If Investigator considers the participant to be unsuitable for any reason to
participate in the Open-Label Extension study
- Experienced an adverse event that led to discontinuation from parent study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Recruiting
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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
5/09/2019
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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
21/07/2026
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Actual
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Sample size
Target
912
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Liverpool Hospital - Liverpool
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Bankstown-Lidcombe Hospital - Sydney
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Queensland Respiratory Services - Birtinya
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Sunshine Coast University Private Hospital - Birtinya
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Dr Mark De Wet - Buderim
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Coral Sea Clinical Research Institute Pty.Ltd - Mackay
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Dr Shiran DeSilva Respiratory Clinic - Mackay
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Mackay Discount Drug Store - Mackay
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Mater Misericordiae Hospital - Mackay
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Queensland X-Ray - Mackay
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Vision Eye Institute Mackay - Mackay
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Coastal Digestive Helath Pty. Ltd - Maroochydore
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Austin Health - Heidelberg
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The Alfred Hospital - Melbourne
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The Royal Melbourne Hospital - Parkville
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2170 - Liverpool
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2200 - Sydney
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4575 - Birtinya
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4556 - Buderim
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4740 - Mackay
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4558 - Maroochydore
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3084 - Heidelberg
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3004 - Melbourne
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3050 - Parkville
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Gifu
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Japan
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Gunma
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Ibaraki
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Japan
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Ishikawa
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Japan
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Iwate
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Japan
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Kagawa
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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MIE
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saga
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Japan
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Saitama
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Japan
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Shiga
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Wakayama
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Japan
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Yamanashi
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Japan
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Fukushima
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Japan
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Hirakata-city
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Korea, Republic of
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Gangwon-do
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Korea, Republic of
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Gangwon-du
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Lebanon
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Beirut
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Lithuania
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Panevezys
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Lithuania
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Vilnius
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Nuevo LEON
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Mexico
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Chihuahua
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Mexico
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Veracruz
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Moldova, Republic of
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Chisinau
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Poland
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Wielkopolskie
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Poland
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Bedzin
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Poland
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Bialystok
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Poland
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Bystra
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Poland
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Dabrowa Gomicza
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Poland
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Dzierzoniow
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Jelenia Gora
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Poland
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Katowice
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Poland
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Lodz
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Poland
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Nowy Targ
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Poland
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Oswiecim
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Poland
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Poznan
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Poland
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Rzeszow
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Poland
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Sopot
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Poland
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Strzegom
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Poland
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Swidnica
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Poland
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Zakopane
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Portugal
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Porto
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Portugal
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Coimbra
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Portugal
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Guimaraes
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Portugal
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Vila Nova de Gaia
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Romania
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Bihor
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Romania
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Cluj
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Romania
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District 1
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Country [192]
0
0
Romania
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District 2
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Country [193]
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0
Romania
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Sector 1
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Russian Federation
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Altayskiy Region
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0
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Russian Federation
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Samara Region
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Russian Federation
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Stavropol Region
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Russian Federation
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Irkutsk
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Russian Federation
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Izhevsk
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Russian Federation
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Kemerovo
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Penza
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Country [206]
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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Smolensk
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Country [210]
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Russian Federation
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St. Petersburg
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Russian Federation
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St.Petersburg
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Russian Federation
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Stavropol
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0
Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Sremska Mitrovica
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Slovakia
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Banska Bystrica
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Slovakia
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Bardejov
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Slovakia
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Kosice
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Slovakia
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Levice
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Slovakia
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Lipany
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Slovakia
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Nitra
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Slovakia
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Presov
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Slovakia
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Sahy
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Slovakia
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Vranov nad Toplou
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South Africa
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Gauteng
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South Africa
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Western CAPE
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South Africa
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Centurion
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Spain
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Alicante
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Spain
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Madrid
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Thailand
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Bangkok
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Turkey
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Ankara
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Country [232]
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Turkey
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Antalya
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Turkey
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Bursa
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Turkey
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Kocaeli
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Country [235]
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Ukraine
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Dnipro
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kyiv
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Country [240]
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
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Country [244]
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United Kingdom
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Somerset
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United Kingdom
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0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
Arena is a wholly owned subsidiary of Pfizer
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Address [1]
0
0
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Country [1]
0
0
Query!
Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy
of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who
previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during
participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled
parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302
[NCT03996369] or APD334-210 [NCT04607837]).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03950232
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-800-718-1021
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03950232
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