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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03950232




Registration number
NCT03950232
Ethics application status
Date submitted
13/05/2019
Date registered
15/05/2019

Titles & IDs
Public title
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Scientific title
An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
C5041012
Secondary ID [2] 0 0
APD334-303
Universal Trial Number (UTN)
Trial acronym
ELEVATE UC OLE
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(has expanded access)
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and Severity of Safety Measures
Timepoint [1] 0 0
Up to approximately 8 years
Secondary outcome [1] 0 0
Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
Timepoint [1] 0 0
Week 52 and Week 104
Secondary outcome [2] 0 0
Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry
Timepoint [2] 0 0
Week 52 and Week 104
Secondary outcome [3] 0 0
Change From Baseline in the Total Mayo Score
Timepoint [3] 0 0
Baseline, Week 52, and Week 104
Secondary outcome [4] 0 0
Change From Baseline in Partial Mayo Score
Timepoint [4] 0 0
Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260
Secondary outcome [5] 0 0
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
Timepoint [5] 0 0
Week 52 and Week 104
Secondary outcome [6] 0 0
Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores
Timepoint [6] 0 0
Week 52 and Week 104

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
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/06/2029
Actual
Sample size
Target
Accrual to date
Final
778
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Bankstown-Lidcombe Hospital - Sydney
Recruitment hospital [3] 0 0
Queensland Respiratory Services - Birtinya
Recruitment hospital [4] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [5] 0 0
Dr Mark De Wet - Buderim
Recruitment hospital [6] 0 0
Coral Sea Clinical Research Institute Pty.Ltd - Mackay
Recruitment hospital [7] 0 0
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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St.Petersburg
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Russian Federation
State/province [223] 0 0
Stavropol
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Yaroslavl
Country [225] 0 0
Serbia
State/province [225] 0 0
Belgrade
Country [226] 0 0
Serbia
State/province [226] 0 0
Sremska Mitrovica
Country [227] 0 0
Slovakia
State/province [227] 0 0
Banska Bystrica
Country [228] 0 0
Slovakia
State/province [228] 0 0
Bardejov
Country [229] 0 0
Slovakia
State/province [229] 0 0
Kosice
Country [230] 0 0
Slovakia
State/province [230] 0 0
Levice
Country [231] 0 0
Slovakia
State/province [231] 0 0
Lipany
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Slovakia
State/province [232] 0 0
Nitra
Country [233] 0 0
Slovakia
State/province [233] 0 0
Presov
Country [234] 0 0
Slovakia
State/province [234] 0 0
Sahy
Country [235] 0 0
Slovakia
State/province [235] 0 0
Vranov nad Toplou
Country [236] 0 0
South Africa
State/province [236] 0 0
Gauteng
Country [237] 0 0
South Africa
State/province [237] 0 0
Western CAPE
Country [238] 0 0
South Africa
State/province [238] 0 0
Centurion
Country [239] 0 0
Spain
State/province [239] 0 0
Comunidad Valenciana
Country [240] 0 0
Spain
State/province [240] 0 0
Alicante
Country [241] 0 0
Spain
State/province [241] 0 0
Madrid
Country [242] 0 0
Thailand
State/province [242] 0 0
Bangkok
Country [243] 0 0
Turkey
State/province [243] 0 0
Ankara
Country [244] 0 0
Turkey
State/province [244] 0 0
Antalya
Country [245] 0 0
Turkey
State/province [245] 0 0
Bursa
Country [246] 0 0
Turkey
State/province [246] 0 0
Kocaeli
Country [247] 0 0
Ukraine
State/province [247] 0 0
Dnipro
Country [248] 0 0
Ukraine
State/province [248] 0 0
Ivano-Frankivsk
Country [249] 0 0
Ukraine
State/province [249] 0 0
Kharkiv
Country [250] 0 0
Ukraine
State/province [250] 0 0
Kherson
Country [251] 0 0
Ukraine
State/province [251] 0 0
Kyiv
Country [252] 0 0
Ukraine
State/province [252] 0 0
Lviv
Country [253] 0 0
Ukraine
State/province [253] 0 0
Odesa
Country [254] 0 0
Ukraine
State/province [254] 0 0
Uzhgorod
Country [255] 0 0
Ukraine
State/province [255] 0 0
Vinnytsia
Country [256] 0 0
Ukraine
State/province [256] 0 0
Vinnytsya
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Somerset
Country [258] 0 0
United Kingdom
State/province [258] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arena is a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03950232