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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04173273




Registration number
NCT04173273
Ethics application status
Date submitted
20/11/2019
Date registered
21/11/2019

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
Scientific title
A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
C5041006
Secondary ID [2] 0 0
APD334-202
Universal Trial Number (UTN)
Trial acronym
CULTIVATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo

Experimental: Etrasimod Dose A -

Experimental: Etrasimod Dose B -

Placebo comparator: Placebo -


Treatment: Drugs: Etrasimod
Dose A taken by mouth, once daily.

Treatment: Drugs: Etrasimod
Dose B taken by mouth, once daily.

Treatment: Drugs: Placebo
Etrasimod matching placebo tablet taken by mouth, once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants with Endoscopic Response [Substudy A]
Timepoint [1] 0 0
Weeks 14 and 52
Primary outcome [2] 0 0
Proportion of Participants With Endoscopic Response [Substudy 1]
Timepoint [2] 0 0
Week 14
Primary outcome [3] 0 0
Proportion of Participants With Endoscopic Response [Substudy 2]
Timepoint [3] 0 0
Week 14
Primary outcome [4] 0 0
Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]
Timepoint [4] 0 0
Week 14
Primary outcome [5] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy 3]
Timepoint [5] 0 0
Week 52
Primary outcome [6] 0 0
Proportion of Participants With Endoscopic Response [Substudy 3]
Timepoint [6] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy A]
Timepoint [1] 0 0
Up to Week 66
Secondary outcome [2] 0 0
Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A]
Timepoint [2] 0 0
Baseline to Week 66
Secondary outcome [3] 0 0
Change From Baseline in CDAI Score [Substudy A]
Timepoint [3] 0 0
Baseline to Week 66
Secondary outcome [4] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy 1]
Timepoint [4] 0 0
Week 14
Secondary outcome [5] 0 0
Proportion of Participants with Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 1]
Timepoint [5] 0 0
Week 14
Secondary outcome [6] 0 0
Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2]
Timepoint [6] 0 0
Week 14
Secondary outcome [7] 0 0
Proportion of Participants With Clinical Response CDAI [Substudy 2]
Timepoint [7] 0 0
Week 14
Secondary outcome [8] 0 0
Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2]
Timepoint [8] 0 0
Week 14
Secondary outcome [9] 0 0
Proportion of Participants With Endoscopic Remission [Substudy 2]
Timepoint [9] 0 0
Week 14
Secondary outcome [10] 0 0
Change from baseline in CD-PRO/SS [Substudy 2]
Timepoint [10] 0 0
Week 14
Secondary outcome [11] 0 0
Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3]
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3]
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3]
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Proportion of Participants With Endoscopic Remission [Substudy 3]
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Proportion of Participants With Clinical Remission PRO2 [Substudy 3]
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Proportion of Participants with Clinical Response or Endoscopic Response [Substudy 3]
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4]
Timepoint [17] 0 0
Up to Week 208
Secondary outcome [18] 0 0
Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4]
Timepoint [18] 0 0
Up to Week 208
Secondary outcome [19] 0 0
Number and Severity of Adverse Events
Timepoint [19] 0 0
Up to approximately 70 weeks for Substudy A,approximately 24 weeks for Substudy 1 and 2; 42 weeks for Substudy 3; and 212 weeks for Substudy 4

Eligibility
Key inclusion criteria
Eligibility criteria applicable to all substudies:



* Men or women 18 to 80 years of age,
* Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
* Diagnosed with Crohn's disease (CD) = 3 months
* Have moderately to severely active CD at Screening
* Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to = 1 of the following therapies for the treatment of CD:

1. Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
2. Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6-MP], or methotrexate [MTX])
3. Tumor necrosis factor alpha (TNFa) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
4. Integrin receptor antagonist (eg, vedolizumab)
5. Interleukin -12/-23 antagonist (eg, ustekinumab)
* Females of childbearing potential must be nonpregnant
* Females of childbearing potential and males must use contraception
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of inadequate response (ie, primary non-response) to agents from = 2 classes of biologics marketed for the treatment of CD (ie, TNFa antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
* Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening.
* Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
* Had surgical treatment for intra abdominal abscesses = 8 weeks prior to randomization or surgical treatment for perianal abscesses = 4 weeks prior to randomization.
* Had intestinal resection = 24 weeks prior to randomization or other intra abdominal surgeries = 12 weeks prior to randomization.
* Have an ileostomy or a colostomy.

Inclusion Criteria for Substudy 3:

- Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit

Inclusion Criteria for Substudy 4:

- Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/08/2029
Actual
Sample size
Target
1175
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Macquarie Respiratory Services - Macquarie University
Recruitment hospital [2] 0 0
Macquarie University Hospital Clinical Trials - Macquarie University
Recruitment hospital [3] 0 0
Macquarie University Hospital Pharmacy - Macquarie University
Recruitment hospital [4] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [5] 0 0
MQ Health Ophthalmology - Macquarie University
Recruitment hospital [6] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [8] 0 0
MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons - Bellfield
Recruitment hospital [9] 0 0
The Northern Hospital - Epping
Recruitment hospital [10] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [11] 0 0
Footscray Hospital - Melbourne
Recruitment hospital [12] 0 0
Vision Eye Institute - Melbourne
Recruitment hospital [13] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [14] 0 0
Heidelberg Eye Clinic - Rosanna
Recruitment hospital [15] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [16] 0 0
Lions Eye Institute Limited - Nedlands
Recruitment hospital [17] 0 0
The trustee for The RTS Unit Trust trading as Respiratory Testing Services - O'Connor
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4740 - North Mackay
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3081 - Bellfield
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3076 - Epping
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3084 - Heidelberg
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3011 - Melbourne
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3050 - Parkville
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3084 - Rosanna
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6150 - Murdoch
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6163 - O'Connor
Recruitment outside Australia
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United States of America
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Norwich

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
[email protected]
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/NCT04173273