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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05033340




Registration number
NCT05033340
Ethics application status
Date submitted
20/11/2019
Date registered
21/11/2019
Date last updated
16/08/2024

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

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

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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

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)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

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

No information has been provided regarding IPD availability


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/NCT05033340