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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
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.
Trial website
https://clinicaltrials.gov/study/NCT05033340
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05033340