Xera Med Research | Boca Raton, FL
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About
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.
Full description
This study includes 5 substudies:
Substudy A - Phase 2: A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in participants with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3.
Substudy 1 - Phase 2: A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3.
Substudy 2 - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy.
Substudy 3 - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy. Participants from Substudy 1 and Substudy 2 will be enrolled in Substudy 3.
Substudy 4 - Long-Term Extension: A long-term extension substudy for participants who complete at least 52 weeks of treatment. Participants from Substudy 3 and Substudy A are planned to be enrolled in Substudy 4.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Eligibility criteria applicable to all substudies:
Inclusion Criteria:
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:
Females of childbearing potential must be nonpregnant
Females of childbearing potential and males must use contraception
Exclusion Criteria:
Inclusion Criteria for Substudy 3:
Inclusion Criteria for Substudy 4:
Primary purpose
Allocation
Interventional model
Masking
1,175 participants in 3 patient groups, including a placebo group
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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