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
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
-
Clinical Trial Information
Trial Contact: Garcia de Djuro, Ginette; Britton, David ; Shepherd, Adriane R
Trial Phone: 321.841.6649 ; 321.841.2684 ; 321 841-2285
-
IRB No: W.22.076.03
Protocol Abbrev: CULTIVATE
Principal Investigator: Udayakumar Navaneethan, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: APD334-202
Treatment: Oral etrasimod (APD334)
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04173273
-
Objective
Primary Objectives
Substudy A is complete.
Substudy 1 – Phase 2b
• To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction
therapy in subjects with moderately to severely active CD
• To select an oral etrasimod dose(s), based on efficacy and safety, for continued development
Substudy 2 – Induction (Phase 3)
• To evaluate the efficacy of the selected etrasimod dose versus placebo as induction therapy in
subjects with moderately to severely active CD
Substudy 3 – Maintenance (Phase 3)
• To evaluate the efficacy of etrasimod versus placebo as maintenance therapy in subjects with
moderately to severely active CD
Substudy 4 – Long-Term Extension
• To evaluate the long-term safety and tolerability of etrasimod in subjects with moderately to
severely active CD -
Key Eligibility
Have CD for ≥ 3 months prior to randomization, involving the ileum and/or colon, at a minimum; diagnosis may be confirmed at any time in the past by endoscopy and/or histopathology. The screening endoscopy and histopathology reports may serve as source documents for subjects who do not have diagnostic endoscopy reports in their medical chart.
Have moderately to severely active CD at Screening.
