A Study Evaluating the Efficacy and Safety of Etrasimod in the Treatment of Patients With Moderately to Severely Active Crohn's Disease (CULTIVATE)
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|ClinicalTrials.gov Identifier: NCT04173273|
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Etrasimod Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease|
|Actual Study Start Date :||February 12, 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
|Experimental: Dose A||
Dose A taken by mouth, once daily.
Other Name: APD334
|Experimental: Dose B||
Dose B taken by mouth, once daily.
Other Name: APD334
|Placebo Comparator: Placebo||
Etrasimod matching placebo tablet taken by mouth, once daily.
- Proportion of Participants Who Achieve Endoscopic Response [ Time Frame: Week 14 ]Endoscopic response is defined as ≥ 50% decrease from baseline in simple endoscopic score in Crohn's disease (SES-CD)
- Proportion of Participants Who Achieve Clinical Remission Worst Daily Abdominal Pain With Loose/Watery Stool Frequency Scores (APSF) [ Time Frame: Week 14 ]Clinical remission APSF is defined as unweighted average worst daily abdominal pain (AP) score ≤ 1 (using a 4-point scale; ie, 0 [none] to 3 [severe]) and unweighted average daily loose/watery (Bristol Stool Form Scale [BSFS] type 6 or 7) SF score ≤ 3.
- Number and Severity of Adverse Events [ Time Frame: Up to Week 66 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173273
|Contact: Arena CT.gov Administrator||+1 firstname.lastname@example.org|
|Study Director:||Arena CT.gov Administrator||Arena Pharmaceuticals|