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Trial record 1 of 1 for:    APD334-202
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A Study Evaluating the Efficacy and Safety of Etrasimod in the Treatment of Patients With Moderately to Severely Active Crohn's Disease (CULTIVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173273
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 20, 2019
First Posted Date  ICMJE November 21, 2019
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE February 12, 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Efficacy and Safety of Etrasimod in the Treatment of Patients With Moderately to Severely Active Crohn's Disease
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the dose-response relationship of two doses of etrasimod versus placebo as induction therapy in participants with moderately to severely active Crohn's disease and to select an oral etrasimod dose, based on efficacy and safety, for continued development.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Etrasimod
    Dose A taken by mouth, once daily.
    Other Name: APD334
  • Drug: Etrasimod
    Dose B taken by mouth, once daily.
    Other Name: APD334
  • Drug: Placebo
    Etrasimod matching placebo tablet taken by mouth, once daily.
Study Arms  ICMJE
  • Experimental: Dose A
    Intervention: Drug: Etrasimod
  • Experimental: Dose B
    Intervention: Drug: Etrasimod
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2019)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, 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 (TNFα) 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

Exclusion Criteria:

  • History of inadequate response (ie, primary non response) to agents from ≥ 2 classes of biologics marketed for the treatment of CD (ie, TNFα 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 Clostridium 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04173273
Other Study ID Numbers  ICMJE APD334-202
2019-002895-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arena Pharmaceuticals
Study Sponsor  ICMJE Arena Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
PRS Account Arena Pharmaceuticals
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP