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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 : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Etrasimod Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose A Drug: Etrasimod
Dose A taken by mouth, once daily.
Other Name: APD334
Experimental: Dose B Drug: Etrasimod
Dose B taken by mouth, once daily.
Other Name: APD334
Placebo Comparator: Placebo Drug: Placebo
Etrasimod matching placebo tablet taken by mouth, once daily.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. Number and Severity of Adverse Events [ Time Frame: Up to Week 66 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com

Locations
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Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
More Information
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04173273    
Other Study ID Numbers: APD334-202
2019-002895-14 ( EudraCT Number )
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arena Pharmaceuticals:
Etrasimod
Crohn's disease
APD334
Inflammatory bowel disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases