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Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis (GLADIATOR UC)

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ClinicalTrials.gov Identifier: NCT04607837
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief Summary:
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Etrasimod Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Etrasimod 2 mg Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Other Name: APD334

Placebo Comparator: Placebo Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment




Primary Outcome Measures :
  1. Proportion of Participants Achieving Clinical Remission as Assessed by Total Mayo Clinic Score [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Proportion of Participants With Reduction From Baseline in Both Endoscopic Score and Rectal Bleeding or in Both Endoscopic Score and Stool Frequency [ Time Frame: Week 12 ]
  2. Proportion of Participants With Endoscopic Improvement [ Time Frame: Week 12 ]
  3. Proportion of Participants With Histologic Response as Assessed by Robarts Histopathology Index Score [ Time Frame: Week 12 ]
  4. Proportion of Participants With a Clinical Response as Assessed by Total Mayo Clinic Score [ Time Frame: Week 12 ]
  5. Proportion of Participants With Symptomatic Remission [ Time Frame: Week 12 ]
  6. Number and Severity of Adverse Events [ Time Frame: Up to approximately 56 weeks (52-Week Treatment Period and 4-Week Follow-Up Period) ]
    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.



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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:

  • Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
  • Active UC confirmed by endoscopy
  • Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 1
  • Received a surveillance colonoscopy within 12 months before baseline

Exclusion Criteria:

  • Severe extensive colitis
  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
  • Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening

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): NCT04607837


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
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04607837    
Other Study ID Numbers: APD334-210
2020-003507-34 ( EudraCT Number )
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
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:
Ulcerative colitis
Etrasimod
APD334
UC
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases