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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 : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 23, 2020
First Posted Date  ICMJE October 29, 2020
Last Update Posted Date January 5, 2022
Actual Study Start Date  ICMJE April 19, 2021
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
Proportion of Participants Achieving Clinical Remission as Assessed by Total Mayo Clinic Score [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • 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 ]
  • Proportion of Participants Achieving Endoscopic Improvement [ Time Frame: Week 12 ]
  • Proportion of Participants With Histologic Response as Assessed by Robarts Histopathology Index Score [ Time Frame: Week 12 ]
  • Proportion of Participants With a Clinical Response as Assessed by Total Mayo Clinic Score [ Time Frame: Week 12 ]
  • Proportion of Participants Achieving Symptomatic Remission [ Time Frame: Week 12 ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
  • 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 ]
  • Proportion of Participants With Endoscopic Improvement [ Time Frame: Week 12 ]
  • Proportion of Participants With Histologic Response as Assessed by Robarts Histopathology Index Score [ Time Frame: Week 12 ]
  • Proportion of Participants With a Clinical Response as Assessed by Total Mayo Clinic Score [ Time Frame: Week 12 ]
  • Proportion of Participants With Symptomatic Remission [ Time Frame: Week 12 ]
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: Etrasimod
    Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
    Other Name: APD334
  • Drug: Placebo
    Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Study Arms  ICMJE
  • Experimental: Etrasimod 2 mg
    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: October 23, 2020)
162
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Australia,   Belarus,   Belgium,   Bulgaria,   Canada,   Czechia,   France,   Georgia,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Poland,   Portugal,   Russian Federation,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04607837
Other Study ID Numbers  ICMJE APD334-210
2020-003507-34 ( 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 December 2021

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