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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04607837
Recruitment Status : Active, not recruiting
First Posted : October 29, 2020
Last Update Posted : April 4, 2024
Sponsor:
Collaborator:
Arena is a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Description
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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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 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 12, 2021
Estimated Primary Completion Date : July 18, 2024
Estimated Study Completion Date : July 18, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants Achieving Clinical Remission [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Proportion of Participants Achieving Clinical Remission [ Time Frame: Week 12 ]
  2. Proportion of Participants Achieving Endoscopic Improvement [ Time Frame: Week 52 ]
  3. Proportion of Participants Achieving Symptomatic Remission [ Time Frame: Week 52 ]
  4. Proportion of Participants Achieving Mucosal Healing [ Time Frame: Week 52 ]
  5. Proportion of participants achieving clinical remission at both Weeks 12 and 52 [ Time Frame: Week 12 and Week 52 ]
  6. Proportion of Participants achieving clinical remission at Week 52 and who had not been receiving corticosteroids for ≥ 12 weeks immediately prior to Week 52 [ Time Frame: Week 52 ]
  7. 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.


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:

  • 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 ≥ 2 and rectal bleeding 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
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): NCT04607837


Locations
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Sponsors and Collaborators
Pfizer
Arena is a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04607837    
Other Study ID Numbers: APD334-210
C5041011 ( Other Identifier: Alias Study Number )
2020-003507-34 ( EudraCT Number )
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: April 4, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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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 Pfizer:
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