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Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02447302
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief Summary:
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : October 15, 2015
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Etrasimod Low Dose
Oral, low dose, daily for 12 Weeks
Drug: Etrasimod
Other Name: APD334

Experimental: Etrasimod High Dose
Oral, high dose, daily for 12 weeks
Drug: Etrasimod
Other Name: APD334

Placebo Comparator: Placebo
Oral, placebo, daily for 12 weeks.
Drug: Placebo



Primary Outcome Measures :
  1. Change From Baseline in Adapted Mayo Score (MCS) at Week 12 [ Time Frame: Baseline and Week 12 ]
    The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 [ Time Frame: Week 12 ]
    For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.

  2. Change From Baseline in 2-component MCS at Week 12 [ Time Frame: Baseline and Week 12 ]
    The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.

  3. Change From Baseline in Total Mayo Score (TMS) at Week 12 [ Time Frame: Baseline and Week 12 ]
    The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores [stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.


Other Outcome Measures:
  1. Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12 [ Time Frame: Week 12 ]
    The trichotomous composite score of clinical remission and clinical response at Week 12 is an ordinal categorical endpoint with 3 categories (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response, and 0 for achieving neither). Multiple imputation method was used to handle missing data.

  2. Percentage of Participants Who Achieved Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    A participant was considered to have achieved clinical remission if he/she had: 1) an endoscopy score using flexible proctosigmoidoscopy of 0 or 1 (excluding friability), 2) a rectal bleeding score of 0 or 1, and 3) a stool frequency score of 0 or 1 with a decrease of ≥1 point from baseline. Multiple imputation method was used to handle missing data.

  3. Percentage of Participants Who Achieved Clinical Response at Week 12 [ Time Frame: Week 12 ]
    A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission defined above, or met criteria of clinical response. Clinical response was defined as a decrease in the adapted MCS of ≥ 2 points and a decrease of ≥ 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1.



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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:

  • Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
  • Evidence of colonic ulcerative colitis activity on endoscopy

Exclusion Criteria:

  • Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
  • Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
  • Any prior exposure to natalizumab, efalizumab, or rituximab

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): NCT02447302


Locations
Show Show 134 study locations
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Arena Pharmaceuticals:
Study Protocol  [PDF] April 3, 2017
Statistical Analysis Plan  [PDF] February 27, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02447302    
Other Study ID Numbers: APD334-003
2015-001942-28 ( EudraCT Number )
First Posted: May 18, 2015    Key Record Dates
Results First Posted: April 5, 2021
Last Update Posted: April 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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