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Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC 52)

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ClinicalTrials.gov Identifier: NCT03945188
Recruitment Status : Completed
First Posted : May 10, 2019
Results First Posted : December 20, 2022
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

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 to severely active ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Etrasimod Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : June 13, 2019
Actual Primary Completion Date : February 8, 2022
Actual Study Completion Date : February 16, 2022

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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. Percentage of Participants Achieving Clinical Remission at Week 12 [ Time Frame: At Week 12 ]
    Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

  2. Percentage of Participants Achieving Clinical Remission at Week 52 [ Time Frame: At Week 52 ]
    Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Endoscopic Improvement at Week 12 [ Time Frame: At Week 12 ]
    Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).

  2. Percentage of Participants Achieving Endoscopic Improvement at Week 52 [ Time Frame: At Week 52 ]
    Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).

  3. Percentage of Participants Achieving Symptomatic Remission at Week 12 [ Time Frame: At Week 12 ]
    Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.

  4. Percentage of Participants Achieving Symptomatic Remission at Week 52 [ Time Frame: At Week 52 ]
    Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.

  5. Percentage of Participants With Mucosal Healing at Week 12 [ Time Frame: At Week 12 ]
    Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.

  6. Percentage of Participants With Mucosal Healing at Week 52 [ Time Frame: At Week 52 ]
    Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.

  7. Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52 [ Time Frame: At Week 52 ]
    Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

  8. Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52 [ Time Frame: At Weeks 12 and 52 ]
    Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

  9. Percentage of Participants Achieving Clinical Response at Week 12 [ Time Frame: At Week 12 ]
    Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

  10. Percentage of Participants Achieving Clinical Response at Week 52 [ Time Frame: At Week 52 ]
    Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB sub-score ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

  11. Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52 [ Time Frame: At Weeks 12 and 52 ]
    Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

  12. Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52 [ Time Frame: At Weeks 12 and 52 ]
    Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.

  13. Percentage of Participants Achieving Endoscopic Normalization at Week 12 [ Time Frame: At Week 12 ]
    Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).

  14. Percentage of Participants Achieving Endoscopic Normalization at Week 52 [ Time Frame: At Week 52 ]
    Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).

  15. Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52 [ Time Frame: At Weeks 12 and 52 ]
    Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).

  16. Percentage of Participants Achieving Symptomatic Remission by Study Visit [ Time Frame: At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48 ]
    Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.

  17. Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit [ Time Frame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52 ]
    Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.

  18. Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit [ Time Frame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]
    Non-invasive clinical response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores, and a ≥ 1-point decrease from Baseline in RB subscore or RB subscore ≤ 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.

  19. Percentage of Participants Achieving Symptomatic Response by Study Visit [ Time Frame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]
    Symptomatic response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.

  20. Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline [ Time Frame: At Week 52 ]
    Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1, and have not received corticosteroids for ≥ 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

  21. Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12 [ Time Frame: At Week 52 ]
    Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
  2. Active UC confirmed by endoscopy

Exclusion criteria:

  1. Severe extensive colitis
  2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
  3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
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): NCT03945188


Locations
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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] December 22, 2020
Statistical Analysis Plan  [PDF] January 19, 2022

More Information
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Additional Information:

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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03945188    
Other Study ID Numbers: APD334-301
2018-003985-15 ( EudraCT Number )
First Posted: May 10, 2019    Key Record Dates
Results First Posted: December 20, 2022
Last Update Posted: December 20, 2022
Last Verified: March 2022
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
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