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Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Etrasimod
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Etrasimod, APD334, UC

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants with moderately to severely active ulcerative colitis (UC) are eligible to enroll into this study if they fulfill all of the following:

  • Must have completed the Week 12 visit of Study APD334-302
  • Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a participant < 20 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of participants < 20 years should be conducted only if acceptable according to local laws and regulations.
  • Both men and women subjects agree to use a highly effective method of birth control if the possibility of conception exists

Exclusion Criteria:

Participants who meet any of the following exclusion criteria will not be eligible for enrollment into the study:

  • If the Investigator considers the participant to be unsuitable for any reason to participate in the study
  • Participants requiring partial or total colectomy during the APD334-302 study
  • Participants requiring treatment with prohibited concomitant medications

Sites / Locations

  • Kojunkai Daido Clinic
  • Kojunkai Daido Hospital
  • Nagoya City University Hospital
  • Toyohashi Municipal Hospital
  • Tsujinaka Hospital Kashiwanoha
  • Ishii Eye Clinic
  • Fukuoka University Hospital
  • Takimoto Eye Clinic(OCT)
  • Fakuoka Tokushukai Hospital
  • Gifu University Hospital
  • SUBARU Health Insurance Society Ota Memorial Hospital
  • Hiroshima University Hospital
  • Asahikawa City Hospital
  • NHO Mito Medical Center
  • Matsumoto Eye Clinic
  • NHO Kanazawa Medical Center
  • Takamatsu Red Cross Hospital
  • Kagawa Prefectural Central Hospital
  • JA- Kagoshima Koseiren Hospital (PET/DLCO)
  • Kagoshima Kouseiren Hospital
  • Clinical Pathology Laboratory (Diagnostick center)
  • Jiaikai Idzuro Imamura Hospital
  • Sameshima Eye Clinic (OCT)
  • Sameshima Hospital
  • Japanese Red Cross Kumamoto Hospital
  • National Hospital Organization Kyoto Medical Center
  • Mie University Hospital
  • Mie Prefectural General Medical Center
  • JOHAS Tohoku Rokai Hospital
  • JOHAS Tohoku Rosai Hospital
  • Sendai City Hospital
  • Japan Community Health care Organization Osaka Hospital
  • Saga University Hospital
  • St. Luke's International Hospital
  • Showa General Hospital
  • Kitasato University Kitasato Institute Hospital
  • JCHO Tokyo Yamate Medical Center
  • Wakayama Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Etrasimod 2 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score 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

Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308
Endoscopic improvement was defined as an ES <=1 (excluding friability) at Week 40 of APD334-308 compared with Week 12 of APD334-302. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.
Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308
Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was 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 indicated more severe disease.
Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Percentage of Participants Achieving Sustained Clinical Remission
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. A subject with sustained clinical remission is defined as someone who achieved clinical remission at both Week 12 of APD334-302 and Week 40 of APD334-308.

Full Information

First Posted
January 11, 2021
Last Updated
September 22, 2023
Sponsor
Pfizer
Collaborators
Arena is a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04706793
Brief Title
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
Official Title
A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 25, 2020 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Arena is a wholly owned subsidiary of Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will continue with the same blinded treatment assigned in Study APD334-302 for a total treatment duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Etrasimod, APD334, UC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etrasimod 2 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Etrasimod
Other Intervention Name(s)
APD334
Intervention Description
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308
Description
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time Frame
Week 40 of APD334-308
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308
Description
Endoscopic improvement was defined as an ES <=1 (excluding friability) at Week 40 of APD334-308 compared with Week 12 of APD334-302. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.
Time Frame
Week 40 of APD334-308
Title
Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308
Description
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Time Frame
Week 40 of APD334-308
Title
Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308
Description
Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was 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 indicated more severe disease.
Time Frame
Week 40 of APD334-308
Title
Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry
Description
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time Frame
Week 40 of APD334-308
Title
Percentage of Participants Achieving Sustained Clinical Remission
Description
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. A subject with sustained clinical remission is defined as someone who achieved clinical remission at both Week 12 of APD334-302 and Week 40 of APD334-308.
Time Frame
Week 40 of APD334-308

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with moderately to severely active ulcerative colitis (UC) are eligible to enroll into this study if they fulfill all of the following: Must have completed the Week 12 visit of Study APD334-302 Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a participant < 20 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of participants < 20 years should be conducted only if acceptable according to local laws and regulations. Both men and women subjects agree to use a highly effective method of birth control if the possibility of conception exists Exclusion Criteria: Participants who meet any of the following exclusion criteria will not be eligible for enrollment into the study: If the Investigator considers the participant to be unsuitable for any reason to participate in the study Participants requiring partial or total colectomy during the APD334-302 study Participants requiring treatment with prohibited concomitant medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Kojunkai Daido Clinic
City
Nagoya-shi
State/Province
Aichi-ken
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Kojunkai Daido Hospital
City
Nagoya-shi
State/Province
Aichi-ken
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi-shi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Tsujinaka Hospital Kashiwanoha
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Facility Name
Ishii Eye Clinic
City
Nagareyama-shi
State/Province
Chiba
ZIP/Postal Code
270-0116
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Takimoto Eye Clinic(OCT)
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0863
Country
Japan
Facility Name
Fakuoka Tokushukai Hospital
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0864
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu-shi
State/Province
Gifu-ken
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
SUBARU Health Insurance Society Ota Memorial Hospital
City
Ota-shi
State/Province
Gunma
ZIP/Postal Code
373-8585
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Asahikawa City Hospital
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8610
Country
Japan
Facility Name
NHO Mito Medical Center
City
Higashiibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Matsumoto Eye Clinic
City
Toride-shi
State/Province
Ibaraki
ZIP/Postal Code
302-0014
Country
Japan
Facility Name
NHO Kanazawa Medical Center
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Takamatsu Red Cross Hospital
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
JA- Kagoshima Koseiren Hospital (PET/DLCO)
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0062
Country
Japan
Facility Name
Kagoshima Kouseiren Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0062
Country
Japan
Facility Name
Clinical Pathology Laboratory (Diagnostick center)
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0813
Country
Japan
Facility Name
Jiaikai Idzuro Imamura Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Sameshima Eye Clinic (OCT)
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0825
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
National Hospital Organization Kyoto Medical Center
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Mie University Hospital
City
Tsu-shi
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Mie Prefectural General Medical Center
City
Yokkaichi-shi
State/Province
MIE
ZIP/Postal Code
510-8561
Country
Japan
Facility Name
JOHAS Tohoku Rokai Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
JOHAS Tohoku Rosai Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
Sendai City Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
982-8502
Country
Japan
Facility Name
Japan Community Health care Organization Osaka Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Saga University Hospital
City
Saga-shi
State/Province
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
St. Luke's International Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Showa General Hospital
City
Kodaira-shi
State/Province
Tokyo
ZIP/Postal Code
187-8510
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
JCHO Tokyo Yamate Medical Center
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=APD334-308
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)

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