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

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

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).

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Etrasimod; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
    • Toyohashi-shi, Aichi, Japan, 441-8570
      • Toyohashi Municipal Hospital
  • Aichi-ken
    • Nagoya-shi, Aichi-ken, Japan, 457-8511
      • Kojunkai Daido Clinic
    • Nagoya-shi, Aichi-ken, Japan, 457-8511
      • Kojunkai Daido Hospital
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Tsujinaka Hospital Kashiwanoha
    • Nagareyama-shi, Chiba, Japan, 270-0116
      • Ishii Eye Clinic
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital
    • Kasuga-shi, Fukuoka, Japan, 816-0863
      • Takimoto Eye Clinic(OCT)
    • Kasuga-shi, Fukuoka, Japan, 816-0864
      • Fakuoka Tokushukai Hospital
  • Gifu-ken
    • Gifu-shi, Gifu-ken, Japan, 501-1194
      • Gifu University Hospital
  • Gunma
    • Ota-shi, Gunma, Japan, 373-8585
      • SUBARU Health Insurance Society Ota Memorial Hospital
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 734-8551
      • Hiroshima University Hospital
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8610
      • Asahikawa City Hospital
  • Ibaraki
    • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
      • NHO Mito Medical Center
    • Toride-shi, Ibaraki, Japan, 302-0014
      • Matsumoto Eye Clinic
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8650
      • NHO Kanazawa Medical Center
  • Kagawa
    • Takamatsu-shi, Kagawa, Japan, 760-0017
      • Takamatsu Red Cross Hospital
    • Takamatsu-shi, Kagawa, Japan, 760-8557
      • Kagawa Prefectural Central Hospital
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 892-0846
      • Sameshima Hospital
    • Kagoshima-shi, Kagoshima, Japan, 890-0062
      • JA- Kagoshima Koseiren Hospital (PET/DLCO)
    • Kagoshima-shi, Kagoshima, Japan, 892-0813
      • Clinical Pathology Laboratory (Diagnostick center)
    • Kagoshima-shi, Kagoshima, Japan, 892-0825
      • Sameshima Eye Clinic (OCT)
    • Kagoshima-shi, Kagoshima, Japan, 890-0062
      • Kagoshima Kouseiren Hospital
    • Kagoshima-shi, Kagoshima, Japan, 892-0824
      • Jiaikai Idzuro Imamura Hospital
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan, 861-8520
      • Japanese Red Cross Kumamoto Hospital
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 612-8555
      • National Hospital Organization Kyoto Medical Center
  • MIE
    • Tsu-shi, MIE, Japan, 514-8507
      • Mie University Hospital
    • Yokkaichi-shi, MIE, Japan, 510-8561
      • Mie Prefectural General Medical Center
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 981-8563
      • JOHAS Tohoku Rosai Hospital
    • Sendai-shi, Miyagi, Japan, 982-8502
      • Sendai City Hospital
    • Sendai-shi, Miyagi, Japan, 981-8563
      • JOHAS Tohoku Rokai Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan, 553-0003
      • Japan Community Health care Organization Osaka Hospital
  • Saga
    • Saga-shi, Saga, Japan, 849-8501
      • Saga University Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St. Luke's International Hospital
    • Kodaira-shi, Tokyo, Japan, 187-8510
      • Showa General Hospital
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Shinjuku-ku, Tokyo, Japan, 169-0073
      • JCHO Tokyo Yamate Medical Center
  • Wakayama
    • Wakayama-shi, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks
Experimental: Etrasimod 2 mg	Drug: Etrasimod; Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks; Other Names: APD334

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 40 of APD334-308

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 40 of APD334-308
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.	Week 40 of APD334-308
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.	Week 40 of APD334-308
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.	Week 40 of APD334-308
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.	Week 40 of APD334-308

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Arena is a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2020
• Primary Completion (Actual): August 3, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Etrasimod; APD334; UC
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: APD334-308; C5041013 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• 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