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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706793
• Other study ID #: APD334-308
• Secondary ID: C5041013
• Status: Completed
• Phase: Phase 3
• Start date: December 25, 2020
• Est. completion date: August 3, 2022

Study information

• Verified date: September 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks
• Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks

Locations

Country	Name	City	State
Japan	Asahikawa City Hospital	Asahikawa-shi	Hokkaido
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Gifu University Hospital	Gifu-shi	Gifu-ken
Japan	NHO Mito Medical Center	Higashiibaraki-gun	Ibaraki
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima
Japan	Clinical Pathology Laboratory (Diagnostick center)	Kagoshima-shi	Kagoshima
Japan	JA- Kagoshima Koseiren Hospital (PET/DLCO)	Kagoshima-shi	Kagoshima
Japan	Jiaikai Idzuro Imamura Hospital	Kagoshima-shi	Kagoshima
Japan	Kagoshima Kouseiren Hospital	Kagoshima-shi	Kagoshima
Japan	Sameshima Eye Clinic (OCT)	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital	Kagoshima-shi	Kagoshima
Japan	NHO Kanazawa Medical Center	Kanazawa-shi	Ishikawa
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa-shi	Chiba
Japan	Fakuoka Tokushukai Hospital	Kasuga-shi	Fukuoka
Japan	Takimoto Eye Clinic(OCT)	Kasuga-shi	Fukuoka
Japan	Showa General Hospital	Kodaira-shi	Tokyo
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto-shi	Kumamoto
Japan	National Hospital Organization Kyoto Medical Center	Kyoto-shi	Kyoto
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo
Japan	Ishii Eye Clinic	Nagareyama-shi	Chiba
Japan	Kojunkai Daido Clinic	Nagoya-shi	Aichi-ken
Japan	Kojunkai Daido Hospital	Nagoya-shi	Aichi-ken
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	Japan Community Health care Organization Osaka Hospital	Osaka-shi	Osaka
Japan	SUBARU Health Insurance Society Ota Memorial Hospital	Ota-shi	Gunma
Japan	Saga University Hospital	Saga-shi	Saga
Japan	JOHAS Tohoku Rokai Hospital	Sendai-shi	Miyagi
Japan	JOHAS Tohoku Rosai Hospital	Sendai-shi	Miyagi
Japan	Sendai City Hospital	Sendai-shi	Miyagi
Japan	JCHO Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo
Japan	Kagawa Prefectural Central Hospital	Takamatsu-shi	Kagawa
Japan	Takamatsu Red Cross Hospital	Takamatsu-shi	Kagawa
Japan	Matsumoto Eye Clinic	Toride-shi	Ibaraki
Japan	Toyohashi Municipal Hospital	Toyohashi-shi	Aichi
Japan	Mie University Hospital	Tsu-shi	MIE
Japan	Wakayama Medical University Hospital	Wakayama-shi	Wakayama
Japan	Mie Prefectural General Medical Center	Yokkaichi-shi	MIE

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Arena is a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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