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Ulcerative ColitisPhase 3NCT04706793

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 study testing Etrasimod in people with Ulcerative Colitis, run by Pfizer at 38 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Etrasimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
38 sitesJapan
Study dates
25 Dec 2020to 3 Aug 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Japan38 sites

  • Asahikawa City Hospital

    Asahikawa-shi, Hokkaido, 070-8610

  • St. Luke's International Hospital

    Chuo-ku, Tokyo, 104-8560

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • NHO Mito Medical Center

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • JA- Kagoshima Koseiren Hospital (PET/DLCO)

    Kagoshima, Kagoshima-ken, 890-0062

  • Kagoshima Kouseiren Hospital

    Kagoshima, Kagoshima-ken, 890-0062

  • Clinical Pathology Laboratory (Diagnostick center)

    Kagoshima, Kagoshima-ken, 892-0813

  • Jiaikai Idzuro Imamura Hospital

    Kagoshima, Kagoshima-ken, 892-0824

  • Sameshima Eye Clinic (OCT)

    Kagoshima, Kagoshima-ken, 892-0825

  • Sameshima Hospital

    Kagoshima, Kagoshima-ken, 892-0846

  • NHO Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba, 277-0871

  • Takimoto Eye Clinic(OCT)

    Kasuga-shi, Fukuoka, 816-0863

  • Fakuoka Tokushukai Hospital

    Kasuga-shi, Fukuoka, 816-0864

  • Showa General Hospital

    Kodaira-shi, Tokyo, 187-8510

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520

  • National Hospital Organization Kyoto Medical Center

    Kyoto, Kyoto, 612-8555

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Ishii Eye Clinic

    Nagareyama-shi, Chiba, 270-0116

  • Kojunkai Daido Clinic

    Nagoya, Aichi-ken, 457-8511

  • Kojunkai Daido Hospital

    Nagoya, Aichi-ken, 457-8511

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Japan Community Health care Organization Osaka Hospital

    Osaka, Osaka, 553-0003

  • SUBARU Health Insurance Society Ota Memorial Hospital

    Ota-shi, Gunma, 373-8585

  • Saga University Hospital

    Saga, Saga-ken, 849-8501

  • JOHAS Tohoku Rokai Hospital

    Sendai, Miyagi, 981-8563

  • JOHAS Tohoku Rosai Hospital

    Sendai, Miyagi, 981-8563

  • Sendai City Hospital

    Sendai, Miyagi, 982-8502

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo, 169-0073

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

  • Matsumoto Eye Clinic

    Toride-shi, Ibaraki, 302-0014

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

  • Mie Prefectural General Medical Center

    Yokkaichi-shi, Mie-ken, 510-8561

Other trials in Japan

About this study

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

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).

Being tested
Etrasimod, Placebo
Keywords
Ulcerative Colitis, Etrasimod, APD334, UC
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrasimodDrug

    Also called APD334

    Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks

  • PlaceboDrug

    Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks

Study groups in NCT04706793
Study groupRoleWhat they receive
Etrasimod 2 mgExperimentalNot described
Receives: Drug: Etrasimod
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 40 of APD334-308

Secondary outcomes (5)

  1. 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.

    Measured: Week 40 of APD334-308

  2. 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.

    Measured: Week 40 of APD334-308

  3. 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.

    Measured: Week 40 of APD334-308

  4. 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.

    Measured: Week 40 of APD334-308

  5. 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.

    Measured: Week 40 of APD334-308

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start25 Dec 2020
  3. Primary completion3 Aug 2022
  4. Study completion3 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706793
Sponsor's protocol ID
APD334-308
Other IDs
C5041013
Status last verified
Sep 2023
First submitted
11 Jan 2021
Last updated
16 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Danese S, Goetsch M, Peyrin-Biroulet L, Yarur AJ, Dubinsky M, Rubin DT, Feagan BG, D'Haens G, Baert F, Lazin K, Gu G, Yu J, Lawendy N, Zang C, Wang W, Menon S, Law EH, Modesto I, Wosik K, Sidhu S, Niezychowski W, Vermeire S. The Efficacy and Safety of Etrasimod in Mildly to Moderately Active Ulcerative Colitis: Results From the Phase II GLADIATOR Trial. Clin Gastroenterol Hepatol. 2026 Jun 4:S1542-3565(26)00405-2. doi: 10.1016/j.cgh.2026.05.024. Online ahead of print.

    PubMed 42248437

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etrasimod in people with Ulcerative Colitis, run by Pfizer at 38 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308 (time frame: Week 40 of APD334-308). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04706793, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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