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Ulcerative ColitisPhase 2NCT05061446

Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 2 study testing Etrasimod in people with Ulcerative Colitis, run by Pfizer at 80 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 Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks. Read more about this study

Who is it for?
Ages 18 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
54 participants
Where
80 sitesJapan
Study dates
10 Sep 2021to 6 Oct 2023
Phase
Phase 2
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Japanese ancestry
  • Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
  • Having active UC confirmed by endoscopy
  • Moderately to severely active UC

Who cannot join

  • Severe extensive colitis
  • Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Trial locations and contacts

80 sites in 1 country.

80 sites in 1 country

Japan80 sites

  • Asahikawa City Hospital

    Asahikawa-shi, Hokkaido, 070-8610

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku, Tokyo, 113-8519

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Nakayama EYE Clinic

    Fukuyama-shi, Hiroshima, 720-0822

  • NHO Fukuyama Medical Center

    Fukuyama-shi, Hiroshima, 720-8520

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Tokai University Hachioji Hospital

    Hachiōji, Tokyo, 192-0032

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Matsuda Hospital

    Hamamatsu, Shizuoka, 432-8061

  • Hamamatsu Medical Centre

    Hamamatsu, Shizuoka, 432-8580

  • NHO Mito Medical Center

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191

  • NHO Hirosaki General Medical Center

    Hirosaki-shi, Aomori, 036-8545

  • Hirosaki University Hospital(OCT/PFT/DLCO)

    Hirosaki-shi, Aomori, 036-8563

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori, 036-8563

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Saitama Medical University Hospital

    Iruma-gun, Saitama, 350-0495

  • JA- Kagoshima Koseiren Hospital (PET/DLCO)

    Kagoshima, Kagoshima-ken, 890-0062

  • Clinical Pathology Laboratory (Diagnostick center)

    Kagoshima, Kagoshima-ken, 892-0813

  • Sameshima Eye Clinic (OCT)

    Kagoshima, Kagoshima-ken, 892-0825

  • Sameshima Hospital

    Kagoshima, Kagoshima-ken, 892-0846

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • NHO Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba, 277-0871

  • Medical Corporation Tokushukai Kishiwada Tokushukai Hospital

    Kishiwada-shi, Osaka, 596-0042

  • Japan Community Health Care Organization Kyushu Hospital

    Kitakyushu, Fukuoka, 806-8501

  • Kokura Memorial Hospital

    Kitakyushu-shi, Fukuoka, 802-8555

  • Kitakyushu Municipal Medical Center

    Kitakyushu-shi, Fukuoka, 802-8561

  • Koyanose Eye Clinic

    Kitakyushu-shi, Fukuoka, 807-1266

  • Showa General Hospital

    Kodaira-shi, Tokyo, 187-8510

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

  • Yuai Memorial Hospital

    Koga-shi, Ibaraki, 306-0232

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520

  • Our Lady of the Snow St. Mary's Hospital

    Kurume, Fukuoka, 830-8543

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Kokura Memorial Hospital

    Kutakyushu-shi, Fukuoka, 802-8555

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • National Hospital Organization Kyoto Medical Center

    Kyoto, Kyoto, 612-8555

  • Saiseikai Matsuyama Hospital

    Matsuyama, Ehime, 791-8026

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Kudo Internist Heart Clinic

    Morioka, Iwate, 020-0871

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-8505

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, 480-1195

  • Nagaoka Red Cross Hospital

    Nagaoka-shi, Niigata, 940-2085

  • Ishii Eye Clinic

    Nagareyama-shi, Chiba, 270-0116

  • Kojunkai Daido Clinic

    Nagoya, Aichi-ken, 457-8511

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Kojunkai Daido Hospital

    Nagoya, Aixhi-ken, 457-8511

  • Fukuoka Shinmizumaki Hospital

    Onga-gun, Fukuoka, 807-0051

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586

  • Japan Community Health care Organization Osaka Hospital

    Osaka, Osaka, 553-0003

  • NHO Osaka National Hospital

    Osaka, 540-0006

  • Osaka National Hospital Institutional Review Board

    Osaka, 540-0006

  • SUBARU Health Insurance Society Ota Memorial Hospital

    Ota-shi, Gunma, 373-8585

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Saga University Hospital

    Saga, Saga-ken, 849-8501

  • Sagamihara Kyodo Hospital

    Sagamihara, Kanagawa, 252-5188

  • Japan Community Health care Organization Saitama Medical Center

    Saitama-shi, Saitama, 330-0074

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, Hokkaido, 004-0041

  • Sapporo-Kosei General Hospital

    Sapporo, Hokkaido, 060-0033

  • Ibaraki Seinan Medical Center Hospital

    Sashima-gun, Ibaraki, 306-0433

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • JOHAS Tohoku Rosai Hospital

    Sendai, Miyagi, 981-8563

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo, 169-0073

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka, 569-8686

  • Teikyo University Hospital

    Tokyo, 173-8606

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295

  • Matsumoto Eye Clinic

    Toride-shi, Ibaraki, 302-0014

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Tsuchiura Kyodo General Hospital

    Tsuchiura-shi, Ibaraki, 300-0028

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

  • Hinaga Nishi Ophthalmology Clinic

    Yokkaichi- Shi, Mie-ken, 510-0891

  • Mie Prefectural General Medical Center

    Yokkaichi-shi, Mie-ken, 510-8561

  • Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital

    Yokohama, Kanagawa, 234-0054

  • NHO Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.

Being tested
Etrasimod, Placebo
Keywords
Ulcerative Colitis, APD334, Etrasimod
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 tablet by mouth, once daily for 12 weeks

  • EtrasimodDrug

    Also called APD334

    Etrasimod tablet by mouth, once daily for 12 weeks

  • PlaceboDrug

    Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks

Study groups in NCT05061446
Study groupRoleWhat they receive
Etrasimod Dose 1ExperimentalNot described
Receives: Drug: Etrasimod
Etrasimod Dose 2ExperimentalNot 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 Who Achieved Clinical Remission at Week 12

    Clinical remission:Participants with stool frequency (SF)subscore=0(or of 1 with greater than or equal to(>=)1 point decrease from baseline,rectal bleeding(RB)subscore=0 and endoscopic score(ES)less than or equal to(<)=1(excluding friability).SF subscore:number of stools in 24-hours relative to normal number of stools for that participant in same period,score ranged from 0(normal number of stools) to 3(5 or more stools than normal),higher scores=more severity.RB subscore:most severe amount of blood passed per rectum in 24-hours,score ranged from 0(no blood seen)to 3(blood alone passes),higher scores=more severity.ES:reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,score ranged from 0(normal or inactive disease) to 3(severe disease [spontaneous bleeding,ulceration]),higher scores=more severity.Modified Mayo score:measure disease activity for UC,score:0(normal) to 9(maximum severity),comprised subscores for SF,RB,ES.higher score=more severe disease activity.

    Measured: Week 12

Secondary outcomes (5)

  1. Percentage of Participants Who Achieved Endoscopic Improvement at Week 12

    Endoscopic improvement was defined as ES <= 1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity),and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.

    Measured: Week 12

  2. Percentage of Participants Who Achieved Symptomatic Remission at Week 12

    Symptomatic remission was defined as SF sub score = 0 (or = 1 with a >= 1 point decrease from baseline) and RB sub score = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.

    Measured: Week 12

  3. Percentage of Participants Who Achieved Mucosal Healing at Week 12

    Mucosal healing was defined as ES <= 1 (excluding friability) with histologic remission defined as a Geboes index score < 2.0). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. 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. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), comprised subscores for SF, RB, ES. Higher score = more severe disease activity.

    Measured: Week 12

  4. Percentage of Participants Who Achieved Clinical Response at Week 12

    Clinical response was defined as a >= 2-point and >= 30 percentage (%) decrease from baseline in MMS, and a >= 1-point decrease from baseline in RB subscore or an absolute RB subscore <= 1. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity.

    Measured: Week 12

  5. Percentage of Participants Who Achieved Endoscopic Normalization at Week 12

    Endoscopic normalization was defined as ES= 0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.

    Measured: Week 12

Timeline

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

  1. First posted29 Sep 2021
  2. Study start10 Sep 2021
  3. Primary completion6 Oct 2023
  4. Study completion6 Oct 2023

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05061446
Sponsor's protocol ID
APD334-203
Other IDs
C5041007
Status last verified
Oct 2024
First submitted
20 Sep 2021
Last updated
29 Oct 2024
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

  • Takeuchi K, Nakase H, Hisamatsu T, Matsuoka K, Arai S, Yuasa H, Oe M, Ono R, Keating M, Gu G, Lazin K, McDonnell A, Fukuta K, Hibi T. Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study. Intest Res. 2026 Apr;24(2):352-365. doi: 10.5217/ir.2024.00213. Epub 2025 Apr 25.

    PubMed 40275818

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etrasimod in people with Ulcerative Colitis, run by Pfizer at 80 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 3 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 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Oct 2024). 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 Who Achieved Clinical Remission at Week 12 (time frame: Week 12). 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 NCT05061446, 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 29 Oct 2024.

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