Evidence map›Paper›PMID 40275818›Full record

ArticleIntestinal research2026

Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study.

Ken Takeuchi, Hiroshi Nakase, Tadakazu Hisamatsu, Katsuyoshi Matsuoka, Shoko Arai, Hirotoshi Yuasa, Motoki Oe, Ryosuke Ono, Michael Keating, Guibao Gu and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Intestinal research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05061446 (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), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05061446 phase2completednot on this map

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

TypeinterventionalSponsorPfizerRan2021 to 2023Enrolled54ConditionsUlcerative ColitisArmsEtrasimod, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ken TakeuchiDepartment of Gastroenterology, IBD Center, Tsujinaka Hospital Kashiwanoha, Kashiwa, Japan.
Hiroshi NakaseDepartment of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Tadakazu HisamatsuDepartment of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan.
Katsuyoshi MatsuokaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.
Shoko AraiPfizer Japan Inc., Tokyo, Japan.
Hirotoshi YuasaPfizer R&D Japan, Tokyo, Japan.
Motoki OePfizer R&D Japan, Tokyo, Japan.
Ryosuke OnoPfizer R&D Japan, Tokyo, Japan.
Michael KeatingPfizer Inc, New York, NY, USA.
Guibao GuPfizer Inc, La Jolla, CA, USA.
Krisztina LazinPfizer AG, Zürich, Switzerland.
Aoibhinn McDonnellPfizer Ltd, Sandwich, UK.
Koki FukutaPfizer Japan Inc., Tokyo, Japan.
Toshifumi HibiCenter for Advanced Inflammatory Bowel Disease Research and Treatment, Kitasato University, Kitasato Institute Hospital, Tokyo, Japan.

Funding

Pfizer
6 · The paper itself

Abstract

BACKGROUND/

aimsEtrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). However, its efficacy, safety, and the appropriate dosage have not been extensively investigated in the Japanese population.

methodsThis phase 2, multicenter, randomized, double-blind, placebo-controlled dose-ranging, 12-week trial was carried out among Japanese patients with moderately to severely active UC. Patients were randomized 1:1:1 to receive etrasimod 1 mg once daily (QD), etrasimod 2 mg QD, or placebo. The primary efficacy endpoint was the proportion of patients achieving clinical remission at week 12. Secondary efficacy endpoints and treatmentemergent adverse events (TEAEs) were also investigated. Efficacy endpoints were presented as proportions of patients achieving each outcome.

resultsOverall, 17, 19, and 18 patients received etrasimod 1 mg QD, etrasimod 2 mg QD, and placebo, respectively. One patient receiving etrasimod 1 mg (6.7%), 5 patients receiving etrasimod 2 mg (26.3%), and no patients receiving placebo (0%) achieved clinical remission. More patients receiving etrasimod versus placebo achieved secondary endpoints, except endoscopic normalization, at week 12. TEAEs were experienced by 9 patients receiving etrasimod 1 mg (52.9%), 13 patients receiving etrasimod 2 mg (68.4%), and 10 patients receiving placebo (55.6%). None of the TEAEs were serious and none experienced by patients receiving etrasimod led to treatment discontinuation.

conclusionsOverall, etrasimod 2 mg QD for up to 12 weeks appeared efficacious and safe in these Japanese patients with moderately to severely active UC. All TEAEs were mild to moderate in severity. (ClinicalTrials.gov: NCT05061446).

Indexed as

EtrasimodS1P receptor modulatorUlcerative colitis

Identifiers

PMID40275818
PMCPMC13153859

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.