Evidence map›Paper›PMID 41297955›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2026

Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial.

Tadashi Terui, Yukari Okubo, Satomi Kobayashi, Akimichi Morita, Shinichi Imafuku, Yayoi Tada, Masatoshi Abe, Bruce Strober, Melinda Gooderham, Wendy Zhang and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05174065 (A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Apremilast), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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.

NCT05174065 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Apremilast (AMG 407) in Japanese Subjects With Palmoplantar Pustulosis (PPP)

TypeinterventionalSponsorAmgenRan2022 to 2024Enrolled176ConditionsPalmoplantar PustulosisArmsApremilast, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
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

16 authors.

Tadashi TeruiNihon University School of Medicine, Tokyo, Japan.
Yukari OkuboTokyo Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-9526-1259
Satomi KobayashiSeibo International Catholic Hospital, Tokyo, Japan.
Akimichi MoritaNagoya City University, Nagoya City, Japan.ORCID https://orcid.org/0000-0001-8372-3754
Shinichi ImafukuFukuoka University, Fukuoka, Japan.
Yayoi TadaTeikyo University, Tokyo, Japan.
Masatoshi AbeSapporo Skin Clinic, Sapporo, Japan.
Bruce StroberYale University, New Haven, Connecticut, USA.ORCID https://orcid.org/0000-0002-8394-2057
Melinda GooderhamSKiN Centre for Dermatology, Peterborough, Ontario, Canada.
Wendy ZhangAmgen Inc., Thousand Oaks, California, USA.
Junichiro ShimauchiAmgen K.K, Tokyo, Japan.
Masafumi YaguchiAmgen K.K, Tokyo, Japan.
Takeshi KimuraAmgen K.K, Tokyo, Japan.
Ryuichi OgawaAmgen K.K, Tokyo, Japan.
Hamid AmouzadehAmgen Inc., Thousand Oaks, California, USA.
Masamoto MurakamiMiyazaki University, Miyazaki, Japan.

Funding

Amgen Inc.
6 · The paper itself

Abstract

backgroundPalmoplantar pustulosis (PPP) is a difficult-to-treat chronic dermatitis with limited treatment options.

objectivesTo report results from a Phase 3 study of apremilast in patients with moderate to severe PPP (NCT05174065).

methodsIn this randomized, placebo-controlled, double-blind, confirmatory study, Japanese adults with PPP Area and Severity Index (PPPASI) total score ≥12, PPPASI pustules/vesicles severity score ≥2 and inadequate response to topicals were randomly assigned (1:1) to apremilast or placebo for 16 weeks, followed by an active treatment phase where all patients received apremilast through Week 52. The primary endpoint was a ≥50% reduction in PPPASI total score (PPPASI-50) at Week 16, evaluated in all randomized patients. Safety outcomes were assessed in all patients who received ≥1 dose of the study drug.

resultsBetween March 8, 2022 to April 28, 2023, 176 patients (141 [80%] women, 35 [20%] men) were randomly assigned to apremilast (n = 88 [50%]) or placebo (n = 88 [50%]). Mean (SD) PPPASI total score at baseline was 22.1 (8.1) in the apremilast group and 22.0 (8.4) in the placebo group. A significantly greater proportion of patients achieved PPPASI-50 at Week 16 with apremilast versus placebo (60 of 88 [68%] vs. 31 of 88 [35%]; treatment difference: 32.6% [95% CI: 18.7, 46.5], p < 0.0001). Improvements were maintained through Week 52. The most common adverse events (≥10% of patients) during the double-blind phase in patients receiving apremilast were diarrhea (placebo: n = 3 [3%]; apremilast: n = 17 [19%]), feces soft (placebo: n = 1 [1%]; apremilast: n = 15 [17%]), headache (placebo: n = 2 [2%]; apremilast: n = 10 [11%]) and nausea (placebo: n = 1 [1%]; apremilast: n = 10 [11%]). There were no events of depression or fatal adverse events.

conclusionsIn this Phase 3 trial, apremilast was effective in Japanese patients with moderate to severe PPP. Adverse events were consistent with the known safety profile of apremilast. CLINICALTRIALS: gov: NCT05174065.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalPsoriasisThalidomideAdultAgedDouble-Blind MethodEast Asian PeopleFemaleHumansJapanMaleMiddle AgedSeverity of Illness IndexAnti-Inflammatory Agents, Non-SteroidalapremilastThalidomideclinical trialPhase 3phosphodiesterase 4 inhibitorpustulosis palmaris et plantaris

Identifiers

PMID41297955
PMCPMC13206257

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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.