Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

Phase 3 Completed 176 enrolled Amgen

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to evaluate the efficacy of apremilast (AMG 407) twice daily (BID) compared with placebo in participants with Palmoplantar Pustulosis (PPP).

Timeline

Start: 2022-03-08
Primary completion: 2023-08-19
Completion: 2024-06-01

Outcome

Met primary endpoint

paper A significantly greater proportion of patients achieved PPPASI-50 at Week 16 with apremilast versus placebo PMID 41297955 ↗

paper (60 of 88 [68%] vs. 31 of 88 [35%]; treatment difference: 32.6% [95% CI: 18.7, 46.5], p < 0.0001). PMID 41297955 ↗

release “A Phase 3 study evaluating the efficacy and safety of Otezla in Japanese patients with palmoplantar pustulosis successfully met the primary and secondary endpoints.” amgen.com ↗

release “Late-Breaking Phase 3 Study of Otezla in Palmoplantar Pustulosis Achieves Primary and Secondary Endpoints at 16 Weeks” amgen.com ↗

Publications

Terui T, Okubo Y, Kobayashi S, Morita A, Imafuku S, Tada Y, Abe M, Strober B, Gooderham M, Zhang W, Shimauchi J, Yaguchi M, Kimura T, Ogawa R, Amouzadeh H, Murakami M. Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial. J Eur Acad Dermatol Venereol. 2026 Jun;40(6):994-1004. doi: 10.1111/jdv.70166. Epub 2025 Nov 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	—	Oral