NCT04451720

Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis

Completed Phase 3 Last updated 5 December 2022

What this trial tests

Phase 3 trial testing Risankizumab in Palmoplantar Pustulosis (PPP) in 119 participants. Completed in 21 November 2022.

Timeline

20 July 2020

Primary endpoint
21 November 2022

21 November 2022

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	119
Start date	20 July 2020
Primary completion	21 November 2022
Estimated completion	21 November 2022
Sites	39 locations across Japan

Drugs / interventions tested

• Risankizumab (RISANKIZUMAB) — full drug profile →
• Placebo

Conditions studied

• Palmoplantar Pustulosis (PPP) — all drugs for Palmoplantar Pustulosis (PPP) →

Sponsor

AbbVie — full company profile →

Who can join

18 and older, any sex, with Palmoplantar Pustulosis (PPP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Palmoplantar pustulosis is a chronic inflammatory skin disease that causes repeated on and off symptoms like erythema (reddening, irritation), vesicle (swelling, cyst), pustules, scale, and crusts in palms and soles. This study evaluates how well risankizumab works compared to placebo (no medicine) to treat palmoplantar pustulosis. Study will assess change in Palmoplantar Pustulosis Area and Severity Index \[PPPASI\].

Risankizumab is an investigational drug being developed for the treatment of palmoplantar pustulosis. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given study drug and who will receive placebo (no medicine). Participants are randomly put into 1 of 2 groups, called treatment arms to receive risankizumab or placebo in period A. In period B, each group receives both risankizumab and placebo at different time intervals. Around 116 adult participants with palmoplantar pustulosis will be enrolled in approximately 39 sites across Japan.

Participants will receive subcutaneous (SC) injections of risankizumab or placebo at Week 0 and Week 4 (Period A). Beginning Week 16 (Period B), both the groups will receive risankizumab and placebo at different intervals. Total treatment duration is 56 weeks.

There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pustular Psoriasis: From Pathophysiology to Treatment.
   Genovese G, Moltrasio C, Cassano N, Maronese CA, et al · · 2021 · cited 40× · PMID 34944562 · DOI 10.3390/biomedicines9121746
2. Risankizumab in Japanese patients with moderate-to-severe palmoplantar pustulosis: Results from the randomized, phase 3 JumPPP study.
   Okubo Y, Murakami M, Kobayashi S, Tsuji S, et al · · 2025 · cited 5× · PMID 40001318 · DOI 10.1111/1346-8138.17659