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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Palmoplantar Pustulosis (PPP)

Treatments: Drug: Risankizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04451720

M19-135

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable moderate to severe Palmoplantar Pustulosis (PPP) with a Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score of >= 12 at the Screening and Baseline Visits.
• Moderate or severe pustules/vesicles on at least one palm or sole (>= 2 PPPASI severity score) at the Screening and Baseline Visits.
• Experienced inadequate response (or intolerant) to treatment with topical corticosteroids and/or vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate.

Exclusion criteria

• History of active skin disease other than PPP which could interfere with the assessment of PPP.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 2 patient groups

Risankizumab

Experimental group

Description:

In Period A, participants will receive risankizumab dose A at Weeks 0 and 4. In Period B, participants will receive risankizumab dose A at Weeks 16, 28, 40 and 52, and also placebo at Weeks 20, 32, 44 and 56.

Treatment:

Drug: Placebo

Drug: Risankizumab

Placebo

Experimental group

Description:

In Period A, participants will receive placebo at Weeks 0 and 4. In period B, participants will receive risankizumab dose A at Weeks 16, 20,32,44 and 56. and also placebo at Weeks 28,40 and 52.

Treatment:

Drug: Placebo

Drug: Risankizumab