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

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult Japanese Subjects with Moderate to Severe Palmoplantar Pustulosis [M19-135]

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225259

Enrollment

116

Registered

2020-07-02

Start date

2020-07-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

palmoplantar pusutulosis

Interventions

investigational material(s) Generic name etc : Risankizumab (Genetical Recombination) INN of investigational material : risankizumab Therapeutic category code : 639 Other biological preparations Dosag

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - History of active skin disease other than PPP which could interfere with the assessment of PPP.

Design outcomes

Primary

Measure	Time frame
efficacy Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score	—

Secondary

Measure	Time frame
efficacy Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50) efficacy Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)	—

Countries

Japan

Contacts

Public ContactContact for Patients and HCP

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026