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

NCT ID: NCT04451720

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2022-11-21

Brief Summary

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.

Conditions

Palmoplantar Pustulosis (PPP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Risankizumab

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.

Group Type: EXPERIMENTAL

Risankizumab

Intervention Type: DRUG

Subcutaneous (SC) injection

Placebo

Intervention Type: DRUG

Subcutaneous (SC) injection

Placebo

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.

Group Type: EXPERIMENTAL

Risankizumab

Intervention Type: DRUG

Subcutaneous (SC) injection

Placebo

Intervention Type: DRUG

Subcutaneous (SC) injection

Interventions

Risankizumab

Subcutaneous (SC) injection

Intervention Type: DRUG

Placebo

Subcutaneous (SC) injection

Intervention Type: DRUG

Other Intervention Names

SKYRIZI; ABBV-066

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Ichinomiya Municipal Hospital /ID# 222581

Ichinomiya-shi, Aichi-ken, Japan

Chukyo Hospital /ID# 218894

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital /ID# 221258

Nagoya, Aichi-ken, Japan

Fujita Health University Hospital /ID# 221285

Toyoake-shi, Aichi-ken, Japan

Toho University Sakura Medical Center /ID# 220858

Sakura-shi, Chiba, Japan

Ehime University Hospital /ID# 221260

Toon-shi, Ehime, Japan

Kurume University Hospital /ID# 222751

Kurume-shi, Fukuoka, Japan

Fukushima Medical University Hospital /ID# 221639

Fukushima, Fukushima, Japan

Gifu University Hospital /ID# 219109

Gifu, Gifu, Japan

Ogaki Municipal Hospital /ID# 220801

Ogaki-shi, Gifu, Japan

Takagi Dermatology Clinic /ID# 220896

Obihiro-shi, Hokkaido, Japan

Bito Dermatology Clinic /ID# 222750

Kobe, Hyōgo, Japan

Meiwa Hospital /ID# 221633

Nishinomiya-shi, Hyōgo, Japan

Ibaraki Prefectural Central Hospital /ID# 222712

Kasama-shi, Ibaraki, Japan

Mito Kyodo General Hospital /ID# 220799

Mito, Ibaraki, Japan

Takamatsu Red Cross Hospital /ID# 221344

Takamatsu, Kagawa-ken, Japan

Tokai University Hospital /ID# 220945

Isehara-shi, Kanagawa, Japan

National Hospital Organization Sagamihara National Hospital /ID# 219082

Sagamihara-shi, Kanagawa, Japan

Yokohama City University Hospital /ID# 220860

Yokohama, Kanagawa, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 221376

Kyoto, Kyoto, Japan

National Hospital Organization Kyoto Medical Center /ID# 221772

Kyoto, Kyoto, Japan

Mie University Hospital /ID# 221570

Tsu, Mie-ken, Japan

Tohoku University Hospital /ID# 219017

Sendai, Miyagi, Japan

Shinshu University Hospital /ID# 221343

Matsumoto-shi, Nagano, Japan

Nagasaki University Hospital /ID# 221141

Nagasaki, Nagasaki, Japan

Nagaoka Red Cross Hospital /ID# 221375

Nagaoka-shi, Niigata, Japan

Isonokami dermatological clinic /ID# 219023

Daito-shi, Osaka, Japan

Kansai Medical University Kori Hospital /ID# 223096

Neyagawa, Osaka, Japan

Osaka Metropolitan University Hospital /ID# 222012

Osaka, Osaka, Japan

Kindai University Hospital /ID# 219022

Osakasayama-shi, Osaka, Japan

Kume Clinic /ID# 220869

Sakai-shi, Osaka, Japan

Dokkyo Medical University Saitama Medical Center /ID# 222526

Koshigaya-shi, Saitama, Japan

Shizuoka Saiseikai Genaral Hospital /ID# 222427

Shizuoka, Shizuoka, Japan

Dokkyo Medical University Hospital /ID# 221210

Shimotsuga-gun, Tochigi, Japan

St.Luke's International Hospital /ID# 219019

Chuo-ku, Tokyo, Japan

Teikyo University Hospital /ID# 221089

Itabashi-ku, Tokyo, Japan

The Jikei University Hospital /ID# 218822

Minato-ku, Tokyo, Japan

Tokyo Medical University Hospital /ID# 218893

Shinjuku-ku, Tokyo, Japan

Seibo Hospital /ID# 221691

Shinjuku-ku, Tokyo, Japan

Countries

Japan

Related Links

https://www.rxabbvie.com/

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Other Identifiers

M19-135

Identifier Type: -

Identifier Source: org_study_id