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

Palmoplantar Pustulosis (PPP) Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult Japanese Subjects With Moderate to Severe Palmoplantar Pustulosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451720
• Other study ID #: M19-135
• Status: Completed
• Phase: Phase 3
• Start date: July 20, 2020
• Est. completion date: November 21, 2022

Study information

• Verified date: December 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Palmoplantar Pustulosis (PPP)
• Psoriasis

Intervention

Drug:
• Risankizumab
Subcutaneous (SC) injection
• Placebo
Subcutaneous (SC) injection

Locations

Country	Name	City	State
Japan	St.Luke's International Hospital /ID# 219019	Chuo-ku	Tokyo
Japan	Isonokami dermatological clinic /ID# 219023	Daito-shi	Osaka
Japan	Fukushima Medical University Hospital /ID# 221639	Fukushima-shi	Fukushima
Japan	Gifu University Hospital /ID# 219109	Gifu-shi	Gifu
Japan	Ichinomiya Municipal Hospital /ID# 222581	Ichinomiya-shi	Aichi
Japan	Tokai University Hospital /ID# 220945	Isehara-shi	Kanagawa
Japan	Teikyo University Hospital /ID# 221089	Itabashi-ku	Tokyo
Japan	Ibaraki Prefectural Central Hospital /ID# 222712	Kasama-shi	Ibaraki
Japan	Bito Dermatology Clinic /ID# 222750	Kobe-shi	Hyogo
Japan	Dokkyo Medical University Saitama Medical Center /ID# 222526	Koshigaya-shi	Saitama
Japan	Kurume University Hospital /ID# 222751	Kurume-shi	Fukuoka
Japan	National Hospital Organization Kyoto Medical Center /ID# 221772	Kyoto-shi	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 221376	Kyoto-shi	Kyoto
Japan	Shinshu University Hospital /ID# 221343	Matsumoto-shi	Nagano
Japan	The Jikei University Hospital /ID# 218822	Minato-ku	Tokyo
Japan	Mito Kyodo General Hospital /ID# 220799	Mito-shi	Ibaraki
Japan	Nagaoka Red Cross Hospital /ID# 221375	Nagaoka-shi	Niigata
Japan	Nagasaki University Hospital /ID# 221141	Nagasaki-shi	Nagasaki
Japan	Nagoya City University Hospital /ID# 221258	Nagoya shi	Aichi
Japan	Chukyo Hospital /ID# 218894	Nagoya-shi	Aichi
Japan	Kansai Medical University Kori Hospital /ID# 223096	Neyagawa-shi	Osaka
Japan	Meiwa Hospital /ID# 221633	Nishinomiya-shi	Hyogo
Japan	Takagi Dermatology Clinic /ID# 220896	Obihiro-shi	Hokkaido
Japan	Ogaki Municipal Hospital /ID# 220801	Ogaki-shi	Gifu
Japan	Osaka Metropolitan University Hospital /ID# 222012	Osaka-shi	Osaka
Japan	Kindai University Hospital /ID# 219022	Osakasayama-shi	Osaka
Japan	National Hospital Organization Sagamihara National Hospital /ID# 219082	Sagamihara-shi	Kanagawa
Japan	Kume Clinic /ID# 220869	Sakai-shi	Osaka
Japan	Toho University Sakura Medical Center /ID# 220858	Sakura-shi	Chiba
Japan	Tohoku University Hospital /ID# 219017	Sendai-shi	Miyagi
Japan	Dokkyo Medical University Hospital /ID# 221210	Shimotsuga-gun	Tochigi
Japan	Seibo Hospital /ID# 221691	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital /ID# 218893	Shinjuku-ku	Tokyo
Japan	Shizuoka Saiseikai Genaral Hospital /ID# 222427	Shizuoka-shi	Shizuoka
Japan	Takamatsu Red Cross Hospital /ID# 221344	Takamatsu-shi	Kagawa
Japan	Ehime University Hospital /ID# 221260	Toon-shi	Ehime
Japan	Fujita Health University Hospital /ID# 221285	Toyoake-shi	Aichi
Japan	Mie University Hospital /ID# 221570	Tsu-shi	Mie
Japan	Yokohama City University Hospital /ID# 220860	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score	The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline (Week 0) through Week 16
Secondary	Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50)	The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline (Week 0) through Week 16
Secondary	Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)	The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline (Week 0) through Week 16

External Links

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