Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis
- Registration Number
- NCT04451720
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- 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.
- History of active skin disease other than PPP which could interfere with the assessment of PPP.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Risankizumab 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. Placebo 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. Risankizumab 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. Risankizumab Placebo 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score Baseline (Week 0) through Week 16 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50) Baseline (Week 0) through Week 16 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.
Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75) Baseline (Week 0) through Week 16 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.
Trial Locations
- Locations (39)
St.Luke's International Hospital /ID# 219019
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 218893
🇯🇵Shinjuku-ku, Tokyo, Japan
Seibo Hospital /ID# 221691
🇯🇵Shinjuku-ku, Tokyo, Japan
Kurume University Hospital /ID# 222751
🇯🇵Kurume-shi, Fukuoka, Japan
Chukyo Hospital /ID# 218894
🇯🇵Nagoya-shi, Aichi, 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-shi, Hyogo, Japan
Meiwa Hospital /ID# 221633
🇯🇵Nishinomiya-shi, Hyogo, Japan
Ibaraki Prefectural Central Hospital /ID# 222712
🇯🇵Kasama-shi, Ibaraki, Japan
Takamatsu Red Cross Hospital /ID# 221344
🇯🇵Takamatsu-shi, Kagawa, Japan
Tokai University Hospital /ID# 220945
🇯🇵Isehara-shi, Kanagawa, Japan
Mito Kyodo General Hospital /ID# 220799
🇯🇵Mito-shi, Ibaraki, Japan
National Hospital Organization Sagamihara National Hospital /ID# 219082
🇯🇵Sagamihara-shi, Kanagawa, Japan
Yokohama City University Hospital /ID# 220860
🇯🇵Yokohama-shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 221376
🇯🇵Kyoto-shi, Kyoto, Japan
Isonokami dermatological clinic /ID# 219023
🇯🇵Daito-shi, Osaka, Japan
Mie University Hospital /ID# 221570
🇯🇵Tsu-shi, Mie, Japan
Kansai Medical University Kori Hospital /ID# 223096
🇯🇵Neyagawa-shi, Osaka, Japan
Kindai University Hospital /ID# 219022
🇯🇵Osakasayama-shi, Osaka, Japan
Kume Clinic /ID# 220869
🇯🇵Sakai-shi, Osaka, Japan
Shizuoka Saiseikai Genaral Hospital /ID# 222427
🇯🇵Shizuoka-shi, Shizuoka, Japan
Dokkyo Medical University Hospital /ID# 221210
🇯🇵Shimotsuga-gun, Tochigi, Japan
Toho University Sakura Medical Center /ID# 220858
🇯🇵Sakura-shi, Chiba, Japan
Fukushima Medical University Hospital /ID# 221639
🇯🇵Fukushima-shi, Fukushima, Japan
Ichinomiya Municipal Hospital /ID# 222581
🇯🇵Ichinomiya-shi, Aichi, Japan
Gifu University Hospital /ID# 219109
🇯🇵Gifu-shi, Gifu, Japan
Nagoya City University Hospital /ID# 221258
🇯🇵Nagoya shi, Aichi, Japan
Fujita Health University Hospital /ID# 221285
🇯🇵Toyoake-shi, Aichi, Japan
Shinshu University Hospital /ID# 221343
🇯🇵Matsumoto-shi, Nagano, Japan
Teikyo University Hospital /ID# 221089
🇯🇵Itabashi-ku, Tokyo, Japan
Nagaoka Red Cross Hospital /ID# 221375
🇯🇵Nagaoka-shi, Niigata, Japan
Ehime University Hospital /ID# 221260
🇯🇵Toon-shi, Ehime, Japan
Tohoku University Hospital /ID# 219017
🇯🇵Sendai-shi, Miyagi, Japan
Nagasaki University Hospital /ID# 221141
🇯🇵Nagasaki-shi, Nagasaki, Japan
Osaka Metropolitan University Hospital /ID# 222012
🇯🇵Osaka-shi, Osaka, Japan
Dokkyo Medical University Saitama Medical Center /ID# 222526
🇯🇵Koshigaya-shi, Saitama, Japan
The Jikei University Hospital /ID# 218822
🇯🇵Minato-ku, Tokyo, Japan
National Hospital Organization Kyoto Medical Center /ID# 221772
🇯🇵Kyoto-shi, Kyoto, Japan