Clinical trial NCT04451720: Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Palmoplantar Pustulosis (PPP)
Keywords: Palmoplantar Pustulosis (PPP)
Risankizumab
SKYRIZI
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score
timeFrame: Baseline (Week 0) through Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50)
timeFrame: Baseline (Week 0) through Week 16
measure: Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)
timeFrame: Baseline (Week 0) through Week 16
Other outcomes:
Locations:
city: Ichinomiya-shi
country: Japan
facility: Ichinomiya Municipal Hospital /ID# 222581
state: Aichi
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 221258
state: Aichi
city: Nagoya-shi
country: Japan
facility: Chukyo Hospital /ID# 218894
state: Aichi
city: Toyoake-shi
country: Japan
facility: Fujita Health University Hospital /ID# 221285
state: Aichi
city: Sakura-shi
country: Japan
facility: Toho University Sakura Medical Center /ID# 220858
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital /ID# 221260
state: Ehime
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 222751
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 221639
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu University Hospital /ID# 219109
state: Gifu
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital /ID# 220801
state: Gifu
city: Obihiro-shi
country: Japan
facility: Takagi Dermatology Clinic /ID# 220896
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Bito Dermatology Clinic /ID# 222750
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Meiwa Hospital /ID# 221633
state: Hyogo
city: Kasama-shi
country: Japan
facility: Ibaraki Prefectural Central Hospital /ID# 222712
state: Ibaraki
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital /ID# 220799
state: Ibaraki
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital /ID# 221344
state: Kagawa
city: Isehara-shi
country: Japan
facility: Tokai University Hospital /ID# 220945
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: National Hospital Organization Sagamihara National Hospital /ID# 219082
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital /ID# 220860
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 221376
state: Kyoto
city: Kyoto-shi
country: Japan
facility: National Hospital Organization Kyoto Medical Center /ID# 221772
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 221570
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 219017
state: Miyagi
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital /ID# 221343
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 221141
state: Nagasaki
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital /ID# 221375
state: Niigata
city: Daito-shi
country: Japan
facility: Isonokami dermatological clinic /ID# 219023
state: Osaka
city: Neyagawa-shi
country: Japan
facility: Kansai Medical University Kori Hospital /ID# 223096
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 222012
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 219022
state: Osaka
city: Sakai-shi
country: Japan
facility: Kume Clinic /ID# 220869
state: Osaka
city: Koshigaya-shi
country: Japan
facility: Dokkyo Medical University Saitama Medical Center /ID# 222526
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Shizuoka Saiseikai Genaral Hospital /ID# 222427
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital /ID# 221210
state: Tochigi
city: Chuo-ku
country: Japan
facility: St.Luke's International Hospital /ID# 219019
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital /ID# 221089
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital /ID# 218822
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 218893
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Seibo Hospital /ID# 221691
state: Tokyo
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: