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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04451720
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Palmoplantar Pustulosis (PPP)
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Interventions

Drug: - Risankizumab

Subcutaneous (SC) injection

Drug: - Placebo

Subcutaneous (SC) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ichinomiya-shi, Aichi, Japan

Status

Not yet recruiting

Address

Ichinomiya Municipal Hospital /ID# 222581

Ichinomiya-shi, Aichi, 491-8558

Chukyo Hospital /ID# 218894, Nagoya-shi, Aichi, Japan

Status

Recruiting

Address

Chukyo Hospital /ID# 218894

Nagoya-shi, Aichi, 457-8510

Nagoya-shi, Aichi, Japan

Status

Not yet recruiting

Address

Nagoya City University Hospital /ID# 221258

Nagoya-shi, Aichi, 467-8602

Toyoake-shi, Aichi, Japan

Status

Not yet recruiting

Address

Fujita Health University Hospital /ID# 221285

Toyoake-shi, Aichi, 470-1192

Sakura-shi, Chiba, Japan

Status

Recruiting

Address

Toho University Sakura Medical Center /ID# 220858

Sakura-shi, Chiba, 285-8741

Ehime University Hospital /ID# 221260, Toon-shi, Ehime, Japan

Status

Not yet recruiting

Address

Ehime University Hospital /ID# 221260

Toon-shi, Ehime, 791-0295

Kurume University Hospital /ID# 222751, Kurume-shi, Fukuoka, Japan

Status

Not yet recruiting

Address

Kurume University Hospital /ID# 222751

Kurume-shi, Fukuoka, 830-0011

Fukushima-shi, Fukushima, Japan

Status

Not yet recruiting

Address

Fukushima Medical University Hospital /ID# 221639

Fukushima-shi, Fukushima, 960-1295

Gifu University Hospital /ID# 219109, Gifu-shi, Gifu, Japan

Status

Recruiting

Address

Gifu University Hospital /ID# 219109

Gifu-shi, Gifu, 501-1194

Ogaki Municipal Hospital /ID# 220801, Ogaki-shi, Gifu, Japan

Status

Recruiting

Address

Ogaki Municipal Hospital /ID# 220801

Ogaki-shi, Gifu, 503-8502

Takagi Dermatological Clinic /ID# 220896, Obihiro-shi, Hokkaido, Japan

Status

Recruiting

Address

Takagi Dermatological Clinic /ID# 220896

Obihiro-shi, Hokkaido, 080-0013

Bito Dermatology Clinic /ID# 222750, Kobe-shi, Hyogo, Japan

Status

Recruiting

Address

Bito Dermatology Clinic /ID# 222750

Kobe-shi, Hyogo, 651-0095

Kasama, Ibaraki, Japan

Status

Recruiting

Address

Ibaraki Prefectural Central Hospital /ID# 222712

Kasama, Ibaraki, 309-1793

Mito Kyodo General Hospital /ID# 220799, Mito-shi, Ibaraki, Japan

Status

Recruiting

Address

Mito Kyodo General Hospital /ID# 220799

Mito-shi, Ibaraki, 310-0015

Takamatsu Red Cross Hospital /ID# 221344, Takamatsu-shi, Kagawa, Japan

Status

Recruiting

Address

Takamatsu Red Cross Hospital /ID# 221344

Takamatsu-shi, Kagawa, 760-0017

Tokai University Hospital /ID# 220945, Isehara-shi, Kanagawa, Japan

Status

Not yet recruiting

Address

Tokai University Hospital /ID# 220945

Isehara-shi, Kanagawa, 259-1193

Sagamihara-shi, Kanagawa, Japan

Status

Recruiting

Address

National Hospital Organization Sagamihara National Hospital /ID# 219082

Sagamihara-shi, Kanagawa, 252-0392

Yokohama-shi, Kanagawa, Japan

Status

Not yet recruiting

Address

Yokohama City University Hospital /ID# 220860

Yokohama-shi, Kanagawa, 236-0004

Kyoto-shi, Kyoto, Japan

Status

Recruiting

Address

University Hospital Kyoto Prefectural University of Medicine /ID# 221376

Kyoto-shi, Kyoto, 602-8566

Mie University Hospital /ID# 221570, Tsu-shi, Mie, Japan

Status

Recruiting

Address

Mie University Hospital /ID# 221570

Tsu-shi, Mie, 514-8507

Tohoku University Hospital /ID# 219017, Sendai-shi, Miyagi, Japan

Status

Recruiting

Address

Tohoku University Hospital /ID# 219017

Sendai-shi, Miyagi, 980-8574

Shinshu University Hospital /ID# 221343, Matsumoto-shi, Nagano, Japan

Status

Recruiting

Address

Shinshu University Hospital /ID# 221343

Matsumoto-shi, Nagano, 390-8621

Nagasaki University Hospital /ID# 221141, Nagasaki-shi, Nagasaki, Japan

Status

Recruiting

Address

Nagasaki University Hospital /ID# 221141

Nagasaki-shi, Nagasaki, 852-8501

Nagaoka Red Cross Hospital /ID# 221375, Nagaoka-shi, Niigata, Japan

Status

Recruiting

Address

Nagaoka Red Cross Hospital /ID# 221375

Nagaoka-shi, Niigata, 940-2108

Daito-shi, Osaka, Japan

Status

Recruiting

Address

Isonokami dermatological clinic /ID# 219023

Daito-shi, Osaka, 5740046

Neyagawa, Osaka, Japan

Status

Recruiting

Address

Kansai Medical Univ Kori Hosp /ID# 223096

Neyagawa, Osaka, 572-8551

Kindai University Hospital /ID# 219022, Osaka-sayama-shi, Osaka, Japan

Status

Not yet recruiting

Address

Kindai University Hospital /ID# 219022

Osaka-sayama-shi, Osaka, 589-8511

Osaka-shi, Osaka, Japan

Status

Recruiting

Address

Osaka City University Hospital /ID# 222012

Osaka-shi, Osaka, 545-8586

Kume Clinic /ID# 220869, Sakai-shi, Osaka, Japan

Status

Recruiting

Address

Kume Clinic /ID# 220869

Sakai-shi, Osaka, 5938324

Koshigaya-shi, Saitama, Japan

Status

Not yet recruiting

Address

Dokkyo Medical University Saitama Medical Center /ID# 222526

Koshigaya-shi, Saitama, 343-8555

Shizuoka-shi, Shizuoka, Japan

Status

Recruiting

Address

Shizuoka Saiseikai Genaral Hospital /ID# 222427

Shizuoka-shi, Shizuoka, 422-8021

Shimotsuga-gun, Tochigi, Japan

Status

Recruiting

Address

Dokkyo Medical University Hospital /ID# 221210

Shimotsuga-gun, Tochigi, 321-0293

Chuo-ku, Tokyo, Japan

Status

Recruiting

Address

St.Luke's International Hospital /ID# 219019

Chuo-ku, Tokyo, 104-8560

Teikyo University Hospital /ID# 221089, Itabashi-ku, Tokyo, Japan

Status

Not yet recruiting

Address

Teikyo University Hospital /ID# 221089

Itabashi-ku, Tokyo, 173-8606

Minato-ku, Tokyo, Japan

Status

Not yet recruiting

Address

The Jikei University Hospital /ID# 218822

Minato-ku, Tokyo, 105-8471

Shinjuku-ku, Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical University Hospital /ID# 218893

Shinjuku-ku, Tokyo, 160-0023

Seibo Hospital /ID# 221691, Shinjuku-ku, Tokyo, Japan

Status

Recruiting

Address

Seibo Hospital /ID# 221691

Shinjuku-ku, Tokyo, 161-8521

NHO Kyoto Medical Center /ID# 221772, Kyoto, Japan

Status

Not yet recruiting

Address

NHO Kyoto Medical Center /ID# 221772

Kyoto, , 612-0861

Meiwa Hospital /ID# 221633, Nishinomiya, Hyogo, Japan

Status

Recruiting

Address

Meiwa Hospital /ID# 221633

Nishinomiya, Hyogo, , 663-8186

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