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

NCT04451720 | Completed Phase 3

• 1 other identifier: M19-135
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 39

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)

Keywords

Palmoplantar Pustulosis (PPP); Risankizumab; SKYRIZI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50)

  Baseline (Week 0) through Week 16

• Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)

  Baseline (Week 0) through Week 16

Study Arms (2)

Risankizumab

EXPERIMENTAL

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.

Drug: Risankizumab; Drug: Placebo

Placebo

EXPERIMENTAL

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.

Drug: Risankizumab; Drug: Placebo

Interventions

Risankizumab DRUG

Subcutaneous (SC) injection

Also known as: SKYRIZI, ABBV-066

Placebo; Risankizumab

Placebo DRUG

Subcutaneous (SC) injection

Placebo; Risankizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (39)

Ichinomiya Municipal Hospital /ID# 222581

Ichinomiya-shi, Aichi-ken, 491-8558, Japan

Location

Chukyo Hospital /ID# 218894

Nagoya, Aichi-ken, 457-8510, Japan

Location

Nagoya City University Hospital /ID# 221258

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fujita Health University Hospital /ID# 221285

Toyoake-shi, Aichi-ken, 470-1192, Japan

Location

Toho University Sakura Medical Center /ID# 220858

Sakura-shi, Chiba, 285-8741, Japan

Location

Ehime University Hospital /ID# 221260

Toon-shi, Ehime, 791-0295, Japan

Location

Kurume University Hospital /ID# 222751

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Fukushima Medical University Hospital /ID# 221639

Fukushima, Fukushima, 960-1295, Japan

Location

Gifu University Hospital /ID# 219109

Gifu, Gifu, 501-1194, Japan

Location

Ogaki Municipal Hospital /ID# 220801

Ogaki-shi, Gifu, 503-8502, Japan

Location

Takagi Dermatology Clinic /ID# 220896

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Bito Dermatology Clinic /ID# 222750

Kobe, Hyōgo, 651-0095, Japan

Location

Meiwa Hospital /ID# 221633

Nishinomiya-shi, Hyōgo, 663-8186, Japan

Location

Ibaraki Prefectural Central Hospital /ID# 222712

Kasama-shi, Ibaraki, 309-1793, Japan

Location

Mito Kyodo General Hospital /ID# 220799

Mito, Ibaraki, 310-0015, Japan

Location

Takamatsu Red Cross Hospital /ID# 221344

Takamatsu, Kagawa-ken, 760-0017, Japan

Location

Tokai University Hospital /ID# 220945

Isehara-shi, Kanagawa, 259-1193, Japan

Location

National Hospital Organization Sagamihara National Hospital /ID# 219082

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

Yokohama City University Hospital /ID# 220860

Yokohama, Kanagawa, 236-0004, Japan

Location

University Hospital Kyoto Prefectural University of Medicine /ID# 221376

Kyoto, Kyoto, 602-8566, Japan

Location

National Hospital Organization Kyoto Medical Center /ID# 221772

Kyoto, Kyoto, 612-8555, Japan

Location

Mie University Hospital /ID# 221570

Tsu, Mie-ken, 514-8507, Japan

Location

Tohoku University Hospital /ID# 219017

Sendai, Miyagi, 9808574, Japan

Location

Shinshu University Hospital /ID# 221343

Matsumoto-shi, Nagano, 390-8621, Japan

Location

Nagasaki University Hospital /ID# 221141

Nagasaki, Nagasaki, 852-8501, Japan

Location

Nagaoka Red Cross Hospital /ID# 221375

Nagaoka-shi, Niigata, 940-2085, Japan

Location

Isonokami dermatological clinic /ID# 219023

Daito-shi, Osaka, 574-0046, Japan

Location

Kansai Medical University Kori Hospital /ID# 223096

Neyagawa, Osaka, 572-8551, Japan

Location

Osaka Metropolitan University Hospital /ID# 222012

Osaka, Osaka, 545-8586, Japan

Location

Kindai University Hospital /ID# 219022

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Kume Clinic /ID# 220869

Sakai-shi, Osaka, 5938324, Japan

Location

Dokkyo Medical University Saitama Medical Center /ID# 222526

Koshigaya-shi, Saitama, 343-8555, Japan

Location

Shizuoka Saiseikai Genaral Hospital /ID# 222427

Shizuoka, Shizuoka, 422-8527, Japan

Location

Dokkyo Medical University Hospital /ID# 221210

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

St.Luke's International Hospital /ID# 219019

Chuo-ku, Tokyo, 104-8560, Japan

Location

Teikyo University Hospital /ID# 221089

Itabashi-ku, Tokyo, 173-8606, Japan

Location

The Jikei University Hospital /ID# 218822

Minato-ku, Tokyo, 105-8471, Japan

Location

Tokyo Medical University Hospital /ID# 218893

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Seibo Hospital /ID# 221691

Shinjuku-ku, Tokyo, 161-8521, Japan

Location

Related Links

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

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: June 30, 2020
• Study Start: July 20, 2020
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (39)