Back to resultsStudy of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis
Primary Purpose
Palmoplantar Pustulosis (PPP)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Risankizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Palmoplantar Pustulosis (PPP) focused on measuring Palmoplantar Pustulosis (PPP), Risankizumab, SKYRIZI
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.
Sites / Locations
- Ichinomiya Municipal Hospital /ID# 222581
- Nagoya City University Hospital /ID# 221258
- Chukyo Hospital /ID# 218894
- Fujita Health University Hospital /ID# 221285
- Toho University Sakura Medical Center /ID# 220858
- Ehime University Hospital /ID# 221260
- Kurume University Hospital /ID# 222751
- Fukushima Medical University Hospital /ID# 221639
- Gifu University Hospital /ID# 219109
- Ogaki Municipal Hospital /ID# 220801
- Takagi Dermatology Clinic /ID# 220896
- Bito Dermatology Clinic /ID# 222750
- Meiwa Hospital /ID# 221633
- Ibaraki Prefectural Central Hospital /ID# 222712
- Mito Kyodo General Hospital /ID# 220799
- Takamatsu Red Cross Hospital /ID# 221344
- Tokai University Hospital /ID# 220945
- National Hospital Organization Sagamihara National Hospital /ID# 219082
- Yokohama City University Hospital /ID# 220860
- University Hospital Kyoto Prefectural University of Medicine /ID# 221376
- National Hospital Organization Kyoto Medical Center /ID# 221772
- Mie University Hospital /ID# 221570
- Tohoku University Hospital /ID# 219017
- Shinshu University Hospital /ID# 221343
- Nagasaki University Hospital /ID# 221141
- Nagaoka Red Cross Hospital /ID# 221375
- Isonokami dermatological clinic /ID# 219023
- Kansai Medical University Kori Hospital /ID# 223096
- Osaka Metropolitan University Hospital /ID# 222012
- Kindai University Hospital /ID# 219022
- Kume Clinic /ID# 220869
- Dokkyo Medical University Saitama Medical Center /ID# 222526
- Shizuoka Saiseikai Genaral Hospital /ID# 222427
- Dokkyo Medical University Hospital /ID# 221210
- St.Luke's International Hospital /ID# 219019
- Teikyo University Hospital /ID# 221089
- The Jikei University Hospital /ID# 218822
- Tokyo Medical University Hospital /ID# 218893
- Seibo Hospital /ID# 221691
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Risankizumab
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04451720
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Pustulosis (PPP)
Keywords
Palmoplantar Pustulosis (PPP), Risankizumab, SKYRIZI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risankizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
SKYRIZI, ABBV-066
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score
Description
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.
Time Frame
Baseline (Week 0) through Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50)
Description
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.
Time Frame
Baseline (Week 0) through Week 16
Title
Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)
Description
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.
Time Frame
Baseline (Week 0) through Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Ichinomiya Municipal Hospital /ID# 222581
City
Ichinomiya-shi
State/Province
Aichi
ZIP/Postal Code
491-8558
Country
Japan
Facility Name
Nagoya City University Hospital /ID# 221258
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Chukyo Hospital /ID# 218894
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
Facility Name
Fujita Health University Hospital /ID# 221285
City
Toyoake-shi
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Toho University Sakura Medical Center /ID# 220858
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Ehime University Hospital /ID# 221260
City
Toon-shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kurume University Hospital /ID# 222751
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Fukushima Medical University Hospital /ID# 221639
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gifu University Hospital /ID# 219109
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Ogaki Municipal Hospital /ID# 220801
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Takagi Dermatology Clinic /ID# 220896
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Bito Dermatology Clinic /ID# 222750
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
651-0095
Country
Japan
Facility Name
Meiwa Hospital /ID# 221633
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8186
Country
Japan
Facility Name
Ibaraki Prefectural Central Hospital /ID# 222712
City
Kasama-shi
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Mito Kyodo General Hospital /ID# 220799
City
Mito-shi
State/Province
Ibaraki
ZIP/Postal Code
310-0015
Country
Japan
Facility Name
Takamatsu Red Cross Hospital /ID# 221344
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
Tokai University Hospital /ID# 220945
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
National Hospital Organization Sagamihara National Hospital /ID# 219082
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
Yokohama City University Hospital /ID# 220860
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine /ID# 221376
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
National Hospital Organization Kyoto Medical Center /ID# 221772
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Mie University Hospital /ID# 221570
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Tohoku University Hospital /ID# 219017
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Shinshu University Hospital /ID# 221343
City
Matsumoto-shi
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Nagasaki University Hospital /ID# 221141
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Nagaoka Red Cross Hospital /ID# 221375
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Isonokami dermatological clinic /ID# 219023
City
Daito-shi
State/Province
Osaka
ZIP/Postal Code
574-0046
Country
Japan
Facility Name
Kansai Medical University Kori Hospital /ID# 223096
City
Neyagawa-shi
State/Province
Osaka
ZIP/Postal Code
572-8551
Country
Japan
Facility Name
Osaka Metropolitan University Hospital /ID# 222012
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Kindai University Hospital /ID# 219022
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Kume Clinic /ID# 220869
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
5938324
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center /ID# 222526
City
Koshigaya-shi
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Shizuoka Saiseikai Genaral Hospital /ID# 222427
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
422-8527
Country
Japan
Facility Name
Dokkyo Medical University Hospital /ID# 221210
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
St.Luke's International Hospital /ID# 219019
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Teikyo University Hospital /ID# 221089
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
The Jikei University Hospital /ID# 218822
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Tokyo Medical University Hospital /ID# 218893
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Seibo Hospital /ID# 221691
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
161-8521
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis
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