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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- History of active skin disease other than PPP which could interfere with the assessment of PPP.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ichinomiya Municipal Hospital /ID# 222581 | Ichinomiya-shi | Aichi-ken | 491-8558 | Japan | ||
| Chukyo Hospital /ID# 218894 |
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| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
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| Placebo | Drug | Subcutaneous (SC) injection |
|
| Baseline (Week 0) through Week 16 |
| 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. | Baseline (Week 0) through Week 16 |
| Nagoya |
| Aichi-ken |
| 457-8510 |
| Japan |
| Nagoya City University Hospital /ID# 221258 | Nagoya | Aichi-ken | 467-8602 | Japan |
| Fujita Health University Hospital /ID# 221285 | Toyoake-shi | Aichi-ken | 470-1192 | Japan |
| Toho University Sakura Medical Center /ID# 220858 | Sakura-shi | Chiba | 285-8741 | Japan |
| Ehime University Hospital /ID# 221260 | Toon-shi | Ehime | 791-0295 | Japan |
| Kurume University Hospital /ID# 222751 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Fukushima Medical University Hospital /ID# 221639 | Fukushima | Fukushima | 960-1295 | Japan |
| Gifu University Hospital /ID# 219109 | Gifu | Gifu | 501-1194 | Japan |
| Ogaki Municipal Hospital /ID# 220801 | Ogaki-shi | Gifu | 503-8502 | Japan |
| Takagi Dermatology Clinic /ID# 220896 | Obihiro-shi | Hokkaido | 080-0013 | Japan |
| Bito Dermatology Clinic /ID# 222750 | Kobe | Hyōgo | 651-0095 | Japan |
| Meiwa Hospital /ID# 221633 | Nishinomiya-shi | Hyōgo | 663-8186 | Japan |
| Ibaraki Prefectural Central Hospital /ID# 222712 | Kasama-shi | Ibaraki | 309-1793 | Japan |
| Mito Kyodo General Hospital /ID# 220799 | Mito | Ibaraki | 310-0015 | Japan |
| Takamatsu Red Cross Hospital /ID# 221344 | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Tokai University Hospital /ID# 220945 | Isehara-shi | Kanagawa | 259-1193 | Japan |
| National Hospital Organization Sagamihara National Hospital /ID# 219082 | Sagamihara-shi | Kanagawa | 252-0392 | Japan |
| Yokohama City University Hospital /ID# 220860 | Yokohama | Kanagawa | 236-0004 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID# 221376 | Kyoto | Kyoto | 602-8566 | Japan |
| National Hospital Organization Kyoto Medical Center /ID# 221772 | Kyoto | Kyoto | 612-8555 | Japan |
| Mie University Hospital /ID# 221570 | Tsu | Mie-ken | 514-8507 | Japan |
| Tohoku University Hospital /ID# 219017 | Sendai | Miyagi | 9808574 | Japan |
| Shinshu University Hospital /ID# 221343 | Matsumoto-shi | Nagano | 390-8621 | Japan |
| Nagasaki University Hospital /ID# 221141 | Nagasaki | Nagasaki | 852-8501 | Japan |
| Nagaoka Red Cross Hospital /ID# 221375 | Nagaoka-shi | Niigata | 940-2085 | Japan |
| Isonokami dermatological clinic /ID# 219023 | Daito-shi | Osaka | 574-0046 | Japan |
| Kansai Medical University Kori Hospital /ID# 223096 | Neyagawa | Osaka | 572-8551 | Japan |
| Osaka Metropolitan University Hospital /ID# 222012 | Osaka | Osaka | 545-8586 | Japan |
| Kindai University Hospital /ID# 219022 | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Kume Clinic /ID# 220869 | Sakai-shi | Osaka | 5938324 | Japan |
| Dokkyo Medical University Saitama Medical Center /ID# 222526 | Koshigaya-shi | Saitama | 343-8555 | Japan |
| Shizuoka Saiseikai Genaral Hospital /ID# 222427 | Shizuoka | Shizuoka | 422-8527 | Japan |
| Dokkyo Medical University Hospital /ID# 221210 | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| St.Luke's International Hospital /ID# 219019 | Chuo-ku | Tokyo | 104-8560 | Japan |
| Teikyo University Hospital /ID# 221089 | Itabashi-ku | Tokyo | 173-8606 | Japan |
| The Jikei University Hospital /ID# 218822 | Minato-ku | Tokyo | 105-8471 | Japan |
| Tokyo Medical University Hospital /ID# 218893 | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Seibo Hospital /ID# 221691 | Shinjuku-ku | Tokyo | 161-8521 | Japan |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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