A Phase 3 interventional study of Risankizumab and Placebo in Palmoplantar Pustulosis (PPP), sponsored by AbbVie. Completed at 39 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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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Exclusion Criteria:
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
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
Subcutaneous (SC) injection
Also known as: SKYRIZI, ABBV-066
Subcutaneous (SC) injection
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.
Time frame: Baseline (Week 0) through Week 16
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.
Time frame: 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.
Time frame: Baseline (Week 0) through Week 16
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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