Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Study Overview
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Brief Summary
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Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms. Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world. Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during 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.

Official Title
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IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO)

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Risankizumab
* Drug: Placebo for Risankizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline. Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles. Must be a candidate for systemic therapy as assessed by the investigator. Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments. Exclusion Criteria: History of PsO other than chronic plaque type PsO History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis. Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments. Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline. Prior exposure to risankizumab.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risankizumab<br>Participants will receive risankizumab for 52 weeks | Drug: Risankizumab<br>* Subcutaneous (SC) Injection<br>* Other names: SKYRIZI;|
| Placebo Comparator: Placebo<br>Participants will receive placebo for 16 weeks followed by risankizumab for 36 weeks. | Drug: Risankizumab<br>* Subcutaneous (SC) Injection<br>* Other names: SKYRIZI;Drug: Placebo for Risankizumab<br>* Subcutaneous (SC) Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of clear or almost clear (0 or 1) with at least a 2 point reduction from Baseline | The ppIGA is a 5 point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being clear and 1 being almost clear. | Baseline (Week 0) through Week 16 | 
| Number of Participants with Adverse Events | Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 20 weeks after last dose of study drug. | Baseline (Week 0) through 20 weeks after last dose of study drug (Up to 60 weeks total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving >= 75% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) response | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. | Baseline (Week 0) through Week 16 | 
| Percentage of Participants Achieving >= 90% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) response | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. | Baseline (Week 0) through Week 16 | 
| Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of clear or almost clear (0 or 1) with at least a 2 point reduction from Baseline | sPGA is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Baseline (Week 0) through Week 16 | 
| Percentage of Participants Achieving 100% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) response | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. | Baseline (Week 0) through Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Plaque Psoriasis, Moderate to Severe Plaque Psoriasis, Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement (PPPsO), Risankizumab, SKYRIZI, ABBV-066