Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis

Study Overview
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Brief Summary
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Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored. Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally. The study will be broken up into 2 sub-studies by disease location, participants with moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study S). In both sub-studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period. 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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A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for the Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis

Conditions
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Genital Psoriasis, Scalp 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: Must have clinical diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the baseline visit. Must have a current diagnosis of moderate to severe genital psoriasis (Study-G) defined as static Physician Global Assessment of Genitalia (sPGA-G) ≥ 3 or moderate to severe scalp psoriasis (Study-S) defined as Psoriasis Scalp Severity Index (PSSI) >= 12, scalp Investigator Global Assessment (IGA) >= 3, and >= 30% of the scalp affected. Must have body surface area (BSA) ≥ 1% with at least 60% of subjects having BSA ≥ 10%; sPGA ≥ 3; inadequate control of psoriasis and/or intolerance to topical treatment, phototherapy and/or systemic therapy; and be candidates for systemic therapy or phototherapy as assessed by the investigator. Exclusion Criteria: Had previous exposure to IL-23 inhibitors including but not limited to guselkumab, tildrakizumab, ustekinumab, mirikizumab, or risankizumab. History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class. Non-plaque forms of psoriasis or other active skin disease.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study G Risankizumab<br>Participants with moderate to severe genital psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period. | Drug: Risankizumab<br>* Subcutaneous injection<br>* Other names: ABBV-066;|
| Experimental: Study G Placebo for Risankizumab<br>Participants with moderate to severe genital psoriasis will receive placebo for risankizumab during the 16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period. | Drug: Risankizumab<br>* Subcutaneous injection<br>* Other names: ABBV-066;Drug: Placebo for Risankizumab<br>* Subcutaneous injection<br>|
| Experimental: Study S Risankizumab<br>Participants with moderate to severe scalp psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period. | Drug: Risankizumab<br>* Subcutaneous injection<br>* Other names: ABBV-066;|
| Experimental: Study S Placebo for Risankizumab<br>Participants with moderate to severe scalp psoriasis will receive placebo for risankizumab during the16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period. | Drug: Risankizumab<br>* Subcutaneous injection<br>* Other names: ABBV-066;Drug: Placebo for Risankizumab<br>* Subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 | The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions. | Week 16 | 
| Study-S: Percentage of Participants with Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1 | The scalp IGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The scalp IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0 | The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Week 16 | 
| Study-G: Percentage of Participants with Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1 | The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment) and has a 1-week recall period. The response options range from 0 (not affected at all) to 3 (very much affected). This gives an overall range of 0 to 30 where lower scores mean better quality of life. | Week 16 | 
| Study-G: Percentage of Participants with Achievement of Clinically Meaningful (>= 4-point) Improvement from Baseline on the Genital Psoriasis Itch Numerical Rating Scale (NRS) [Among Participants with a Baseline Score >= 4] | The scalp Itch NRS is a self-administered NRS that asks the patients to assess their scalp itch on a scale from 0 to 10 where 0 represents no itch and 10 represents worst imaginable itch. | Week 16 | 
| Study-G: Percentage of Participants with Achievement of Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 Among Participants with a Baseline score >= 2 | The GenPs-SFQ is a patient-reported outcome(s) [PRO] measure to evaluate the impact of genital psoriasis symptoms on sexual frequency, using a 1-week recall period. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Each item uses a Likert scale. Respondents are asked to answer the questions based on their psoriasis symptoms in the genital area. Genital area is defined as the labia majora (outer lip), labia minora (inner lip), and perineum (area between vagina and anus) for females; penis, scrotum, and perineum (area between the penis and anus) for males. | Week 16 | 
| Study-S: Percentage of Participants with Achievement of Psoriasis Scalp Severity Index (PSSI 90) | PPSI 90 is defined as >= 90% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72. | Week 16 | 
| Study-S: Percentage of Participants with Achievement of PSSI 75 | PPSI 75 is defined as >= 75% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72. | Week 16 | 
| Study-S: Change from Baseline in Psoriasis Symptom Scale (PSS) | The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis, using a recall period of 1 day. The symptoms include pain, redness, itching and burning from psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe). | Week 16 | 
| Study-S: Percentage of Participants with Achievement of PSSI 100 | PPSI 100 is defined as >= 100% improvement from baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72. | Week 16 | 
| Study-S: Percentage of Participants with Achievement of PSS of 0 | The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis, using a recall period of 1 day. The symptoms include pain, redness, itching and burning from psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe). | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genital Psoriasis, Scalp Psoriasis, Plaque Psoriasis, Psoriasis, ABBV066, Skyrizi, Risankizumab