Trial Outcomes & Findings for Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis (NCT NCT05969223)

This study was conducted at 30 sites in the United States with a total of 214 participants and was initiated in August 2023. Adults with with moderate to severe genital (Study-G) or scalp (Study-S) psoriasis were eligible.

Participants within Study-G and Study-S were randomized to receive risankizumab or placebo in a 1:1 ratio. Those meeting criteria for both Study-G and Study-S were first randomized to either Study-G or Study-S and then to receive either risankizumab or placebo. Participants received 150 mg of risankizumab or matching placebo subcutaneously at Weeks 0 and 4 during Period A. During Period B, all participants received/will continue to receive open-label 150 mg risankizumab at Weeks 16, 28, and 40.

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

The sPGA-G is a 6-point score ranging from 0 to 5, with a higher score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.

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. Higher scores indicate more severe disease.

The sPGA-G is a 6-point score ranging from 0 to 5, with a higher score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

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.

The scalp Itch NRS is a self-administered NRS that asks participants to assess their scalp itch on a scale from 0 to 10 where 0 represents no itch and 10 represents worst imaginable itch.

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. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with response options ranging from 0 (never) to 4 (always).

PSSI 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 1 (\<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, with higher scores indicating more severe disease.

PSSI 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 1 (\<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, with higher scores indicating more severe disease.

The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in participants 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), with total scores, which is the sum of the four item responses, ranging from 0 to 16 and higher scores indicating worse symptoms. Negative changes from Baseline indicate improvement.

PSSI 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 1 (\<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, with higher scores indicating more severe disease.

The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in participants 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).