Trial results for risankizumab (Skyrizi) in adult participants with genital or scalp psoriasis were posted on ClinicalTrials.gov on 2026-02-24. The study demonstrated significant improvements in both conditions, with a 57.0% response rate difference for genital psoriasis and a 47.0% response rate difference for scalp psoriasis compared to placebo.
Background
Psoriasis is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This condition can affect various body areas, including sensitive regions like the scalp and genitals, leading to significant discomfort and impact on quality of life. Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis.
Trial design
This completed Phase 4 trial (NCT05969223) enrolled 214 adult participants with moderate to severe Genital Psoriasis or moderate to severe Scalp Psoriasis. The study assessed the safety and efficacy of subcutaneously injected risankizumab compared to placebo. Key efficacy outcomes included the achievement of a Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 for genital psoriasis, and a Scalp Investigator Global Assessment (IGA) of 0 or 1 for scalp psoriasis, both measured at Week 16.
Key results
The trial results demonstrated statistically significant improvements for risankizumab across multiple efficacy endpoints at Week 16:
- For genital psoriasis (Study-G), 69.1% of participants treated with risankizumab achieved a Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1, compared to 13.0% in the placebo group. The response rate difference was 57.0% (95% Confidence Interval 42.3, 71.7), with a p-value of 0.0001.
- Also in Study-G, 50.9% of risankizumab-treated participants achieved an sPGA-G of 0, versus 5.6% for placebo. The response rate difference was 46.7% (95% Confidence Interval 32.6, 60.8), with a p-value of 0.0001.
- For scalp psoriasis (Study-S), 60.8% of participants receiving risankizumab achieved a Scalp Investigator Global Assessment (IGA) of 0 or 1, compared to 13.0% in the placebo group. The response rate difference was 47.0% (95% Confidence Interval 31.2, 62.8), with a p-value of 0.0001.
- Regarding quality of life for genital psoriasis (Study-G), 60.0% of risankizumab-treated participants achieved a Dermatology Life Quality Index (DLQI) of 0 or 1, compared to 3.7% for placebo. The response rate difference was 56.5% (95% Confidence Interval 43.0, 70.0), with a p-value of 0.0001.
- For genital psoriasis itch (Study-G), 48.8% of risankizumab-treated participants achieved a clinically meaningful (≥ 4-point) improvement from baseline on the Genital Psoriasis Itch Numerical Rating Scale (NRS), compared to 6.7% for placebo. The response rate difference was 43.0% (95% Confidence Interval 26.6, 59.3), with a p-value of 0.0001.
- Impact on sexual frequency for genital psoriasis (Study-G) showed 71.0% of risankizumab-treated participants achieved a Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1, versus 21.9% for placebo. The response rate difference was 46.1% (95% Confidence Interval 26.7, 65.6), with a p-value of 0.0001.
What this means
The comprehensive positive results from this Phase 4 trial indicate that risankizumab is highly effective in treating moderate to severe genital and scalp psoriasis. The significant improvements observed across objective clinical assessments, quality of life measures, and symptom-specific scales like itch and sexual frequency, underscore its potential to substantially alleviate the burden of these specific forms of psoriasis. The consistent statistical significance (p=0.0001) across all key analyses further supports the robust efficacy of risankizumab in these challenging-to-treat areas.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05969223, titled "Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis," were posted on 2026-02-24 on clinicaltrials.gov.