Trial results for risankizumab (Skyrizi) in pediatric participants with moderate to severe plaque psoriasis were posted on ClinicalTrials.gov on 2025-05-20. The Phase 3 study demonstrated high rates of disease improvement, with participants achieving Psoriasis Area Severity Index (PASI) 75 rates up to 92.3% across various study parts.
Background
Psoriasis is a chronic, systemic, inflammatory disease characterized by the buildup of skin cells, leading to thick, red, and white scaly patches. There is an unmet medical need for effective treatments specifically for pediatric patients with moderate to severe plaque psoriasis.
Trial design
The study (NCT04435600) was a Phase 3 trial that enrolled 139 pediatric participants with moderate to severe plaque psoriasis. The study evaluated subcutaneous risankizumab injection, with ustekinumab included as a comparator in one period. The trial was designed in four parts to assess changes in disease symptoms.
Key results
The trial evaluated the percentage of participants achieving Psoriasis Area Severity Index (PASI) 75 and Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (score of 0 or 1).
- For the outcome "Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75":
- In Part 1: Risankizumab, 83.3% of participants achieved PASI 75.
- In Part 2 Period A: Ustekinumab, 85.7% of participants achieved PASI 75.
- In Part 2 Period A: Risankizumab, 85.2% of participants achieved PASI 75.
- In Part 3: Risankizumab, 92.3% of participants achieved PASI 75.
- In Part 4: Risankizumab, 86.7% of participants achieved PASI 75.
- For the outcome "Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)":
- In Part 1: Risankizumab, 83.3% of participants achieved sPGA 0 or 1.
- In Part 2 Period A: Ustekinumab, 75.0% of participants achieved sPGA 0 or 1.
- In Part 2 Period A: Risankizumab, 79.6% of participants achieved sPGA 0 or 1.
- In Part 3: Risankizumab, 84.6% of participants achieved sPGA 0 or 1.
- In Part 4: Risankizumab, 90.0% of participants achieved sPGA 0 or 1.
- For the outcome "Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline":
- In Part 1: Risankizumab, 83.3% of participants achieved this outcome.
- In Part 2 Period A: Ustekinumab, 67.9% of participants achieved this outcome.
What this means
The results from this Phase 3 study indicate that risankizumab demonstrated high efficacy in pediatric participants with moderate to severe plaque psoriasis. The consistently high percentages of participants achieving PASI 75 and sPGA 0 or 1 across different parts of the study suggest that risankizumab could be a valuable treatment option for this patient population, addressing an area of unmet medical need. The data from Part 2 Period A also provides a comparison with ustekinumab, showing similar levels of efficacy for risankizumab in achieving PASI 75 and sPGA 0 or 1.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04435600, titled "A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms," were posted on 2025-05-20 on clinicaltrials.gov.