Trial results for a Phase 2 study (NCT05283135) investigating higher doses of risankizumab for psoriasis were posted on ClinicalTrials.gov on 2025-10-24. The study explored the effects of risankizumab on resident memory T cells and skin clearance in patients with plaque psoriasis. At Week 52, the 600 mg dose group showed a reduction in mean CD8+ Trm1 cells from 9.60 to 1.60 and CD8+ Trm17 cells from 19.67 to 3.20.
Background
Risankizumab (Skyrizi) is an intervention being explored for the treatment of psoriasis. This particular pilot study aimed to investigate the effects of higher than standard doses of risankizumab on resident memory T cells and skin clearance in patients with plaque psoriasis.
Trial design
The study (NCT05283135) was a Phase 2, completed pilot study that enrolled 20 participants with psoriasis. The trial investigated the effects of risankizumab at different higher-than-standard doses. Participants were assigned to either a 300 mg dose group or a 600 mg dose group to observe effects on resident memory T cells and skin clearance.
Key results
The trial investigated changes in resident memory T cells and skin clearance over 52 weeks. For the outcome of "CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52":
- In the 600 mg dose group, the mean number of CD8+ Trm1 cells was 9.60 cells at baseline and 1.60 cells at Week 52.
- In the 300 mg dose group, the mean number of CD8+ Trm1 cells was 26.71 cells at baseline and 16.63 cells at Week 52.
For the outcome of "CD8+ Trm17 Cells in Lesional Skin at Baseline and Week 52":
- In the 600 mg dose group, the mean number of CD8+ Trm17 cells was 19.67 cells at baseline and 3.20 cells at Week 52.
- In the 300 mg dose group, the mean number of CD8+ Trm17 cells was 22.88 cells at baseline and 5.00 cells at Week 52.
Regarding "PASI 100 Results in Patients Receiving 4X Standard Induction Doses of Risankizumab vs. Those Receiving 2X Standard Induction Doses of Risankizumab":
- At baseline, there were 7 participants in the 600 mg dose group and 8 participants in the 300 mg dose group.
- At Week 52, there were 6 participants in the 600 mg dose group and 6 participants in the 300 mg dose group.
What this means
The results from this Phase 2 pilot study indicate that higher doses of risankizumab led to reductions in CD8+ Trm1 and Trm17 cells in the lesional skin of patients with psoriasis over 52 weeks. The 600 mg dose group demonstrated a greater numerical reduction in both types of T cells compared to the 300 mg dose group. While the study also reported PASI 100 results, the primary focus of the reported outcomes appears to be the cellular changes, suggesting a biological effect of higher dose risankizumab on immune cells implicated in psoriasis pathogenesis. These findings contribute to understanding the potential impact of dose escalation for risankizumab in psoriasis treatment.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05283135, titled "High Dose Risankizumab for Psoriasis," were posted on 2025-10-24 on clinicaltrials.gov.