Trial results for the study "Brain Changes in Psoriasis After Secukinumab Treatment" (NCT04717466) investigating secukinumab in patients with psoriasis were posted on ClinicalTrials.gov on 2025-06-05. The study reported a mean change of 3 units in itch scores and 2 units in pain scores for the psoriasis group.
Background
The study aimed to assess the effect of a biologic drug targeting the Interleukin (IL)-17 pathway (secukinumab) on brain plasticity. It also sought to examine whether plastic changes correlate with the perception of well-being, itch, and pain in participants with psoriasis.
Trial design
The study (NCT04717466) was a Phase 4 trial that enrolled 20 participants. It investigated secukinumab in individuals with Psoriasis and included a Healthy control group. The trial's purpose was to assess the effect of secukinumab on brain plasticity and its correlation with patient-reported outcomes.
Key results
The trial results for the Psoriasis Group showed several changes from baseline:
- Change in Itch Score as Measured by the NRS: a mean change of 3 units on a scale (Standard Deviation: 0.130835626).
- Change in Pain Score as Measured by the NRS: a mean change of 2 units on a scale (Standard Error: 0.186739941).
- Change in PASI Scores: a mean change of 8 score on a scale (Standard Deviation: 8.206099453).
- Change in Participant Well-being as Measured by WHO-5: a mean change of 2 units on a scale (Standard Deviation: 0.59336165).
- Change in Physical Activity as Measured by 7D-PAR: a mean change of 7 score on a scale (Standard Deviation: 9.892384903).
Other measurements included:
- Change in Gray Matter Density: 0 voxel (Standard Deviation: 0) for the Psoriasis Group, and 0 voxel (Standard Deviation: 0.000927413) for the Healthy Group.
- Change in Brain Activity: 1 ml/100g/min (Standard Deviation: 55.79089921) for the Psoriasis Group, and -18 ml/100g/min (Standard Deviation: 87.98956788) for the Healthy Group.
- Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores: 0 score on a scale (Standard Deviation: 0.5) for the Psoriasis Group, and 2 score on a scale (Standard Deviation: 1.7) for the Healthy Group.
- Change in Participant Well-being as Measured by WHO-5 for the Healthy Group: 0 units on a scale (Standard Deviation: 0.382739698).
What this means
The results indicate that secukinumab treatment in psoriasis patients was associated with changes in subjective measures such as itch, pain, PASI scores, well-being, and physical activity. For the psoriasis group, mean changes were observed, including a 3-unit change in itch score, a 2-unit change in pain score, and an 8-unit change in PASI score. The study also explored brain changes, but the reported mean values for gray matter density and brain activity for both groups show minimal or no change, or large standard deviations, making their interpretation less clear without further context or statistical analysis. These findings provide data on the effects of secukinumab on various patient-reported outcomes and neurological parameters in psoriasis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04717466, titled "Brain Changes in Psoriasis After Secukinumab Treatment," were posted on 2025-06-05 on clinicaltrials.gov.