Brain Changes in Psoriasis After Secukinumab Treatment

Phase 4

Active, not recruiting

• Conditions: Psoriasis; Healthy
• Interventions: Biological: Secukinumab

• Registration Number: NCT04717466
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to assess the effect of a biologic drug targeting the Interleukin (IL)-17 pathway (secukinumab) on brain plasticity and examine whether the plastic changes correlate with the improvement of perception of well-being, itch, and pain in participants with psoriasis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-22
• Study Start: 2021-06-29
• Primary Completion: 2024-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psoriasis Group	Secukinumab	Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.

Primary Outcome Measures

Name	Time	Method
Change in gray matter density	Baseline, Up to Week 4 (Visit 3)	Changes in brain anatomy for psoriasis participants will be reported as the change in gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans
Change in brain activity	Baseline, Up to Week 4 (Visit 3)	Changes in brain activity in psoriasis participants will be measured using Arterial Spin Labeling (ASL) MRI

Secondary Outcome Measures

Name	Time	Method
Change in itch score as measured by the NRS	Baseline, Up to Week 4 (Visit 3)	Itch will be measured using the Numerical Rating Scaling (NRS) ranging from 0 (no itch) to 10 (the worst itch imaginable).
Change in physical activity as measured by 7D-PAR	Baseline, Up to Week 4 (Visit 3)	Physical activity will be measured using the 7-days physical activity recall (7D-PAR), ranging from 0 to 27, with a higher score indicating more physical activity.
Changes in stress in daily life as measured by PSQ	Baseline, Up to Week 4 (Visit 3)	Stress in daily life in psoriasis participants will be measured using the Perceived Stress Questionnaire (PSQ), ranging from 0 to 1, with a higher score indicating more stress.
Change in pain score as measured by the NRS	Baseline, Up to Week 4 (Visit 3)	Pain will be measured using a Numerical Rating Scaling (NRS) ranging from 0 (no pain) to 10 (the worst pain imaginable).
Change in PASI scores	Baseline, Up to Week 4 (Visit 3)	Severity of psoriasis will be measured using the Psoriasis Area and Severity Index (PASI), ranging from 0 to 100, with a higher score indicating more severe psoriasis.
Change in quality of sleep as measured by PSQI scores	Baseline, Up to Week 4 (Visit 3)	Quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 49, with a higher score indicating lower sleep quality.
Change in participant well-being as measured by WHO-5	Baseline, Up to Week 4 (Visit 3)	Well-being will be measured using the 5-item World Health Organization Well-Being Index (WHO-5), ranging from 0 to 25, with a higher score indicating better well-being.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States