NCT05036889

A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mindera Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol describes randomized, multicenter, blinded (subjects), 16-week, controlled study in parallel balanced groups of psoriasis (Ps) patients to evaluate the impact of Mind.Px on response to biologic treatments. Patients enrolled in this study will be required to have diagnosis of Ps and a total score ≥10 on the PASI and the identified study-lesion must have a PGA severity ≥3 on a 5-point scale of 0 to 4. Patients suffering from Ps will be enrolled in the study and randomized on a 1:1 basis to treatment as usual (TAU) or to treatment decision utilizing Mind.Px (MND). Both groups will have a dermal patch applied and analyzed. The TAU group will not be provided the results of the dermal patch until the end of the last study visit. The MND group will be provided the results of the dermal patch upon the completion of the analysis.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Mind.Px Report	Use of Mind.Px report as a reference for potential better matching of biologics to patients.

Timeline

• Start date: 2021-09-24
• Primary completion: 2022-07-01
• Completion: 2022-09-01
• First posted: 2021-09-08
• Last updated: 2021-09-16