Subjects Through the Application of the Mindera Kit Part 2 (STAMP-2)

An Exploratory, Multicenter, Observational Study to Examine RNA Biomarkers of Psoriasis Subjects Through the Application of the Mindera Kit Part 2 (STAMP-2).

A 16 week study to examine if baseline or on-therapy transcriptomics can be used to help predict selection of medications and provide new therapeutic targets for drug development in psoriasis subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Other: Mindera Kit

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Courtney Boyce; Phone Number: 231-994-3848; Email: cboyce@minderadx.com
• Study Contact Backup: Name: Paul Montgomery; Phone Number: 513-706-8614; Email: pmontgomery@minderadx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects who are 18 years of age or older with a diagnosis of psoriasis.

Description

Inclusion Criteria

1. Subject must have the ability to understand and sign written informed consent.
2. Subject must be an adult male or female adult who is ≥ 18 years of age at the time of screening.
3. Subject must be diagnosed with psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter.
4. Subjects must be treated with anti-TNF-α (or biosimilar) therapy once enrolled in the study.A two-week period is required to washout of the previous biologic when switching therapies.

Exclusion Criteria

1. Subject is unable or unwilling to give written informed consent and/or to comply with study procedures.
2. Subject has had usage of topical psoriasis treatments on study lesion within 2 weeks prior to baseline studyvisit and unwilling to washout.
3. Subjects currently treated with Hydroxychloroquine (Plaquenil), unless otherwise approved by Sponsor

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observation of on therapy transcriptomics to potentially aid in new therapeutic targets	To examine if baseline or on-therapy transcriptomics can be used to help predict selection of medications and provide new therapeutic targets for drug development in psoriasis subjects by collecting RNA and examining changes in PASI scores at the Week 4, 12, and 16 timepoints.	16 weeks

Collaborators and Investigators

• Sponsor: Mindera Health
• Investigators: Study Chair: Toby Dickerson, CSO

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: MND-20-PsCl-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: In order to protect patient privacy genetic data will not be shared outside of the study without further patient consent to do so. If other researchers would like access to the data they must reach out to the patients themselves.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No