Subjects Through the Application of the Mindera Kit Part 2

Psoriasis Clinical Trial

— STAMP-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04904315
• Other study ID #: MND-20-PsCl-02
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: May 2021
• Source: Mindera
• Contact: Courtney Boyce
• Phone: 231-994-3848
• Email: cboyce[@]minderadx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 30, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a (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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• Mindera Kit
The entire duration of the study, including the screening period, will be approximately 16 weeks. Mindera Kit will be applied with applicator and left on the skin for 5 minutes, and once removed, the investigational product (IP) will be placed in a buffer solution, sealed, labeled and sent to Mindera for processing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mindera

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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