Psoriasis
Conditions
Brief 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.
Interventions
OTHERMindera 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.
Sponsors
Mindera Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observation of on therapy transcriptomics to potentially aid in new therapeutic targets | 16 weeks | 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. |
Contacts
Primary ContactCourtney Boyce
Backup ContactPaul Montgomery
Outcome results
None listed