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).
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedMay 27, 2021
May 1, 2021
5 months
May 19, 2021
May 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
Male and female subjects who are 18 years of age or older with a diagnosis of psoriasis.
You may qualify if:
- Subject must have the ability to understand and sign written informed consent.
- Subject must be an adult male or female adult who is ≥ 18 years of age at the time of screening.
- Subject must be diagnosed with psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter.
- 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.
You may not qualify if:
- Subject is unable or unwilling to give written informed consent and/or to comply with study procedures.
- Subject has had usage of topical psoriasis treatments on study lesion within 2 weeks prior to baseline studyvisit and unwilling to washout.
- Subjects currently treated with Hydroxychloroquine (Plaquenil), unless otherwise approved by Sponsor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mindera Healthlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Toby Dickerson
CSO
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 27, 2021
Study Start
August 1, 2021
Primary Completion
January 1, 2022
Study Completion
May 30, 2022
Last Updated
May 27, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
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.