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STAMP-2: Subjects Through the Application of the Mindera Kit Part 2

Sponsor
Mindera Health (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04904315
Collaborator
(none)
100
Enrollment
9.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mindera Kit

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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).
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
May 30, 2022

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mindera Health

Investigators

  • Study Chair: Toby Dickerson, CSO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mindera Health
ClinicalTrials.gov Identifier:
NCT04904315
Other Study ID Numbers:
  • MND-20-PsCl-02
First Posted:
May 27, 2021
Last Update Posted:
May 27, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of May 27, 2021