Clinical trial NCT05036889: A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes.
Official title: A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plaque Psoriasis
Lead sponsor: Mindera Health
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This protocol describes randomized, multicenter, blinded (subjects), 16-week, controlled study in parallel balanced groups of psoriasis (Ps) patients to evaluate the impact of Mind.Px on response to biologic treatments. Patients enrolled in this study will be required to have diagnosis of Ps and a total score ≥10 on the PASI and the identified study-lesion must have a PGA severity ≥3 on a 5-point scale of 0 to 4.

Patients suffering from Ps will be enrolled in the study and randomized on a 1:1 basis to treatment as usual (TAU) or to treatment decision utilizing Mind.Px (MND). Both groups will have a dermal patch applied and analyzed. The TAU group will not be provided the results of the dermal patch until the end of the last study visit. The MND group will be provided the results of the dermal patch upon the completion of the analysis.


Eligibility criteria: 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 plaque psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter (study-lesion).
4. Subjects must be treated with an anti-IL-17, anti-IL-23, or an anti TNF-α biologic
5. Subject must abstain from the use of any treatment to the identified study-lesion after screening until the baseline visit (this includes biologic treatments until after the dermal patch sample has been collected).
6. Subjects must abstain from the use of steroid or any topical treatment to the identified study lesion from screening till the last study visit.
7. Subjects must have a baseline PASI ≥10 and the identified study-lesion must have a PGA severity ≥3 on a 5-point scale of 0 to 4.
8. Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.

Exclusion Criteria:

1. Subject is unable or unwilling to give written informed consent and/or to comply with study procedures.
2. Subject has had new usage of topical psoriasis treatments within 2 weeks prior to screening study visit (these concomitant immunomodulatory treatments such as corticosteroid/calcineurin inhibitors).
3. Subjects currently treated with Hydroxychloroquine (Plaquenil).
4. Subjects has had usage of anti TNF-α, IL-12/23, IL-17, IL-23, JAK inhibitor, or T-cell activation inhibitor, therapy within 2 weeks prior to baseline, unless otherwise approved by Sponsor.
5. More than 2 prior treatments with a biologic therapy.
6. Subjects with a BMI ≥40 and a diagnosis of Class III (Severe) Obesity (or solely a diagnosis of Class III (Severe) Obesity).
7. Any change in biologic medication (including change in dosage) between screening and randomization.
8. No phototherapy or other oral systemic therapy (acitretin, ciclosporin, methotrexate, apremilast, fumarate, oral JAK inhibitor, or T-cell activation inhibitor) at least 2 weeks before baseline and throughout study.

Primary outcomes:
measure: Evaluate the impact of Mind.Px on response to biologic treatment as judged by the mean change in the Psoriasis Area Severity index (PASI) score from baseline to end of Week 16 of the study.
timeFrame: 16 weeks
Secondary outcomes:
measure: Mean change in the Physician Global Assessment (PGA) by the Body Surface Area (BSA), or Dermatology Life Quality Index (DLQI) from baseline to end of Week 16 of the study
timeFrame: 16 weeks
Other outcomes:
Locations:
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