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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. (MATCH)

Primary Purpose

Plaque Psoriasis

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mind.Px Report

About this trial

This is an interventional diagnostic trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 plaque psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter (study-lesion).
Subjects must be treated with an anti-IL-17, anti-IL-23, or an anti TNF-α biologic
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).
Subjects must abstain from the use of steroid or any topical treatment to the identified study lesion from screening till the last study visit.
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.
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:

Subject is unable or unwilling to give written informed consent and/or to comply with study procedures.
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).
Subjects currently treated with Hydroxychloroquine (Plaquenil).
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.
More than 2 prior treatments with a biologic therapy.
Subjects with a BMI ≥40 and a diagnosis of Class III (Severe) Obesity (or solely a diagnosis of Class III (Severe) Obesity).
Any change in biologic medication (including change in dosage) between screening and randomization.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MND

TAU

Arm Description

Subject's physician in this group will be using the Mind.Px report as a treatment reference for prescribing the subject's biologic.

Treatment as usual. This group will have the biologic prescribed with results given to the physician at the end of the subject's participation and will not be used as a reference for the subject's treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05036889

First Posted

August 17, 2021

Last Updated

September 13, 2021

Sponsor

Mindera Health

1. Study Identification

Unique Protocol Identification Number

NCT05036889

Brief 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.

Acronym

MATCH

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

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 24, 2021 (Anticipated)

Primary Completion Date

July 1, 2022 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mindera Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MND

Arm Type

Experimental

Arm Description

Subject's physician in this group will be using the Mind.Px report as a treatment reference for prescribing the subject's biologic.

Arm Title

TAU

Arm Type

No Intervention

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Mind.Px Report

Intervention Description

Use of Mind.Px report as a reference for potential better matching of biologics to patients.

Primary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 plaque psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter (study-lesion). Subjects must be treated with an anti-IL-17, anti-IL-23, or an anti TNF-α biologic 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). Subjects must abstain from the use of steroid or any topical treatment to the identified study lesion from screening till the last study visit. 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. 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: Subject is unable or unwilling to give written informed consent and/or to comply with study procedures. 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). Subjects currently treated with Hydroxychloroquine (Plaquenil). 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. More than 2 prior treatments with a biologic therapy. Subjects with a BMI ≥40 and a diagnosis of Class III (Severe) Obesity (or solely a diagnosis of Class III (Severe) Obesity). Any change in biologic medication (including change in dosage) between screening and randomization. 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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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.

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