Plaque PsoriasisMATCHNCT05036889
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.
A study testing Mind.Px Report in people with Plaque Psoriasis, run by Mindera Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Mind.Px Report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 24 Sep 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Plaque Psoriasis
- Being tested
- Mind.Px Report
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind.Px ReportDiagnostic test
Use of Mind.Px report as a reference for potential better matching of biologics to patients.
| Study group | Role | What they receive |
|---|---|---|
| MND | Experimental | Subject's physician in this group will be using the Mind.Px report as a treatment reference for prescribing the subject's biologic. Receives: Diagnostic Test: Mind.Px Report |
| TAU | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 16 weeks
Secondary outcomes (1)
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
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start24 Sep 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mindera Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036889
- Sponsor's protocol ID
- MND-21-MKPs-02
- Acronym
- MATCH
- Status last verified
- Sep 2021
- First submitted
- 17 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strober BE, Bukhalo M, Armstrong AW, Pariser D, Kircik L, Johnson B, Montgomery P 3rd, Dickerson TJ. Clinical Utility Findings of a Transcriptomic Psoriasis Biologic Test Demonstrate Altered Physician Prescribing Behavior and Improved Patient Outcomes. Dermatol Ther (Heidelb). 2025 Jul;15(7):1787-1796. doi: 10.1007/s13555-025-01441-y. Epub 2025 May 11.
PubMed 40349264
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05036889
- Acronym / sponsor ID
- MATCH / MND-21-MKPs-02
- Conditions
- Plaque Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mindera HealthIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MND | Experimental | Diagnostic Test: Mind.Px ReportSubject's physician in this group will be using the Mind.Px report as a treatment reference for prescribing the subject's biologic. |
| TAU | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind.Px ReportUse of Mind.Px report as a reference for potential better matching of biologics to patients. | Diagnostic test | MND |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 40349264Strober BE, Bukhalo M, Armstrong AW, Pariser D, Kircik L, Johnson B, Montgomery P 3rd, Dickerson TJ. Clinical Utility Findings of a Transcriptomic Psoriasis Biologic Test Demonstrate Altered Physician Prescribing Behavior and Improved Patient Outcomes. Dermatol Ther (Heidelb). 2025 Jul;15(7):1787-1796. doi: 10.1007/s13555-025-01441-y. Epub 2025 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mind.Px Report in people with Plaque Psoriasis, run by Mindera Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.