Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis

Study Overview
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Brief Summary
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This is a 16-week, prospective, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate psoriasis treated with ANM. Psoriasis severity and stress levels will be measured at Weeks 0, 2, 8, 12, and 16.

Official Title
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Multicenter, Randomized, Double-Blind, Sham-Controlled, Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Device: Autonomic Nerve Modulation - Active
* Device: Autonomic Nerve Modulation - Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient, male or female of any race, 18 years of age or older. This study has no pregnancy restrictions. BSA* <10% (excluding palms, soles, intertriginous and inverse areas). sPGA* ≥3 (NOTE: sPGA score will be averaged across all lesions as opposed to grading target lesions). BSA x sPGA ≥12. Subject diagnosed with chronic plaque psoriasis at least 6 months prior to screening. Treatment-naïve of prohibited biological immunomodulating agents at the time of screening, or decided to stop treatment with the biologic before screening for the study. Be able to follow study instructions and likely to complete all required visits. Sign the IRB-approved ICF (which includes HIPAA). Exclusion Criteria: Non-plaque psoriasis (erythrodermic or pustular), guttate, inverse psoriatic arthritis, or drug-induced psoriasis. Subjects with plaque psoriasis on palms and soles at enrolment. Subjects with plaque psoriasis on the back of the neck that would interfere with device placement. Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis. Other than psoriasis, history of any clinically significant (as determined by Investigator) or other major uncontrolled disease. Psoriasis flare or rebound within 4 weeks of Visit 1 or spontaneously improving or rapidly deteriorating plaque psoriasis during that same time period, as determined by investigator. Use of prohibited medications within the following washout periods: Biological immunomodulating agents within the prior 12 weeks: etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), certolizumab pegol (Cimzia), ixekizumab (Taltz) Biological immunomodulating agents within the prior 24 weeks: ustekinumab (Stelara), secukinumab (Cosentyx), guselkumba (Tremfaya) Oral drugs within the prior 4 weeks: apremilast, methotrexate, cyclosporine, corticosteroids Oral drugs within the prior 12 weeks: acitretin Photochemotherapy (PUVA) within the prior 4 weeks Phototherapy (UVA/UVB) within the prior 2 weeks Topical treatment likely to impact signs and symptoms of psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, lactic acid, tar, urea, etc.) within the prior 2 weeks Prolonged sun exposure or use of tanning booths or other source of UV radiation. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the opinion of the PI, would make the subject inappropriate for entry into this study. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. Exposure to any other investigational drug/device within 30 days prior to study entry. Subjects with a pacemaker, or any type of metal implant in the neck (i.e., T5 and above).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Treatment<br>Active stimulation pulsed current delivered over 15 minutes. | Device: Autonomic Nerve Modulation - Active<br>* Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.<br>|
| Sham Comparator: Control Treatment<br>Active stimulation pulsed current (alternative frequency) delivered over 15 minutes. | Device: Autonomic Nerve Modulation - Control<br>* Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BSA x sPGA average percent change from Baseline | Body Surface Area x Static Physician Global Assessment | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sPGA change from Baseline | Static Physician Global Assessment | Week 16 | 
| BSA change from Baseline | Body Surface Area | Week 16 | 
| Mean PASI change from Baseline | Psoriasis Area and Severity Index | Week 16 | 
| PASI 50 | Psoriasis Area and Severity Index - 50% reduction | Week 16 | 
| PASI 75 | Psoriasis Area and Severity Index - 75% reduction | Week 16 | 
| PSSI change from Baseline | Psoriasis Scalp Severity Index | Week 16 | 
| QVAS change from Baseline | Stress Level Quantified Visual Analogue Scale | Week 16 | 
| DLQI change from Baseline | Dermatology Life Quality Index | Week 16 | 
| PQOL-12 change from Baseline | Psoriasis Quality of Life - 12 Item | Week 16 | 
| HADS change from Baseline | Hospital Anxiety and Depression Scale | Week 16 | 
| Pruritus NRS change from Baseline | Pruritus Numerical Rating Scale | Week 16 | 
| Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement) | Pruritus Numerical Rating Scale | Week 16 | 
| TSQM | Treatment Satisfaction Questionnaire for Medication | Week 16 |