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

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

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.

Study Overview

• Status: Unknown
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Device: Autonomic Nerve Modulation - Active; Device: Autonomic Nerve Modulation - Control

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Outpatient, male or female of any race, 18 years of age or older. This study has no pregnancy restrictions.
2. BSA* <10% (excluding palms, soles, intertriginous and inverse areas).
3. sPGA* ≥3 (NOTE: sPGA score will be averaged across all lesions as opposed to grading target lesions).
4. BSA x sPGA ≥12.
5. Subject diagnosed with chronic plaque psoriasis at least 6 months prior to screening.
6. 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.
7. Be able to follow study instructions and likely to complete all required visits.
8. Sign the IRB-approved ICF (which includes HIPAA).

Exclusion Criteria:

1. Non-plaque psoriasis (erythrodermic or pustular), guttate, inverse psoriatic arthritis, or drug-induced psoriasis.
2. Subjects with plaque psoriasis on palms and soles at enrolment.
3. Subjects with plaque psoriasis on the back of the neck that would interfere with device placement.
4. Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
5. Other than psoriasis, history of any clinically significant (as determined by Investigator) or other major uncontrolled disease.
6. 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.

7. 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
8. Prolonged sun exposure or use of tanning booths or other source of UV radiation.
9. 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.
10. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
11. Exposure to any other investigational drug/device within 30 days prior to study entry.
12. Subjects with a pacemaker, or any type of metal implant in the neck (i.e., T5 and above).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment; Active stimulation pulsed current delivered over 15 minutes.	Device: Autonomic Nerve Modulation - Active; 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.
Sham Comparator: Control Treatment; Active stimulation pulsed current (alternative frequency) delivered over 15 minutes.	Device: Autonomic Nerve Modulation - Control; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1)	Static Physician Global Assessment	Week 16

Collaborators and Investigators

• Sponsor: Thync Global, Inc.
• Collaborators: ethica Clinical Research Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): October 30, 2019

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: THY-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No