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

NCT03817164 | Unknown

• 1 other identifier: THY-004
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• BSA x sPGA average percent change from Baseline

  Body Surface Area x Static Physician Global Assessment

  Week 16

Secondary Outcomes (13)

• sPGA change from Baseline

  Week 16

• BSA change from Baseline

  Week 16

• Mean PASI change from Baseline

  Week 16

• PASI 50

  Week 16

• PASI 75

  Week 16

Other Outcomes (1)

• sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1)

  Week 16

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

Active stimulation pulsed current delivered over 15 minutes.

Device: Autonomic Nerve Modulation - Active

Control Treatment

SHAM COMPARATOR

Active stimulation pulsed current (alternative frequency) delivered over 15 minutes.

Device: Autonomic Nerve Modulation - Control

Interventions

Autonomic Nerve Modulation - Active DEVICE

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.

Active Treatment

Autonomic Nerve Modulation - Control DEVICE

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.

Control Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thync Global, Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (1)

Site 1

Fremont, California, 94538, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 25, 2019
• Study Start: October 2, 2018
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)