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

Not Applicable

• Conditions: Plaque Psoriasis
• Interventions: Device: Autonomic Nerve Modulation - Active; Device: Autonomic Nerve Modulation - Control

• Registration Number: NCT03817164
• Lead Sponsor: Thync Global, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-09
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	Autonomic Nerve Modulation - Active	Active stimulation pulsed current delivered over 15 minutes.
Control Treatment	Autonomic Nerve Modulation - Control	Active stimulation pulsed current (alternative frequency) delivered over 15 minutes.

Primary Outcome Measures

Name	Time	Method
BSA x sPGA average percent change from Baseline	Week 16	Body Surface Area x Static Physician Global Assessment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Site 1; 🇺🇸 Fremont, California, United States