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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03817164
• Other study ID #: THY-004
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: July 2019
• Source: Thync Global, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Site 1	Fremont	California

Sponsors (2)

Lead Sponsor	Collaborator
Thync Global, Inc.	ethica Clinical Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1)	Static Physician Global Assessment	Week 16
Primary	BSA x sPGA average percent change from Baseline	Body Surface Area x Static Physician Global Assessment	Week 16
Secondary	sPGA change from Baseline	Static Physician Global Assessment	Week 16
Secondary	BSA change from Baseline	Body Surface Area	Week 16
Secondary	Mean PASI change from Baseline	Psoriasis Area and Severity Index	Week 16
Secondary	PASI 50	Psoriasis Area and Severity Index - 50% reduction	Week 16
Secondary	PASI 75	Psoriasis Area and Severity Index - 75% reduction	Week 16
Secondary	PSSI change from Baseline	Psoriasis Scalp Severity Index	Week 16
Secondary	QVAS change from Baseline	Stress Level Quantified Visual Analogue Scale	Week 16
Secondary	DLQI change from Baseline	Dermatology Life Quality Index	Week 16
Secondary	PQOL-12 change from Baseline	Psoriasis Quality of Life - 12 Item	Week 16
Secondary	HADS change from Baseline	Hospital Anxiety and Depression Scale	Week 16
Secondary	Pruritus NRS change from Baseline	Pruritus Numerical Rating Scale	Week 16
Secondary	Pruritus NRS responder rate (i.e., proportion of subjects achieving a =4-point improvement)	Pruritus Numerical Rating Scale	Week 16
Secondary	TSQM	Treatment Satisfaction Questionnaire for Medication	Week 16