Clinical trial NCT03817164: Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis
Official title: Multicenter, Randomized, Double-Blind, Sham-Controlled, Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plaque Psoriasis
Lead sponsor: Thync Global, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ethica Clinical Research Inc.
First posted: 2019-01-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: BSA x sPGA average percent change from Baseline
timeFrame: Week 16
Secondary outcomes:
measure: sPGA change from Baseline
timeFrame: Week 16
measure: BSA change from Baseline
timeFrame: Week 16
measure: Mean PASI change from Baseline
timeFrame: Week 16
measure: PASI 50
timeFrame: Week 16
measure: PASI 75
timeFrame: Week 16
measure: PSSI change from Baseline
timeFrame: Week 16
measure: QVAS change from Baseline
timeFrame: Week 16
measure: DLQI change from Baseline
timeFrame: Week 16
measure: PQOL-12 change from Baseline
timeFrame: Week 16
measure: HADS change from Baseline
timeFrame: Week 16
measure: Pruritus NRS change from Baseline
timeFrame: Week 16
measure: Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement)
timeFrame: Week 16
measure: TSQM
timeFrame: Week 16
Other outcomes:
measure: sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1)
timeFrame: Week 16
Locations:
city: Fremont
country: United States
facility: Site 1
state: California
Study officials:
References: