Plaque PsoriasisNCT03817164
Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis
A study testing Autonomic Nerve Modulation - Active in people with Plaque Psoriasis, run by Thync Global, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Autonomic Nerve Modulation - Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- 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.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- Exposure to any other investigational drug/device within 30 days prior to study entry.
- Subjects with a pacemaker, or any type of metal implant in the neck (i.e., T5 and above).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Plaque Psoriasis
- Being tested
- Autonomic Nerve Modulation - Active, Autonomic Nerve Modulation - Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic Nerve Modulation - ActiveDevice
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 - ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Active stimulation pulsed current delivered over 15 minutes. Receives: Device: Autonomic Nerve Modulation - Active |
| Control Treatment | Sham comparator | Active stimulation pulsed current (alternative frequency) delivered over 15 minutes. Receives: Device: Autonomic Nerve Modulation - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSA x sPGA average percent change from Baseline
Body Surface Area x Static Physician Global Assessment
Measured: Week 16
Secondary outcomes (13)
sPGA change from Baseline
Static Physician Global Assessment
Measured: Week 16
BSA change from Baseline
Body Surface Area
Measured: Week 16
Mean PASI change from Baseline
Psoriasis Area and Severity Index
Measured: Week 16
PASI 50
Psoriasis Area and Severity Index - 50% reduction
Measured: Week 16
PASI 75
Psoriasis Area and Severity Index - 75% reduction
Measured: Week 16
PSSI change from Baseline
Psoriasis Scalp Severity Index
Measured: Week 16
QVAS change from Baseline
Stress Level Quantified Visual Analogue Scale
Measured: Week 16
DLQI change from Baseline
Dermatology Life Quality Index
Measured: Week 16
PQOL-12 change from Baseline
Psoriasis Quality of Life - 12 Item
Measured: Week 16
HADS change from Baseline
Hospital Anxiety and Depression Scale
Measured: Week 16
Pruritus NRS change from Baseline
Pruritus Numerical Rating Scale
Measured: Week 16
Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement)
Pruritus Numerical Rating Scale
Measured: Week 16
TSQM
Treatment Satisfaction Questionnaire for Medication
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start2 Oct 2018
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thync Global, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817164
- Sponsor's protocol ID
- THY-004
- Status last verified
- Jul 2019
- First submitted
- 23 Jan 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Sham-Controlled, Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03817164
- Acronym / sponsor ID
- THY-004
- Conditions
- Plaque Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Thync Global, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: Autonomic Nerve Modulation - ActiveActive stimulation pulsed current delivered over 15 minutes. |
| Control Treatment | Sham comparator | Device: Autonomic Nerve Modulation - ControlActive stimulation pulsed current (alternative frequency) delivered over 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomic Nerve Modulation - ActiveThync 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. | Device | Active Treatment |
| Autonomic Nerve Modulation - ControlThync 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. | Device | Control Treatment |
Primary outcome
BSA x sPGA average percent change from Baseline
Time frame: Week 16
Body Surface Area x Static Physician Global Assessment
13 secondary outcomes
sPGA change from Baseline
Time frame: Week 16
BSA change from Baseline
Time frame: Week 16
Mean PASI change from Baseline
Time frame: Week 16
PASI 50
Time frame: Week 16
PASI 75
Time frame: Week 16
PSSI change from Baseline
Time frame: Week 16
QVAS change from Baseline
Time frame: Week 16
DLQI change from Baseline
Time frame: Week 16
PQOL-12 change from Baseline
Time frame: Week 16
HADS change from Baseline
Time frame: Week 16
Pruritus NRS change from Baseline
Time frame: Week 16
Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement)
Time frame: Week 16
TSQM
Time frame: Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autonomic Nerve Modulation - Active in people with Plaque Psoriasis, run by Thync Global, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSA x sPGA average percent change from Baseline (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.