Atopic DermatitisPhase 1/2NCT04927572
Safety, Pharmacokinetics and Efficacy of FMX114 Versus Vehicle in Adults With Atopic Dermatitis
A Phase 1/2 study testing FMX114 in people with Atopic Dermatitis, run by Vyne Therapeutics Inc. at 7 sites in 2 countries.
Trial summary
A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial with Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- FMX114
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 13 Oct 2021to 9 Aug 2022
- Phase
- Phase 1/2
- 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
- Subjects must have the ability to understand and be willing to sign an informed consent form.
- Aged ≥ 18 years, at time of screening visit.
- Weight ≥ 40 kg, at time of screening visit.
- Diagnosis of Atopic Dermatitix with a total body surface area (BSA) of AD involvement of ≤ 35% excluding involvement of face, scalp and groin at screening and Day 1, prior to first dose.
- Atopic dermatitis should be present for at least 3 months with stable disease for ≥ 1 month at the time of the screening visit and on Day 1, prior to dose administration.
- Have the presence of at least 2 comparable target AD lesions (size approximately 10 to 200 cm2), located on the trunk, upper extremities or lower extremities. In addition, the 2 target lesions:
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- must have ADSI score of ≥ 6 and ≤ 12 AND a between-lesion difference in ADSI of ≤ 1.
- must be separated by ≥ 10 cm.
- Positive varicella zoster virus (VZV) antibody test at the screening visit. At the discretion of the Investigator, subjects who return a negative result may be re-screened following a full VZV vaccination course.
- Medically healthy in the opinion of the Investigator without significant abnormalities at the screening visit and prior to dose administration on Day 1, including:
- Physical examination without any clinically relevant findings (excluding findings relating to AD).
- Systolic blood pressure in the range of 90 to 160 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position.
- Heart rate in the range of 45 to 100 bpm (inclusive) after 5 minutes rest in supine.
- Body temperature (tympanic or oral), between 35.5°C and 37.7°C (inclusive).
- Electrocardiogram findings (ventricular HR, PR interval, QRS duration, QT interval and QTcF) within normal ranges (site-specific normal ranges may be used).
- Triplicate 12-lead electrocardiogram (ECG) (taken after the subject has been supine for at least 5 minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no other clinically significant abnormalities.
- All laboratory blood and urinalysis test results within normal ranges for the local laboratory, including the following specific findings:
- Lymphocyte count ≥ 0.5 x 10 9/L ii. Haemoglobin ≥ 9g/dL iii. Absolute neutrophil count ≥ 1 x 10 9/L Assessments may be repeated once, if abnormal values were recorded in the first instance, at the discretion of the PI.
- Female subjects must:
- Be of non-childbearing potential (i.e., surgically sterilised [hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit]) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone [FSH] level >40 IU/L at the screening visit), or
- If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception (refer to Section 21.5) from signing the consent form until at least 2 months after the last dose of the study drug.
- Male subjects, if not biologically or surgically sterilized, must agree not to donate sperm and, if engaging in sexual intercourse, must agree to use a condom from signing the consent form until at least 90 days after the last dose of study drug. If engaging with a female partner who could become pregnant, the female partner must additionally use an acceptable method of contraception (refer to Section 21.5) for this same period.
- Have suitable venous access for blood sampling.
- Be willing and able to comply with all study assessments (optional photography assessments excluded) and adhere to the protocol schedule and restrictions
Who cannot join
- In the opinion of the Investigator, subject has unstable or actively infected AD at the screening visit, or prior to dose administration on Day 1.
- Active impetigo at any of the target lesions.
- Concomitant dermatologic conditions (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may, in the opinion of the Investigator, interfere with evaluations of the subject's response to study drug.
- Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- Evidence or history of active, latent or inadequately treated tuberculosis (TB) infection at the screening visit.
- Evidence or history of disseminated or recurrent herpes zoster infection.
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- Clinically significant active infection (in the opinion of the Investigator) within 2 weeks prior to first dose application on Day 1.
- Any known or suspected premalignant or malignant disease within the last 5 years (excluding successfully treated basal cell carcinomas).
- Have received AD-directed therapy within the following timeframes prior to dose administration on Day 1:
- Ultraviolet A (UVA) or Ultraviolet B (UVB) therapy within 2 weeks.
- Systemic or topical corticosteroids within the past 2 weeks.
- Other topical anti-inflammatory therapy e.g. Janus kinase (JAK) inhibitors, calcineurin inhibitors, Phosphodiesterase-4 inhibitors within the past 2 weeks.
- Systemic JAK inhibitors within the past 12 weeks.
- Systemic biologic therapy within the past 12 weeks.
- Bleach or other antiseptic baths (e.g., potassium permanganate) within the past 2 weeks.
- Any other active topical therapy on target lesions within 7 days (does not include non-medicated moisturisers, sunscreens, lotions or creams).
- Use of any topical product (e.g. sunscreen, lotions, creams) on the target lesion within 24 hours prior to dose administration on Day 1.
- Live and live attenuated vaccines are not permitted within 30 days prior to the first application of study drug, and for 2 months following the last dose application. It is noted that mRNA or adeno-associated virus (AAV)-based COVID-19 vaccinations are permitted at any stage throughout the study.
- Use of any systemically absorbed prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration Exceptions may be made for medications which, in the opinion of the Investigator, are unlikely to affect the course of the AD during the study period (for example stable use of antihistamines for asthma or allergies. Antibiotics, if not known to impact AD disease course, may also be allowed at the discretion of the PI in consultation with the medical monitor).
- Participation in another investigational clinical trial within 30 days (or 5 half-lives, of the investigational agent) (whichever is longer) prior to the first study drug administration.
- Presence or evidence of recent sunburn, scar tissue, tattoo (more than 25% of body area), open sore, or branding that, in the opinion of the Investigator, would interfere with evaluations of the subject's response to study drug.
- Known hypersensitivity to any component of the study drug.
- Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the subject's ability to participate in the trial.
- Known or suspected history of alcohol or drug abuse (in the opinion of the Investigator) within the last 2 years.
- Documented history of depression or self-harm that is not, in the opinion of the Investigator, currently adequately controlled with medication or in remission.
- Positive drug or alcohol test results at the screening visit or on Day 1, prior to dose administration (may be repeated once, if a positive test was recorded in the first instance, at the discretion of the Investigator).
- Consumption of grapefruit or Seville orange (or products containing grapefruit or Seville orange) within 72 hours prior to the first FMX114 dose administration on Day 1 (consumption is also not permitted throughout the duration of the study).
- Any other condition or prior therapy that in the opinion of the Investigator would make the subject unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Investigator #9
Miami, Florida, 33173
Investigator #14
Miami, Florida, 33175
Investigator #12
Miramar, Florida, 33027
Investigator #13
Sugarloaf, Pennsylvania, 18249
Australia3 sites
Investigational Site #1
Adelaide, South Australia, 5000
Investigator #6
Darlinghurst, New South Wales, 2010
Investigator #5
Phillip, Australian Capital Territory, 2606
About this study
Official title: A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial With Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults
A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial with Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults
- Conditions
- Atopic Dermatitis
- Being tested
- FMX114, Vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMX114Drug
Active Comparator
VehicleOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| FMX114 | Experimental | Not described Receives: Drug: FMX114 |
| Vehicle | Placebo comparator | Not described Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Atopic Dermatitis Severity Index (ADSI) score at Day 29
Measured: Day 29
Incidence, type and severity of adverse events (AEs) at Day 43
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start13 Oct 2021
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927572
- Sponsor's protocol ID
- VY2021-01
- Status last verified
- Aug 2022
- First submitted
- 2 Jun 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial With Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults
- ClinicalTrials.gov ID
- NCT04927572
- Acronym / sponsor ID
- VY2021-01
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 16 Jun 2021 (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.
A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial with Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMX114 | Experimental | Drug: FMX114 |
| Vehicle | Placebo comparator | Other: Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subjects must have the ability to understand and be willing to sign an informed consent form.
- Aged ≥ 18 years, at time of screening visit.
- Weight ≥ 40 kg, at time of screening visit.
- Diagnosis of Atopic Dermatitix with a total body surface area (BSA) of AD involvement of ≤ 35% excluding involvement of face, scalp and groin at screening and Day 1, prior to first dose.
- Atopic dermatitis should be present for at least 3 months with stable disease for ≥ 1 month at the time of the screening visit and on Day 1, prior to dose administration.
Key exclusion criteria (28 listed)
- In the opinion of the Investigator, subject has unstable or actively infected AD at the screening visit, or prior to dose administration on Day 1.
- Active impetigo at any of the target lesions.
- Concomitant dermatologic conditions (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may, in the opinion of the Investigator, interfere with evaluations of the subject's response to study drug.
- Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- Evidence or history of active, latent or inadequately treated tuberculosis (TB) infection at the screening visit.
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 |
|---|---|---|
| FMX114Active Comparator | Drug | FMX114 |
| VehiclePlacebo Comparator | Other | Vehicle |
Primary outcome
Mean Change from Baseline in Atopic Dermatitis Severity Index (ADSI) score at Day 29
Time frame: Day 29
Incidence, type and severity of adverse events (AEs) at Day 43
Time frame: Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- 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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FMX114 in people with Atopic Dermatitis, run by Vyne Therapeutics Inc. at 7 sites in 2 countries.
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 24 inclusion and 28 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: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Change from Baseline in Atopic Dermatitis Severity Index (ADSI) score at Day 29 (time frame: Day 29). The study lists 2 primary outcomes in all. 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 31 Aug 2022.