Status and phase
Conditions
Treatments
About
This study determines the Maximum Tolerable Dose (MTD) by maximum BSA percentage treated and evaluates safety and efficacy of 1.1% w/w AMTX-100 CF versus placebo (vehicle).
The study has two parts:
Phase I (Part 1):
Approximately Twenty five (25) subjects with various treatable Body Surface Area (BSA) involvement of Mild to Moderate Atopic Dermatitis will be enrolled in the study and treated with 1.1% w/w AMTX-100 CF.
Phase II (Part 2):
Approximately sixty (60) subjects with Mild to Moderate Atopic Dermatitis with various treatable BSA involvement of Mild to Moderate Atopic Dermatitis will be randomized to be treated with 1.1% w/w AMTX-100 CF3 concentration or Vehicle (Placebo) in the study.
Full description
AMTX-100 CF3 drug product is formulated as a water-based, topical cream incorporating a 28-amino acid synthetic polypeptide (AMTX-100) as the active pharmaceutical ingredient (API). AMTX-100 is a chimeric, cell-penetrating, bifunctional nuclear transport modifier (NTM), that is engineered to modulate nuclear transport of transcription factors (NF-κB, NFAT, AP-1, and STAT1) involved in the activation of gene expression of key mediators of inflammation (TNFα, IL-1β, IL-6, IL-17, MCP-1, etc.) and metabolic syndrome (ChREBP and SREBP) by importin α/β complex and importin β, respectively. This further leads to a reduction in pro-inflammatory cytokine/chemokine production and lipid and carbohydrate metabolic products.
AMTX-100 CF3 is intended to improve symptoms associated with mild to moderate Atopic Dermatitis in adults. This Phase I/II study aims to determine the Maximum Tolerable Dose (MTD) by maximum BSA percentage treated and to evaluate efficacy of 1.1% w/w AMTX-100 CF3 versus placebo (vehicle).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Part 1 Inclusion Criteria:
Subjects are required to meet ALL of the following criteria for enrollment into the Phase I (Part 1) of the study:
Male or female subjects who are 18 years or older
If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL
All fertile female subjects as described above need to have a negative urine pregnancy test at the screening and baseline visits
Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements
Subject is able to apply topical products on all treatable assigned areas by self and/or caregiver (if applicable), per the Investigator
Subject is in general good physical/mental health per the Investigator
Subject's Total Body Surface Area (BSA) is between 1.5 and 2.1 m2 per the Mosteller formula
The subject has physician confirmed mild to moderate Atopic Dermatitis (AD) defined by the Eichenfield revised criteria of Hannifin and Rajka, for at least 6 months prior to study enrollment
Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 2 or 3 (mild to moderate) at the screening and baseline visits
Subject has Atopic Dermatitis (AD) involvement with eligible treatable percent of the BSA appropriate for topical treatment per the assigned cohort at the screening and baseline visits per below:
Note: Calculation of Treatable BSA percentage (% of the total BSA that is AD-involved, excluding the scalp, face, eyes, eyelids, neck, hands, palms, feet, groin, genitals or axillae) will be completed by the method below:
o "Handprint Method": the area represented by the palm with all five digits adducted together is approximately 1% of the subject's BSA
Part 1 Exclusion Criteria:
Subjects are required to meet NONE of the following criteria for enrollment into the Phase I (Part 1) of the study:
Part 2 Inclusion Criteria:
Subjects are required to meet ALL of the following criteria for randomization into the Phase II (Part 2) of the study:
Male or female subjects who are 18 years or older.
If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy.
All fertile female subjects as described above need to have a negative urine pregnancy test at the screening and baseline visits.
Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements.
Subject is able to apply topical products on all the treatable areas by self and/or caregiver (if applicable), per the Investigator.
Subject is willing and able to comply with all clinic visits and study-related procedures.
Subject is able to understand and complete study-related questionnaires.
The subject has physician confirmed mild to moderate Atopic Dermatitis (AD) defined by the Eichenfield revised criteria of Hannifin and Rajka, for at least 6 months prior to study enrollment.
Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 2 or 3 (mild to moderate) at the screening and baseline visits.
Eczema Area and Severity Index (EASI) score lower than 23 at the screening and baseline visits
Subject has Atopic Dermatitis (AD) involvement of between 5% and 30% of the treatable BSA (excluding the scalp, face, eyes, eyelids, hands, palms, feet, groin, genitals or the axillae) appropriate for topical treatment at the screening and baseline visits.
Note: Calculation of Treatable BSA percentage (% of the total BSA that is AD-involved, excluding the scalp, face, eyes, eyelids, hands, palms, feet, groin, genitals or the axillae) will be completed by the "Rule of Nines" method:
o Where values of 9% or 18% of BSA are assigned to specific regions in the adult subject (head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%])
Subjects must be applying stable doses of an additive-free, basic bland emollient twice-daily for at least 1 week immediately before the baseline visit (Visit 2, Day 0), and to be continued throughout the study.
Note: The additive-free, basic bland emollients should be applied no earlier than 1 hour before or after the administration of the study treatment.
Part 2 Exclusion Criteria:
Subjects are required to meet NONE of the following criteria for randomization into the Phase II (Part 2) of the study:
Primary purpose
Allocation
Interventional model
Masking
91 participants in 3 patient groups, including a placebo group
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Central trial contact
Yashar Salek, MD, MSc
Data sourced from clinicaltrials.gov
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