Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis

• Status: Active, not recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study determines the Maximum Tolerable Dose (MTD) by maximum BSA percentage treated and evaluates efficacy of various concentrations of 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 One Hundred Twenty (120) 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 different concentrations of AMTX-100 CF (low concentration (0.11% w/w), medium concentration (0.33% w/w) and high concentration (1.1% w/w)) or Vehicle (Placebo) in the study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amytrx Therapeutics, Inc.
• Collaborator: Amarex Clinical Research

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:

1. Male or female subjects who are 18 years or older

2. 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

3. All fertile female subjects as described above need to have a negative urine pregnancy test at the screening and baseline visits

4. 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

5. Subject is able to apply topical products on all treatable assigned areas by self and/or caregiver (if applicable), per the Investigator

6. Subject is in general good physical/mental health per the Investigator

7. Subject's Total Body Surface Area (BSA) is between 1.5 and 2.1 m2 per the Mosteller formula

8. 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

9. Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 2 or 3 (mild to moderate) at the screening and baseline visits

10. 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:

1. Cohort 1: 3% BSA ≤ AD Affected Area ≤ 6% BSA

2. Cohort 2: 6% BSA < AD Affected Area ≤ 12% BSA

3. Cohort 3: 12% BSA < AD Affected Area ≤ 24% BSA

4. Cohort 4: 24% BSA < AD Affected Area ≤ 48% BSA

5. Cohort 5: 48% BSA < AD Affected Area ≤ 70% BSA

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 one of the 2 methods below:

• "Handprint Method": the area represented by the palm with all five digits adducted together is approximately 1% of the subject's BSA

• "Rule of Nines": 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%])

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:

1. Pregnant or lactating females or women who are planning for pregnancy in the next 6 months

2. Women at postpartum for 3 months or less prior to screening

3. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator may interfere with the conduct of the study

4. Subjects with abnormal vital signs, physical and dermatological exams or clinical laboratory evaluations considered clinically significant by the Principal Investigator, which in the opinion of the PI would significantly interfere with the study conduct

5. Subjects with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator

6. The subject has a planned major surgical intervention for a pre-existing condition within the duration of the study

7. The subject has a history of drug or alcohol abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator.

8. Participation in a clinical trial within 3 months, or more than two clinical trials within 12 months prior to screening

9. Concurrent or recent use of topical steroids, topical immunosuppressive/immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) or salicylic acid within 14 days of the baseline visit

10. The subject has severe AD as determined by vIGA-AD™ score higher than 3

11. The subject cannot avoid systemic treatments (including systemic corticosteroids, immunotherapy, biologics or phototherapy) for AD during the study per the Investigator

12. The subject has previously received any systemic treatments, immunotherapy, biologics or phototherapy for AD within 12 months prior to study enrollment

13. Current or expected use of prohibited medications as described in Section 7, unless approved by the study Medical Monitor

14. The subject has concurrent contact dermatitis or history of anaphylactic reaction

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:

1. Male or female subjects who are 18 years or older.

2. 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.

3. All fertile female subjects as described above need to have a negative urine pregnancy test at the screening and baseline visits.

4. 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.

5. Subject is able to apply topical products on all the treatable areas by self and/or caregiver (if applicable), per the Investigator.

6. Subject is willing and able to comply with all clinic visits and study-related procedures.

7. Subject is able to understand and complete study-related questionnaires.

8. 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.

9. Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 2 or 3 (mild to moderate) at the screening and baseline visits.

10. Eczema Area and Severity Index (EASI) score lower than 23 at the screening and baseline visits

11. Subject has Atopic Dermatitis (AD) involvement of between 5% and 70% of the treatable BSA (excluding the scalp, face, eyes, eyelids, neck, 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, neck, hands, palms, feet, groin, genitals or the axillae) will be completed by one of the 2 methods below:

• "Handprint Method": the area represented by the palm with all five digits adducted together is approximately 1% of the subject's BSA

• "Rule of Nines": 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%])

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:

1. Pregnant or lactating females or women who are planning for pregnancy in the next 6 months

2. Women at postpartum for 3 months or less prior to screening

3. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator may interfere with the conduct of the study

4. Subjects with abnormal vital signs, physical and dermatological exams or clinical laboratory evaluations considered clinically significant by the Principal Investigator, which in the opinion of the PI would significantly interfere with the study conduct

5. Subjects with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator

6. The subject has a planned major surgical intervention for a pre-existing condition within the duration of the study

7. The subject has a history of drug or alcohol abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator.

8. Participation in a clinical trial within 3 months, or more than two clinical trials within 12 months prior to screening

9. Concurrent or recent use of prescription moisturizers, topical steroids, topical immunosuppressive/immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) or salicylic acid within 14 days of the baseline visit

10. The subject has severe AD as determined by vIGA-AD™ score higher than 3

11. The subject cannot avoid systemic treatments (including systemic corticosteroids, immunotherapy, biologics or phototherapy) for AD during the study per the Investigator

12. The subject has previously received any systemic treatments, immunotherapy, biologics or phototherapy for AD within 12 months prior to study enrollment

13. Current or expected use of prohibited medications and procedures during study treatment, as described in Section 7, unless approved by the study Medical Monitor

14. Subject has unstable AD or any consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms

15. Subject has a significant active systemic or localized infection, including known actively infected AD

16. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit

17. The subject has previously received AMTX-100 CF

18. Subject has any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion of the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments

19. The subject has concurrent contact dermatitis; or history of anaphylactic reaction