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

A Two Part, Phase I/II, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of the Safety and Efficacy of Topically Applied AMTX-100 CF in Adult Patients With Mild to Moderate Atopic Dermatitis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04313400

Enrollment

Registered

2020-03-18

Start date

2020-03-10

Completion date

2024-01-02

Last updated

2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Brief summary

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.

Detailed 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).

Interventions

DRUG1.1% w/w AMTX-100 CF-part1

AMTX-100 CF, topical cream with 1.1% w/w active pharmaceutical ingredient

DRUGPlacebo

Topical cream manufactured to mimic AMTX-100 CF3

DRUG1.1% w/w AMTX-100 CF3-part2

AMTX-100 CF3, topical cream with 1.1% w/w active pharmaceutical ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Part 1 (Phase I) of the study is open-labeled. Part 2 (Phase II) of the study is double-blinded (Masking: Participant, Care Provider, Investigator, and Outcomes Assessor).

Intervention model description

Part 1 (Phase I): Part 1 of the study is an open-label, dose-escalation study to determine the MTD of AMTX-100 CF (1.1% w/w) for the highest treated percentage of the BSA affected with AD. Five (5) cohorts will be sequentially enrolled in the Part 1 of the study. Each cohort will include five (5) patients with eligible, treatable percentages of BSA affected with AD. Part 2 (Phase II): Part 2 of the study is a multi-center, double-blind, randomized, vehicle-controlled, dose-ranging study of the safety and efficacy of topically applied AMTX-100 CF3 in adult patients with Mild to Moderate AD. Sixty (60) patients will be enrolled in 2 groups of AMTX-100 CF3 along with a placebo (vehicle). The patients will be randomized in a 1:1 ratio with thirty (30) subjects in Group A: 1.1% of AMTX-100 CF3 and thirty (30) subjects will be randomized to Group B placebo (vehicle 0% w/w).

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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 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: 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. 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 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 \[1%\]) 12. 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

Design outcomes

Primary

Measure	Time frame	Description
Part 1 (Phase I) Primary: Maximum Tolerable Dose	Over the 7-day treatment period	Maximum Tolerable Dose (MTD) by maximum percentage of Body Surface Area (BSA) treated, by evaluation of dose-limiting toxicity (DLT) of AMTX-100 CF (1.1% w/w concentration) based on the safety profile
Part 2 (Phase II) Primary: Proportion of Responder Subjects at Day 28	Day 28	Proportion of responder subjects at Day 28, defined as subjects with both Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear) (on a 5-point scale) and a reduction of ≥ 2 points from baseline Note: Subjects who have received rescue treatments will be considered non-responders Note: We acknowledge that the percentage was reported, while the outcome measure indicates proportion. It was concluded that using percentage represents the results more apparent.

Secondary

Measure	Time frame	Description
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Days 7, 14, 21, 28 and 42	Baseline to Days 7, 14, 21, 28, and 42	The Eczema Area and Severity Index (EASI) is a validated measure to assess the severity and extent of AD (Hanifin et al., 2001). The EASI is a composite index with scores ranging from 0 to 72, where a higher score indicates increased extent and severity of atopic dermatitis.
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects at Days 7, 14, 21, 28, and 42 With Both vIGA-AD™ Score of 0 (Clear) or 1 (Almost Clear) on a 5-point Scale and a Reduction of ≥ 1 Point From Baseline	Days 7, 14, 21, and 28	The 5-point Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD™) is a validated measure of disease severity and success of atopic dermatitis treatments in clinical trials. The ratings (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe) are an overall assessment of AD skin lesions, based on the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Note: We acknowledge that the percentage is reported, while the outcome measure indicates proportion. It was concluded that using percentage represents the results more apparent.
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-75, Defined as Achieving at Least a 75% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42	Days 7, 14, 21, 28, and 42	The Eczema Area and Severity Index (EASI) is a validated measure to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, where a higher score indicates increased extent and severity of atopic dermatitis. Note: We acknowledge that the percentage is reported, while the outcome measure indicates proportion. It was concluded that using percentage represents the results more apparent.
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-50, Defined as Achieving at Least a 50% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42	Days 7, 14, 21, 28, and 42	The Eczema Area and Severity Index (EASI) is a validated measure to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, where a higher score indicates increased extent and severity of atopic dermatitis. Note: We acknowledge that the percentage is reported, while the outcome measure indicates proportion. It was concluded that using percentage represents the results more apparent.
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) at Days 7, 14, 21, 28, and 42	Baseline, Days 7, 14, 21, 28 and 42	The Pruritus Numeric Rating Scale (NRS) is a simple assessment tool that subjects used to report the intensity of their pruritus (itch) during a daily recall period. Subjects were asked the following questions: • For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours? Note: The weekly average of peak daily pruritus NRS was calculated by summing the daily scores for a week and dividing by the number of days with recorded scores, resulting in a range of 0 to 10.
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With Improvement (Reduction) of Weekly Average of Peak Daily Pruritus NRS ≥ 3 From Baseline at Day 28 and 42	Days 28 and 42	The Pruritus Numeric Rating Scale (NRS) is a simple assessment tool that subjects used to report the intensity of their pruritus (itch) during a daily recall period. Subjects were asked the following questions: • For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours? Note: The weekly average of peak daily pruritus NRS was calculated by summing the daily scores for a week and dividing by the number of days with recorded scores, resulting in a range of 0 to 10. Note: We acknowledge that the percentage is reported, while the outcome measure indicates proportion. It was concluded that using percentage represents the results more apparent.
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 28	Baseline, Day 28	The Dermatology Life Quality Index (DLQI) is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response (0 to 3 where 0 is not at all and 3 is very much) to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30. A high score is indicative of a poor QOL. For general inflammatory skin conditions, a change in DLQI score of at least 4 points is considered clinically important
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline of the Treated BSA With Active AD at Day 28, and 42	Baseline, Days 28, and 42	For Part 2, BSA affected by AD was assessed by the investigator per calculation of treatable % BSA by the Rule of Nines method: Values of 9% or 18% of surface area are assigned to specific regions in the adult (head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\])
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in vIGA-AD™ at Days 7, 14, 21, 28, and 42	Baseline to Days 7, 14, 21, 28, and 42	The 5-point Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD™) is a validated measure of disease severity and success of atopic dermatitis treatments in clinical trials. The ratings (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe) are an overall assessment of AD skin lesions, based on the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Other

Measure	Time frame	Description
Part 2 (Phase II) Safety Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs)	Baseline through follow-up (Day 42)	An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the subject to have occurred, or a worsening of a pre-existing condition. Treatment Emergent Adverse Events (TEAEs) were defined as adverse events with onset date on or after the first treatment.
Part 2 (Phase II) Safety Outcome Measures: Incidence of Withdrawals From the Study Due to TEAEs	Baseline through follow-up (Day 42)	An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the subject to have occurred, or a worsening of a pre-existing condition. Treatment Emergent Adverse Events (TEAEs) were defined as adverse events with onset date on or after the first treatment.
Part 1 (Phase I) Safety Outcome Measures: Incidence of Withdrawals From the Study Due to TEAEs	Baseline through follow-up (Day 21)	An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the subject to have occurred, or a worsening of a pre-existing condition. Treatment Emergent Adverse Events (TEAEs) were defined as adverse events with onset date on or after the first treatment.
Part 1 (Phase I) Safety Outcome Measures: Changes in Study Treatment Application Site Reaction Assessment	Baseline (post-dose), End of Treatment (Day 7), and Follow-up (Day 21)	Tolerability of topically applied AMTX-100 CF was evaluated based on investigator-assessed application site reactions assessment. Local skin reactions were assessed in all areas treated with AMTX-100 CF and graded by the investigator on a scale of 0 to 4 based on the area with the most severe skin reaction among all treated areas. A grade of 0 represented no reaction, and a grade of 4 indicated a marked and severe skin reaction that extended beyond the treated areas.
Part 1 (Phase I) Safety Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs)	Baseline through follow-up (Day 21)	An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the subject to have occurred, or a worsening of a pre-existing condition. Treatment Emergent Adverse Events (TEAEs) were defined as adverse events with onset date on or after the first treatment.
Part 1 (Phase I) Exploratory Outcome Measures: Percent Change From Baseline of the Treated BSA With Active AD at Day 7	Baseline, Day 7	For Part 1, Body surface area (BSA) affected by AD was assessed by the investigator per calculation of treatable % BSA by the handprint method: Handprint Method: the area represented by the palm with all five digits adducted together is approximately 1% of the subject's BSA
Part 1 (Phase I) Exploratory Outcome Measures: Change From Baseline in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) at Day 7	Baseline, Day 7	The 5-point Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD™) is a validated measure of disease severity and success of atopic dermatitis treatments in clinical trials. The ratings (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe) are an overall assessment of AD skin lesions, based on the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Part 1 Dose Escalation: Cohort 1 Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 3-6% of the BSA (3% BSA ≤ AD Affected Area ≤ 6% BSA)	5
Part 1 Dose Escalation: Cohort 2 Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 6-12% of the BSA (6% BSA \< AD Affected Area ≤ 12% BSA)	5
Part 1 Dose Escalation: Cohort 3 Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)	5
Part 1 Dose Escalation: Cohort 4 Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)	4
Part 1 Dose Escalation: Cohort 5 Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)	7
Part 2 Group A: 1.1% w/w AMTX-100 CF3 (1.1% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas	33
Part 2 Group B: Placebo Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas	32
Total	91

Withdrawals & dropouts

Period	Reason	FG005	FG006
Overall Study	Adverse Event	1	0
Overall Study	Lost to Follow-up	1	0
Overall Study	Withdrawal by Subject	4	1

Baseline characteristics

Characteristic	Total	Part 2 Group B: Placebo	Part 2 Group A: 1.1% w/w	Part 1 Dose Escalation: Cohort 1	Part 1 Dose Escalation: Cohort 2	Part 1 Dose Escalation: Cohort 5	Part 1 Dose Escalation: Cohort 4	Part 1 Dose Escalation: Cohort 3
Age, Continuous	47.35 years	46.0 years	46.1 years	51.6 years	41.4 years	49.4 years	62.8 years	40.6 years
BMI (kg/m2)	27.95 kilogram per meter squared	28.9 kilogram per meter squared	28.9 kilogram per meter squared	26.1 kilogram per meter squared	30.1 kilogram per meter squared	28.6 kilogram per meter squared	26.2 kilogram per meter squared	23.1 kilogram per meter squared
BSA (m2)	1.9 meter squared	2.0 meter squared	1.9 meter squared	1.8 meter squared	2.0 meter squared	1.9 meter squared	1.9 meter squared	1.7 meter squared
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants	13 Participants	10 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants	19 Participants	23 Participants	4 Participants	4 Participants	7 Participants	3 Participants	4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Height (cm)	167.95 centimeter	168.6 centimeter	167.5 centimeter	162.7 centimeter	171.9 centimeter	167.7 centimeter	169.3 centimeter	168.0 centimeter
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	12 Participants	4 Participants	7 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	30 Participants	5 Participants	10 Participants	2 Participants	4 Participants	5 Participants	2 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	43 Participants	20 Participants	13 Participants	3 Participants	1 Participants	1 Participants	2 Participants	3 Participants
Sex: Female, Male Female	49 Participants	17 Participants	20 Participants	4 Participants	1 Participants	4 Participants	1 Participants	2 Participants
Sex: Female, Male Male	42 Participants	15 Participants	13 Participants	1 Participants	4 Participants	3 Participants	3 Participants	3 Participants
Weight (kg)	78.85 Kilogram	82.3 Kilogram	81.2 Kilogram	69.0 Kilogram	88.9 Kilogram	80.2 Kilogram	75.4 Kilogram	64.5 Kilogram

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	0 / 5	0 / 5	0 / 5	0 / 4	0 / 7	0 / 33	0 / 32
other Total, other adverse events	1 / 5	3 / 5	2 / 5	0 / 4	2 / 7	5 / 33	3 / 32
serious Total, serious adverse events	0 / 5	0 / 5	0 / 5	0 / 4	0 / 7	0 / 33	0 / 32

Outcome results

Primary

Part 1 (Phase I) Primary: Maximum Tolerable Dose

Maximum Tolerable Dose (MTD) by maximum percentage of Body Surface Area (BSA) treated, by evaluation of dose-limiting toxicity (DLT) of AMTX-100 CF (1.1% w/w concentration) based on the safety profile

Time frame: Over the 7-day treatment period

Arm	Measure	Value (NUMBER)
Part 1 Dose Escalation: 3% to 70% of the BSA	Part 1 (Phase I) Primary: Maximum Tolerable Dose	29.2 Grams of IP per application

Primary

Part 2 (Phase II) Primary: Proportion of Responder Subjects at Day 28

Proportion of responder subjects at Day 28, defined as subjects with both Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear) (on a 5-point scale) and a reduction of ≥ 2 points from baseline Note: Subjects who have received rescue treatments will be considered non-responders Note: We acknowledge that the percentage was reported, while the outcome measure indicates proportion. It was concluded that using percentage represents the results more apparent.

Time frame: Day 28