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

NCT04313400 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AMTX100-AD-01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 11

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.

Conditions

Atopic Dermatitis

Keywords

AD

Outcome Measures

Primary Outcomes (2)

• 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

  Over the 7-day treatment period

• 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.

  Day 28

Secondary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (7)

• Part 1 (Phase I) Exploratory Outcome Measures: Percent Change From Baseline of the Treated BSA With Active AD at Day 7

  Baseline, Day 7

• 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

• Part 1 (Phase I) Safety Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Baseline through follow-up (Day 21)

Study Arms (3)

Part 1 Dose Escalation: 3% to 70% of the BSA

EXPERIMENTAL

Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)

Drug: 1.1% w/w AMTX-100 CF-part1

Part 2 Group A: 1.1% w/w

EXPERIMENTAL

AMTX-100 CF3 (1.1% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas

Drug: 1.1% w/w AMTX-100 CF3-part2

Part 2 Group B: Placebo

PLACEBO COMPARATOR

Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas

Drug: Placebo

Interventions

1.1% w/w AMTX-100 CF-part1 DRUG

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

Part 1 Dose Escalation: 3% to 70% of the BSA

Placebo DRUG

Topical cream manufactured to mimic AMTX-100 CF3

Also known as: placebo (vehicle 0% w/w)

Part 2 Group B: Placebo

1.1% w/w AMTX-100 CF3-part2 DRUG

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

Also known as: part2

Part 2 Group A: 1.1% w/w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Cohort 1: 3% BSA ≤ AD Affected Area ≤ 6% BSA
• Cohort 2: 6% BSA \< AD Affected Area ≤ 12% BSA
• Cohort 3: 12% BSA \< AD Affected Area ≤ 24% BSA
• Cohort 4: 24% BSA \< AD Affected Area ≤ 48% BSA

You may not qualify if:

• Subjects are required to meet NONE of the following criteria for enrollment into the Phase I (Part 1) of the study:
• Pregnant or lactating females or women who are planning for pregnancy in the next 6 months
• Women at postpartum for 3 months or less prior to screening
• 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
• 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
• Subjects with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator
• The subject has a planned major surgical intervention for a pre-existing condition within the duration of the study
• 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.
• Participation in a clinical trial within 3 months, or more than two clinical trials within 12 months prior to screening
• 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
• The subject has severe AD as determined by vIGA-AD™ score higher than 3
• The subject cannot avoid systemic treatments (including systemic corticosteroids, immunotherapy, biologics or phototherapy) for AD during the study per the Investigator
• The subject has previously received any systemic treatments, immunotherapy, biologics or phototherapy for AD within 12 months prior to study enrollment
• Current or expected use of prohibited medications as described in Section 7, unless approved by the study Medical Monitor
• The subject has concurrent contact dermatitis or history of anaphylactic reaction

Sponsors & Collaborators

• Amytrx Therapeutics, Inc.: lead
• Amarex Clinical Research: collaborator

Study Sites (11)

Amytrx Investigational site

Cerritos, California, 90703, United States

Location

Amytrx Investigational site

Encino, California, 91436, United States

Location

Amytrx Investigational site

Long Beach, California, 90805, United States

Location

Amytrx Investigational site

North Hollywood, California, 91606, United States

Location

Amytrx Investigational site

San Diego, California, 92123, United States

Location

Amytrx Investigational site

Sherman Oaks, California, 91403, United States

Location

Amytrx Investigational site

Miami, Florida, 33175, United States

Location

Amytrx Investigational site

Miramar, Florida, 33027, United States

Location

Amytrx Investigational site

Troy, Michigan, 48084, United States

Location

Amytrx Investigational site

New York, New York, 11415, United States

Location

Amytrx Investigational site

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (2)

• Liu Y, Qiao H, Zienkiewicz J, Hawiger J. Anti-inflammatory control of human skin keratinocytes by targeting nuclear transport checkpoint. Skin Health Dis. 2024 Mar 3;4(3):e356. doi: 10.1002/ski2.356. eCollection 2024 Jun.

  PMID: 38846687 DERIVED

• Liu Y, Zienkiewicz J, Qiao H, Gibson-Corley KN, Boyd KL, Veach RA, Hawiger J. Genomic control of inflammation in experimental atopic dermatitis. Sci Rep. 2022 Nov 7;12(1):18891. doi: 10.1038/s41598-022-23042-x.

  PMID: 36344555 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Ahmad Bayat, Sr Director II, Regulatory Affairs
• Organization: Amarex Clinical Research, LLC

ahmadb@amarexcro.com

301-956-2523

Study Officials

• Arezou Bayat, MD, MPH

  Amarex Clinical Research, LLC (Amarex)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: March 10, 2020
• Primary Completion: December 19, 2023
• Study Completion: January 2, 2024
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)