Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT04313400 |
Recruitment Status :
Completed
First Posted : March 18, 2020
Last Update Posted : January 18, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | March 16, 2020 | ||||
First Posted Date ICMJE | March 18, 2020 | ||||
Last Update Posted Date | January 18, 2024 | ||||
Actual Study Start Date ICMJE | March 10, 2020 | ||||
Actual Primary Completion Date | December 19, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis | ||||
Official Title ICMJE | 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 | ||||
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. |
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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). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment 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). 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). Primary Purpose: Treatment
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Condition ICMJE | Atopic Dermatitis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
91 | ||||
Original Estimated Enrollment ICMJE |
145 | ||||
Actual Study Completion Date ICMJE | January 2, 2024 | ||||
Actual Primary Completion Date | December 19, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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:
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:
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:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04313400 | ||||
Other Study ID Numbers ICMJE | AMTX100-AD-01 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Amytrx Therapeutics, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Amytrx Therapeutics, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Amarex Clinical Research | ||||
Investigators ICMJE |
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PRS Account | Amytrx Therapeutics, Inc. | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |