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Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Primary Purpose

Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Dermatitis of Scalp

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HY209GEL Active
Placebo
Sponsored by
Shaperon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Male or female subjects aged 18 or older Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist at least 6 months ago from screening Subjects who have a minimum of 5% and a maximum of 30% of total body surface area (BSA) affected by AD at screening and baseline visits Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit Subjects who can give written informed consent Key Exclusion Criteria: Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) or any consistent requirement for any potency topical corticosteroids Subjects who have topical treatment with corticosteroids within 2 weeks prior to baseline visit or other topical treatments of the AD area at screening (moisturizers/emollients are allowed) Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatments within 4 weeks prior to baseline visit Subjects who had dupilumab or any other biologics within 6 months prior to baseline visit Subjects who take any systemic anti-infective or antibiotic treatments within 1 week prior to baseline visit Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks prior to screening Subjects who have active malignancy or history of cancer in 5 years prior to screening, except for treated cautions basal cell carcinoma and in situ cervical cancer Subjects who have any other skin diseases that would affect the ability to assess the AD Subjects who are taking strong CYP3A4 inhibitor or any other concomitant drug that, in the opinion of the PI, may cause interference with the treatment Subjects who participated in another drug or device trial within 4 weeks prior to screening...etc

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    PART 2 High-Dose

    PART 2 Low-Dose

    PART 2 Placebo

    Arm Description

    Active group selected for PART1 as a high-dose

    Active group selected for PART1 as a Low-dose

    Placebo group

    Outcomes

    Primary Outcome Measures

    Percentage change in Eczema Area and Severity Index (EASI) score
    To achieve lower score means disease improvement .

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Shaperon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06024499
    Brief Title
    Phase 2 Trial of HY209gel in Atopic Dermatitis Patients
    Official Title
    A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 31, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shaperon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.
    Detailed Description
    Part 1 (2 cohorts): Total 33 subjects Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo) Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo) Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo) Part 2 (3 treatment groups): Total 177 subjects Low dose of HY209gel: 59 subjects High dose of HY209gel: 59 subjects Placebo (Vehicle): 59 subjects Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe. Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Dermatitis of Scalp

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    A Randomized, Double-blind, Placebo-controlled Study
    Allocation
    Randomized
    Enrollment
    210 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PART 2 High-Dose
    Arm Type
    Active Comparator
    Arm Description
    Active group selected for PART1 as a high-dose
    Arm Title
    PART 2 Low-Dose
    Arm Type
    Active Comparator
    Arm Description
    Active group selected for PART1 as a Low-dose
    Arm Title
    PART 2 Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo group
    Intervention Type
    Drug
    Intervention Name(s)
    HY209GEL Active
    Intervention Description
    Selected two among three doses (HY209GEL 0.5% or 1% or 2%) in PART1
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Percentage change in Eczema Area and Severity Index (EASI) score
    Description
    To achieve lower score means disease improvement .
    Time Frame
    at Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Male or female subjects aged 18 or older Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist at least 6 months ago from screening Subjects who have a minimum of 5% and a maximum of 30% of total body surface area (BSA) affected by AD at screening and baseline visits Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit Subjects who can give written informed consent Key Exclusion Criteria: Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) or any consistent requirement for any potency topical corticosteroids Subjects who have topical treatment with corticosteroids within 2 weeks prior to baseline visit or other topical treatments of the AD area at screening (moisturizers/emollients are allowed) Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatments within 4 weeks prior to baseline visit Subjects who had dupilumab or any other biologics within 6 months prior to baseline visit Subjects who take any systemic anti-infective or antibiotic treatments within 1 week prior to baseline visit Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks prior to screening Subjects who have active malignancy or history of cancer in 5 years prior to screening, except for treated cautions basal cell carcinoma and in situ cervical cancer Subjects who have any other skin diseases that would affect the ability to assess the AD Subjects who are taking strong CYP3A4 inhibitor or any other concomitant drug that, in the opinion of the PI, may cause interference with the treatment Subjects who participated in another drug or device trial within 4 weeks prior to screening...etc

    12. IPD Sharing Statement

    Learn more about this trial

    Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

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