Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Last updated: April 24, 2024
Sponsor: Shaperon
Overall Status: Active - Recruiting

Phase

2

Condition

Skin Infections/disorders

Eczema (Atopic Dermatitis - Pediatric)

Eczema (Atopic Dermatitis)

Treatment

HY209GEL Active

Placebo

Clinical Study ID

NCT06024499
HY209-AD-02
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female subjects aged 18 or older
  • Subjects who have a history of AD at least 6 months ago from screening and have beenclinically stable for ≥ 1 month
  • Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteriaby a board certified/eligible dermatologist
  • 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 andbaseline visit
  • Subjects should be a literate person who can read the participant information sheetand consent form/questionnaire and understand the language of the participation

Exclusion

Key Exclusion Criteria:

  • Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) orany consistent requirement for any potency topical corticosteroids
  • Subjects who have topical treatment with corticosteroids within 2 weeks prior tobaseline 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 otherimmunosuppressive treatments within 4 weeks prior to baseline visit
  • Subjects who had dupilumab or any other biologics within 6 months prior to baselinevisit
  • Subjects who take any systemic anti-infective or antibiotic treatments within 1 weekprior to baseline visit
  • Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeksprior to screening
  • Subjects who have active malignancy or history of cancer in 5 years prior toscreening, except for treated cautions basal cell carcinoma and in situ cervicalcancer
  • Subjects who have any other skin diseases that would affect the ability to assess theAD
  • Subjects who are taking strong CYP3A4 inhibitor or any other concomitant drug that, inthe opinion of the PI, may cause interference with the treatment
  • Subjects who participated in another drug or device trial within 4 weeks prior toscreening...etc

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: HY209GEL Active
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Cahaba Dermatology Skin Health Center

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • RAOOF MD Dermatology

    Encino, California 16133
    United States

    Active - Recruiting

  • Continental Clinical Solutions, LLC

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • Sadick Dermatology

    New York, New York 10075
    United States

    Active - Recruiting

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