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Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06024499
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Shaperon

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Atopic Dermatitis Eczema Atopic Dermatitis of Scalp Drug: HY209GEL Active Other: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A Randomized, Double-blind, Placebo-controlled Study
Primary Purpose: Treatment
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)
Actual Study Start Date : March 1, 2024
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PART 2 High-Dose
Active group selected for PART1 as a high-dose
 Drug: HY209GEL Active
Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1
Active Comparator: PART 2 Low-Dose
Active group selected for PART1 as a Low-dose
 Drug: HY209GEL Active
Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1
Placebo Comparator: PART 2 Placebo
Placebo group
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change in Eczema Area and Severity Index (EASI) score [ Time Frame: at Week 8 ]
    To achieve lower score means disease improvement .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 been clinically stable for ≥ 1 month
  • Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by 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 and baseline visit
  • Subjects should be a literate person who can read the participant information sheet and consent form/questionnaire and understand the language of the participation

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06024499


Contacts
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Contact: Shaperon Shaperon 82-2-6083-8315 seoh@shaperon.com
Contact: Shaperon Shaperon

Locations
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United States, Alabama
Cahaba Dermatology Skin Health Center Recruiting
Birmingham, Alabama, United States, 35244
Contact: Dr. Groysman         
United States, California
RAOOF MD Dermatology Recruiting
Encino, California, United States, 16133
Contact: Dr. Raoof         
United States, Maryland
Continental Clinical Solutions, LLC Recruiting
Towson, Maryland, United States, 21204
Contact: Dr. Mardiney         
United States, New York
Sadick Dermatology Recruiting
New York, New York, United States, 10075
Contact: Dr. Sadick         
Sponsors and Collaborators
Shaperon
More Information
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Responsible Party: Shaperon
ClinicalTrials.gov Identifier: NCT06024499    
Other Study ID Numbers: HY209-AD-02
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: July 2023

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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
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases