Clincosm LogoSign in Get a demo

Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Sponsor
Shaperon (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06024499
Collaborator
(none)
210
Enrollment
3
Arms
27
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Anticipated 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)
Anticipated Study Start Date :
Dec 31, 2023
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PART 2 High-Dose

Active group selected for PART1 as a high-dose

Drug: HY209GEL Active
Selected two among three doses (HY209GEL 0.5% or 1% or 2%) in PART1
Active Comparator: PART 2 Low-Dose

Active group selected for PART1 as a Low-dose

Drug: HY209GEL Active
Selected two among three doses (HY209GEL 0.5% or 1% or 2%) in PART1
Placebo Comparator: PART 2 Placebo

Placebo group

Other: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Percentage change in Eczema Area and Severity Index (EASI) score [at Week 8]

    To achieve lower score means disease improvement .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shaperon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shaperon
ClinicalTrials.gov Identifier:
NCT06024499
Other Study ID Numbers:
  • HY209-AD-02
First Posted:
Sep 6, 2023
Last Update Posted:
Sep 6, 2023
Last Verified:
Jul 1, 2023
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:
Dermatitis, Atopic
Dermatitis
Eczema

Study Results

No Results Posted as of Sep 6, 2023