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A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HY209 0.3%
HY209 0.5%
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

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 19 Years and older, Male or female
  • Those who have a clinical diagnosis of atopic dermatitis according to the criteria of Hanifin and Rajka
  • IGA of 2 or 3 at Baseline Visit
  • BSA covered with AD of at least 5% and no more than 40% at Baseline Visit
  • Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures until study completion

Exclusion Criteria:

  • Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate , aspirin, antibiotics, etc.)
  • Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery diseases, congestive heart failure, arrhythmia, cerebrovascular diseases, etc.) or who have a history of those diseases
  • Those who have systemic infection at Screening Visit
  • Those who have asthma at Screening Visit
  • Treatment with steroids, oral antibiotics, body photochemotherapy, immunosuppressive drug within 4 weeks before the Baseline Visit (Day 1)
  • Treatment with topical steroids, antibiotics within 2 weeks before the Baseline Visit (Day 1)
  • Those who have taken a prohibited concomitant medication
  • Those who have Creatinine values more than two times of the upper limit of normal range at screening test
  • Those who have AST/ALT values more than two times of the upper limit of normal range at screening test
  • Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 6 months prior to the date of first administering (the time from the date of participation in the previous clinical trial is based on the date of administration of each applicable study drug. However, if the half-life of the study drug taken in a previously participated clinical trial is 2 weeks or more, 5 times the expected half-life of the study drug)
  • Those who have history of HIV infection or HIV seropositivity at Screening Visit
  • Those who are positive or undeterminable in serological tests (HBsAg, HBcAb, or Hepatitis C virus antibody, Hepatitis B virus antibody) at Screening Visit
  • Those who have skin diseases or conditions affecting skin that may interfere with clinical trial evaluation (acne, impetigo, chicken pox, active herpes simplex at Baseline, corticosteroid induced perioral dermatitis, tinea corporis/intertriginous, head lice or scabies)
  • Those who have had malignant tumor within 5 years prior to Baseline Visit
  • Atopic Dermatitis treatment with topical drug (containing ceramide, hyaluronic acid, urea or filaggrin) during Screening period
  • Those who have a history of drinking or substance abuse within 2 years
  • Those who are positive urine drug screening tests at Screening Visit i.e., amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate, cotinine)
  • Those who are pregnant, breastfeeding, or considering pregnancy during the study
  • Those who are deemed unsuitable for participating in clinical trials under the judgement of investigator

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Hallym University Kangnam Scared Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

HY209 0.3%

HY209 0.5%

Placebo

Arm Description

multiple dose of HY209 0.3% gel

multiple dose of HY209 0.5% gel

multiple dose of Placebo

Outcomes

Primary Outcome Measures

Improvement rate in EASI score
As measured by Eczema Area and Severity Index (EASI)

Secondary Outcome Measures

Improvement rate in IGA score
As measured by Investigator Global Assessment (IGA)
Improvement rate Pruritus NRS
As measured by Pruritus Numeric Rating Scale (NRS)
Change in total IgE
As measured by total Immunoglobin E (IgE)
Change in Eosinophil count
As measured by Eosinophil count

Full Information

First Posted
August 25, 2020
Last Updated
January 27, 2022
Sponsor
Shaperon
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1. Study Identification

Unique Protocol Identification Number
NCT04530643
Brief Title
A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon)
Official Title
A Randomized, Double-blinded, Placebo-controlled, Parallel, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HY209 Gel for Patients With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Randomized, Double-blinded, Placebo-controlled, Parallel, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HY209 gel for Patients with Atopic Dermatitis
Detailed Description
A composition containing G Protein Coupled Receptor 19(GPCR19) agonist HY209 and a derivative thereof is found to have a considerable effect in the treatment of atopic dermatitis and is proposed as a pharmaceutical ingredient for prevention, treatment and improvement of atopic dermatitis. The GPCR19 agonist, HY209, is superior to conventional steroid ointment and immunosuppressant ointment in the treatment and improvement of allergic dermatitis. It directly reduces the amount of serum immunoglobulin E, which is a major factor of allergic dermatitis, It increases the T helper type 1(TH1) cytokines that alleviate allergic dermatitis pathologies, reduces the T helper type 2(TH2) cytokines that aggravate allergic dermatitis pathologies, and reduces the infiltration of mast cells, eosinophils and neutrophils into the dermal cells. Thus it can be utilized as a therapeutic drug composition for atopic dermatitis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HY209 0.3%
Arm Type
Experimental
Arm Description
multiple dose of HY209 0.3% gel
Arm Title
HY209 0.5%
Arm Type
Experimental
Arm Description
multiple dose of HY209 0.5% gel
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
multiple dose of Placebo
Intervention Type
Drug
Intervention Name(s)
HY209 0.3%
Other Intervention Name(s)
HY209 gel
Intervention Description
25 subjects will be assigned to drug (HY209 0.3% gel).
Intervention Type
Drug
Intervention Name(s)
HY209 0.5%
Other Intervention Name(s)
HY209 gel
Intervention Description
25 subjects will be assigned to drug (HY209 0.5% gel).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
25 subjects will be assigned to drug (Placebo).
Primary Outcome Measure Information:
Title
Improvement rate in EASI score
Description
As measured by Eczema Area and Severity Index (EASI)
Time Frame
Up to Week 4
Secondary Outcome Measure Information:
Title
Improvement rate in IGA score
Description
As measured by Investigator Global Assessment (IGA)
Time Frame
Up to Week 4
Title
Improvement rate Pruritus NRS
Description
As measured by Pruritus Numeric Rating Scale (NRS)
Time Frame
Up to Week 4
Title
Change in total IgE
Description
As measured by total Immunoglobin E (IgE)
Time Frame
Up to Week 4
Title
Change in Eosinophil count
Description
As measured by Eosinophil count
Time Frame
Up to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 19 Years and older, Male or female Those who have a clinical diagnosis of atopic dermatitis according to the criteria of Hanifin and Rajka IGA of 2 or 3 at Baseline Visit BSA covered with AD of at least 5% and no more than 40% at Baseline Visit Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures until study completion Exclusion Criteria: Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate , aspirin, antibiotics, etc.) Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery diseases, congestive heart failure, arrhythmia, cerebrovascular diseases, etc.) or who have a history of those diseases Those who have systemic infection at Screening Visit Those who have asthma at Screening Visit Treatment with steroids, oral antibiotics, body photochemotherapy, immunosuppressive drug within 4 weeks before the Baseline Visit (Day 1) Treatment with topical steroids, antibiotics within 2 weeks before the Baseline Visit (Day 1) Those who have taken a prohibited concomitant medication Those who have Creatinine values more than two times of the upper limit of normal range at screening test Those who have AST/ALT values more than two times of the upper limit of normal range at screening test Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 6 months prior to the date of first administering (the time from the date of participation in the previous clinical trial is based on the date of administration of each applicable study drug. However, if the half-life of the study drug taken in a previously participated clinical trial is 2 weeks or more, 5 times the expected half-life of the study drug) Those who have history of HIV infection or HIV seropositivity at Screening Visit Those who are positive or undeterminable in serological tests (HBsAg, HBcAb, or Hepatitis C virus antibody, Hepatitis B virus antibody) at Screening Visit Those who have skin diseases or conditions affecting skin that may interfere with clinical trial evaluation (acne, impetigo, chicken pox, active herpes simplex at Baseline, corticosteroid induced perioral dermatitis, tinea corporis/intertriginous, head lice or scabies) Those who have had malignant tumor within 5 years prior to Baseline Visit Atopic Dermatitis treatment with topical drug (containing ceramide, hyaluronic acid, urea or filaggrin) during Screening period Those who have a history of drinking or substance abuse within 2 years Those who are positive urine drug screening tests at Screening Visit i.e., amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate, cotinine) Those who are pregnant, breastfeeding, or considering pregnancy during the study Those who are deemed unsuitable for participating in clinical trials under the judgement of investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Scared Heart Hospital
City
Seoul
State/Province
Yeongdeungpo-gu
ZIP/Postal Code
07441
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon)

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