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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: HY209 0.3%; Drug: HY209 0.5%; Drug: Placebo

• Registration Number: NCT04530643
• Lead Sponsor: Shaperon

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.

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study Start: 2020-08-26
• Study First Posted: 2020-08-28
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HY209 0.3%	HY209 0.3%	multiple dose of HY209 0.3% gel
HY209 0.5%	HY209 0.5%	multiple dose of HY209 0.5% gel
Placebo	Placebo	multiple dose of Placebo

Primary Outcome Measures

Name	Time	Method
Improvement rate in EASI score	Up to Week 4	As measured by Eczema Area and Severity Index (EASI)

Secondary Outcome Measures

Name	Time	Method
Improvement rate in IGA score	Up to Week 4	As measured by Investigator Global Assessment (IGA)
Change in total IgE	Up to Week 4	As measured by total Immunoglobin E (IgE)
Improvement rate Pruritus NRS	Up to Week 4	As measured by Pruritus Numeric Rating Scale (NRS)
Change in Eosinophil count	Up to Week 4	As measured by Eosinophil count

Trial Locations

Locations (3)

Hallym University Kangnam Scared Heart Hospital; 🇰🇷 Seoul, Yeongdeungpo-gu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of