A Phase Ⅱ Study of Hemay808 for Atopic Dermatitis Patients

NCT04352595 | Completed Phase 2

• 1 other identifier: HM808AD2S01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

Brief Summary

Assess Hemay808 concentration of 1%/3%/7% for treatment of mild and moderate adult atopic dermatitis patients.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• The change in the EASI score relative to the baseline.

  EASI Clinical Signs Severity Sum Score change from Baseline at Day 29

  Day 29

Secondary Outcomes (7)

• The percentage of subjects achieving Investigator's Global Score (IGA) response which improvement ≥ 2 from baseline.

  Day 8, Day 15, Day 22, Day 28

• The percentage of subjects achieving Investigator's Global Score (IGA) score 0-1.

  Day 8, Day 15, Day 22, Day 28

• The change in the IGA score relative to the baseline.

  Day 8, Day 15, Day 22, Day 28

• The percentage of subjects achieving EASI90, EASI75, EASI50.

  Day 8, Day 15, Day 22, Day 28

• Absolute change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS).

  Day 8, Day 15, Day 22, Day 28

Study Arms (4)

1% Hemay808

EXPERIMENTAL

Drug: Hemay808

3% Hemay808

EXPERIMENTAL

Drug: Hemay808

7% Hemay808

EXPERIMENTAL

Drug: Hemay808

vehicle

PLACEBO COMPARATOR

Drug: Hemay808

Interventions

Hemay808 DRUG

Hemay808 is a onitment of Hemay028, a small molecule PDE4 inhibitor.

1% Hemay808; 3% Hemay808; 7% Hemay808; vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old and ≤65 years old, gender is not limited;
• It met the diagnostic criteria for atopic dermatitis (AD) of Hanifin\&Rajka, and the history of AD before screening was ≥6 months;
• The investigator's overall score (IGA) at the screening period/baseline visit was 2-3;
• The skin lesion area of atopic dermatitis (excluding scalp lesions) is 3%-20% of body surface area (BSA) and suitable for local treatment;
• During the study period and within 3 months after the last administration, fertile female subjects and male subjects who did not receive vasectomy were required to take effective contraceptive measures;
• Those who have full knowledge of the test, participate in the test voluntarily and sign the informed consent.

You may not qualify if:

• The lesion area of AD is infected and requires local or systematic treatment with anti-infective drugs, or external administration of strong or potent glucocorticoids (see annex 4) or systematic administration of glucocorticoids to control AD Useing of systemic glucocorticoids and/or immunosuppressants within 4 weeks; Or sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.); Or systematic use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis;
• The AD lesion area was marked, tattooed, or hyperpigmented, and was judged by the investigator to interfere with the evaluation of the response to the study's drug therapy;
• Previous use of systemic or local pde-4 inhibitors;
• Suffering from clinically significant active systemic infections;
• Unwilling to limit their excessive uv exposure during the study period (e.g., sunbathing and/or tanning devices);
• Received the following treatment in the limited time period prior to baseline evaluation:
• Received biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives, whichever is greater;
• Use of systemic glucocorticoids and/or immunosuppressants within 4 weeks; Or sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.); Or systematic use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis;
• The following treatment was administered within 2 weeks: systemic anti-infective drugs (both oral and intravenous); Or local use of glucocorticoid or local use of calcineurin inhibitor; Local use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis; Or other topical drugs for the treatment of atopic dermatitis \[zinc oxide oil (paste), black bean oil ointment, doxepin cream, etc.\];
• Local anti - microbial preparation was used within 1 week;
• Suffering from serious diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal system, urinary system, endocrine system or blood system, and the researcher believes that may confused result or affect the safety of the subjects;
• Suffering from a serious mental illness or other condition that affects research compliance and may interfere with the conduct of clinical trials;
• A history of malignant tumor;
• With a history of severe allergic reactions to skin topical preparations (including angioedema, allergic reactions, etc.) or known allergic reactions to Hemay808 accessories;
• Screening people who had a long history of drug abuse or alcohol abuse in the first 6 months;

Sponsors & Collaborators

• Tianjin Hemay Pharmaceutical Co., Ltd: lead

Study Sites (2)

Dermotology hospital, Chinese academy of medical science

Nanjing, Jiangsu, 210042, China

Location

Ningbo second hospital

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 20, 2020
• Study Start: April 24, 2020
• Primary Completion: February 28, 2021
• Study Completion: April 2, 2021
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)