Clinical trial NCT04352595: A Phase Ⅱ Study of Hemay808 for Atopic Dermatitis Patients
Official title: Assess Hemay808 Concentration of Different Dosage Regimen for Mild and Moderate Atopic Dermatitis Patients the Safety and Efficacy of Multicenter, Randomized, Blinded, Excipient Parallel-group Phase Ⅱ Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* ≥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.

Exclusion Criteria:

* 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;
* 2 times the normal upper limit of ALT or AST \>, or the normal upper limit of Cr and \> of renal function (study allowed 1 reexamination, excluded if still not meeting the inclusion requirements);
* 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:

  1. . Received biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives, whichever is greater;
  2. . 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;
  3. . 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 \[zinc oxide oil (paste), black bean oil ointment, doxepin cream, etc.\];
  4. . 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;
* Female subjects who are suspected to be pregnant, lactating or preparing for pregnancy during the test;
* The subject plans to undergo surgery requiring hospitalization or surgery during his or her participation in the study;
* Those who participated in clinical studies of other drugs/devices and used experimental drugs/devices within the last 3 months of randomized enrollment;
* Other conditions made the researchers considered inappropriate for the study.

Primary outcomes:
measure: The change in the EASI score relative to the baseline.
timeFrame: Day 29
Secondary outcomes:
measure: The percentage of subjects achieving Investigator's Global Score (IGA) response which improvement ≥ 2 from baseline.
timeFrame: Day 8, Day 15, Day 22, Day 28
measure: The percentage of subjects achieving Investigator's Global Score (IGA) score 0-1.
timeFrame: Day 8, Day 15, Day 22, Day 28
measure: The change in the IGA score relative to the baseline.
timeFrame: Day 8, Day 15, Day 22, Day 28
measure: The percentage of subjects achieving EASI90, EASI75, EASI50.
timeFrame: Day 8, Day 15, Day 22, Day 28
measure: Absolute change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS).
timeFrame: Day 8, Day 15, Day 22, Day 28
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score.
timeFrame: Day 8, Day 15, Day 22, Day 28
measure: The percentage of AD invoved BSA (body surface area) change From Baseline.
timeFrame: Day 8, Day 15, Day 22, Day 28
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Dermotology hospital, Chinese academy of medical science
state: Jiangsu
city: Ningbo
country: China
facility: Ningbo second hospital
state: Zhejiang
Study officials:
References: