Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

A Randomized, Placebo-controlled, Double-blind, Multi Center, Phase IIa Trial Investigating the Safety, Tolerability, Pharmacokinetics and Efficacy of Topical Ointment YR001 in Adult Patients With Mild to Moderate Atopic Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06309355
• Other study ID #: YR001-A03
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Hangzhou Yirui Pharmaceutical Technology Co., Ltd
• Contact: Kevin Wei, Doctor
• Phone: +8615706771488
• Email: kai.wei[@]yirui-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent obtained from the subject.

2. Male or female subject is aged 18 or older.

3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.

4. An Investigator Static Global Assessment (ISGA) score of 2 (mild) to 3 (moderate) at screening and Baseline.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.

3. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet).

4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.

5. Participation in another interventional clinical trial (e.g. investigational drug, biological agent, or device) within 30 days or 5 half-lives of investigational agent (whichever is longer) before entering, or during the trial, or previous participation in this clinical trial.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• YR001 ointment
The intervention is YR001 ointment on a range of body surface area for multiple topical administration

Other:
• Placebo
The intervention is Placebo on a range of body surface area for multiple topical administration

Locations

Country	Name	City	State
United States	DelRicht Research	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Yirui Pharmaceutical Technology Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50.	incidence of treatment related AEs (TRAEs)	Day1-Day 50
Secondary	all treatment-emergents AEs	number, severity, causality, and outcome of all treatment-emergetns AEs (TEAEs)	Day1-Day 50
Secondary	Efficacy of YR001 Ointment	Proportion of patients achieving ISGA 0 or 1 by visit	Day1-Day50