Status:
RECRUITING
A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis
Lead Sponsor:
Prime Gene Therapeutics Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and...
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in adolescent and adult participants aged from 12 to 75 years old (including threshold) with mild to moderate Atopic ...
Eligibility Criteria
Inclusion
- 12 years old≤ age ≤ 75 years old (including threshold), male or female.
- Participants diagnosed of atopic dermatitis (AD) as defined by the Williams diagnostic criteria.
- AD/eczema duration of at least 1 year for adults and 6 months for adolescents.
- IGA score of 2 (mild) or 3 (moderate) at the screening day and day 1.
- %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20%.
- Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.
Exclusion
- Participant has unstable course of AD (spontaneously improving or rapidly deteriorating).
- Immunocompromised (e.g. lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
- Any other concomitant skin disorder(e.g. generalized erythroderma, Netherton syndrome, acne, psoriasis, urticaria, pigmentation or extensive scarring）, in the opinion of investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
- Participant with chronic or acute infection needs to be treated with systemic antibiotics, antiviral drugs, antiparasitic drugs, anti-antigenic animal drugs or antifungal drugs within 2 weeks before randomization.
- Participant with active acute/chronic bacterial, fungal or viral skin infections (such as herpes simplex, herpes zoster, chickenpox, etc.) before randomization, including but not limited to clinically significant secondary infections of AD or other infections associated with AD lesions.
- Participant has human immunodeficiency virus (HIV) infection, active hepatitis C virus (HCV) infection (anti-HCV positive), active hepatitis B virus (HBV) infection (HBV-DNA \> 2000IU/ml) or Treponema pallidum antibody positive and showing active.
- Clinically significant or uncontrolled cardiovascular disease (including but not limited to unstable angina, acute myocardial infarction, heart failure, arrhythmia requiring treatment or uncontrolled hypertension).
- Participant has serious diseases or complications of the central nervous system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or immune system, blood system, etc., and in the opinion of the investigator, may affect the judgment of efficacy and safety .
- Participant has mental illness such as anxiety disorder, depression, or other conditions that affect the compliance and may interfere with the implementation of clinical research.
- Participant has a history of malignant tumors before randomization.
- Participant has severe and uncontrolled disease that may affect safety, trial compliance, affect the evaluation of endpoints, and require the use of drugs that are not allowed in the protocol.
- Female participant who is lactating or pregnant at the time of screening.
- Any situation affects the safety and efficacy evaluation of the study drug judged by investigator.
- Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in the study.
Key Trial Info
Start Date :
March 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2026
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT06587685
Start Date
March 15 2024
End Date
January 15 2026
Last Update
May 20 2025
Active Locations (1)
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1
The First Hospital of China Medical University
Shenyang, Liaoning, China