Assessing PG-011 Gel for Treating Atopic Dermatitis in Adolescents and Adults

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of PG-011 Gel With 8 Weeks Treatment and Extension Safety Study to 52 Weeks in Adolescents and Adults With Atopic Dermatitis

This study is testing a new gel called PG-011 to see if it can help teenagers and adults with mild to moderate eczema feel better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 472 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Prime Gene Therapeutics Co., Ltd. (industry)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06587685 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of PG-011 gel in treating mild to moderate atopic dermatitis in adolescents and adults aged 12 to 75. Participants will be randomly assigned to receive either PG-011 gel or a placebo for an initial 8 weeks, followed by an open-label treatment phase lasting 44 weeks. The study aims to determine how well PG-011 gel works compared to a placebo and to monitor its long-term safety. Participants will attend clinic visits for assessments and tests throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults aged 12 to 75 with mild to moderate atopic dermatitis.

Not a fit: Patients with unstable atopic dermatitis or other significant skin disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing atopic dermatitis in adolescents and adults.

How similar studies have performed: Other studies have shown promise in treating atopic dermatitis with similar topical therapies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. 12 years old≤ age ≤ 75 years old (including threshold), male or female.
2. Participants diagnosed of atopic dermatitis (AD) as defined by the Williams diagnostic criteria.
3. AD/eczema duration of at least 1 year for adults and 6 months for adolescents.
4. IGA score of 2 (mild) or 3 (moderate) at the screening day and day 1.
5. %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20%.
6. Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.

Exclusion Criteria:

1. Participant has unstable course of AD (spontaneously improving or rapidly deteriorating).
2. Immunocompromised (e.g. lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
3. 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.
4. 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.
5. 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.
6. 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.
7. Clinically significant or uncontrolled cardiovascular disease (including but not limited to unstable angina, acute myocardial infarction, heart failure, arrhythmia requiring treatment or uncontrolled hypertension).
8. 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 .
9. 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.
10. Participant has a history of malignant tumors before randomization.
11. 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.
12. Female participant who is lactating or pregnant at the time of screening.
13. Any situation affects the safety and efficacy evaluation of the study drug judged by investigator.
14. Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in the study.

Where this trial is running

Shenyang, Liaoning

• The First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Principal investigator: ZhiQiang Xie, Professor — Beijing Hospital
• Study coordinator: Xinghua Gao, Professor

Conditions: Atopic Dermatitis, PG-011, Pumecitinib, Atopic, Dermatitis