A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis

NCT06587685 | Recruiting Phase 3 DMC

• 2 other identifiers: PG-011-AD-301CTR20230499
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

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 Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time. The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis. Participants will:

• Use PG-011gel or a placebo twice daily for initial 8 weeks, and followed by using PG-011 gel for all of the participants till 52-week.
• Visit the clinic at weeks 1, 2, 4 and 8 for checkups and tests, and followed by visiting the clinic every 4 weeks till 52-week.
• Keep a diary of their symptoms.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; PG-011; Pumecitinib; Atopic; Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieved Eczema Area and Severity Index (EASI 75) at Week 8

  Defined as ≥ 75% improvement in Eczema Area and Severity Index score. The EASI score ranges from 0 to 72, higher score indicates greater severity.

  8-week

Secondary Outcomes (28)

• Key Secondary Outcome: Investigators Global Assessment (IGA) score of 0/1 at Week 8

  8-week

• Proportion change of eczema area and severity index (EASI) at each scheduled visit

  Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

• Change of eczema area and severity index (EASI) score at each scheduled visit

  Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

• Change from baseline of Itch Numeric Rating Scale (NRS) at each scheduled visit

  Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52

• Proportion change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit

  Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52

Study Arms (2)

PG-011Gel 3%

EXPERIMENTAL

Topically administered Pumecitinib Gel 3% to the skin twice daily for 52 or 44 weeks

Drug: PG-011Gel

Vehicle Gel

PLACEBO COMPARATOR

Topically administered the Vehicle Gel to the skin twice daily for 8 weeks

Drug: Vehicle

Interventions

PG-011Gel DRUG

Twice daily for 52 weeks or 44 weeks

Also known as: PG-011Gel 3%

PG-011Gel 3%

Vehicle DRUG

Vehicle Gel twice daily for 8 weeks

Also known as: placebo

Vehicle Gel

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prime Gene Therapeutics Co., Ltd.: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Related Links

• IGA, Investigator's Global Assessment

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Xinghua Gao

  First Hospital of China Medical University

  STUDY CHAIR

• ZhiQiang Xie, Professor

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

• Litao Zhang

  Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

  PRINCIPAL INVESTIGATOR

• Yunsheng Liang

  Dermatology Hospital of Southern Medical University

  PRINCIPAL INVESTIGATOR

• Wenli Feng

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Chao Ji

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Aie Xu

  Hangzhou Third People's Hospital

  PRINCIPAL INVESTIGATOR

• Bingjiang Lin

  First Affiliated Hospital of Ningbo University

  PRINCIPAL INVESTIGATOR

• Lei Cao

  Brief Introduction of Wuxi No.2 People's Hospital

  PRINCIPAL INVESTIGATOR

• Rixin Chen

  NANYANG FIRST PEOPLE'S HOSPITAL NATIONAL THIRD CLASS A HOSPITAL

  PRINCIPAL INVESTIGATOR

• Liming Wu

  Affiliated Hangzhou First People's Hospital， School of Medicine，WestLake University

  PRINCIPAL INVESTIGATOR

• Yanyan Fen

  Chengdu Second People's Hospital

  PRINCIPAL INVESTIGATOR

• Yingxia He

  GENERTEC LIAOYOUGEM FLOWER HOSPITAL

  PRINCIPAL INVESTIGATOR

• Guoqiang Zhang

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Meiying Jiang

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Linfeng Li

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Wenli Yang

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Zudong Meng

  Shiyan Renmin Hospital

  PRINCIPAL INVESTIGATOR

• Kunpeng Bian

  Nanyang Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinghua Gao, Professor

CONTACT

+86-13940152467; barrygao@hotmail.com

Li Zhang, Professor

CONTACT

lizhang_100l@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: August 14, 2024
• First Posted: September 19, 2024
• Study Start: March 15, 2024
• Primary Completion: November 19, 2024
• Study Completion: January 15, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)