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

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

Interventions

DRUG

PG-011Gel

Twice daily for 52 weeks or 44 weeks

DRUG

Vehicle

Vehicle Gel twice daily for 8 weeks

Sponsors & Collaborators

• Prime Gene Therapeutics Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Xinghua Gao · First Hospital of China Medical University

• ZhiQiang Xie, Professor · Beijing Hospital

• Litao Zhang · Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

• Yunsheng Liang · Dermatology Hospital of Southern Medical University

• Wenli Feng · Second Hospital of Shanxi Medical University

• Chao Ji · First Affiliated Hospital of Fujian Medical University

• Aie Xu · Hangzhou Third People's Hospital

• Bingjiang Lin · First Affiliated Hospital of Ningbo University

• Lei Cao · Brief Introduction of Wuxi No.2 People's Hospital

• Rixin Chen · NANYANG FIRST PEOPLE'S HOSPITAL NATIONAL THIRD CLASS A HOSPITAL

• Liming Wu · Affiliated Hangzhou First People's Hospital， School of Medicine，WestLake University

• Yanyan Fen · Chengdu Second People's Hospital

• Yingxia He · GENERTEC LIAOYOUGEM FLOWER HOSPITAL

• Guoqiang Zhang · The First Hospital of Hebei Medical University

• Meiying Jiang · Second Affiliated Hospital of Nanchang University

• Linfeng Li · Beijing Friendship Hospital

• Wenli Yang · Second Affiliated Hospital of Guangzhou Medical University

• Zudong Meng · Shiyan Renmin Hospital

• Kunpeng Bian · Nanyang Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-15

Primary Completion

2024-11-19

Completion

2026-01-15

Countries

• China

Study Locations