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A Phase III Study of GS101 Injection to Dupixent® | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

A Phase III Study of GS101 Injection to Dupixent®

A Multicenter, Randomized, Double-blinded, Parallel, Positive-controlled, Phase III Comparative Study to Evaluate GS101 Injection Versus Dupixent® in Participants With Moderate-to-Severe Atopic Dermatitis

NCT07386743•Jiangsu Genscend Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects, male or female, between the ages of 18 and 75 years (inclusive)
•At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening
•During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%.

Exclusion Criteria

•Hypersensitivity or known allergy to the investigational product(s) or any of their excipients
•Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer
•Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period

Locations (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

April 1, 2027

Completion Date

January 1, 2028

Last Updated

February 4, 2026

Enrollment

572

ESTIMATED participants

Conditions

Atopic Dermatitis (AD)

Interventions

GS101 injection

DRUG

DUPIXENT®

DRUG

Contacts

Sinian Li, Master

CONTACT

+086-15800767550 lisinian@jxingbio.com

Tao Sun, Master

CONTACT

+086-15921575347 suntao@jxingbio.com

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

NCT07298395

Atopic Dermatitis (AD)

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A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

NCT07235384

Atopic Dermatitis (AD)

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RECRUITINGNA

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase III Study of GS101 Injection to Dupixent®

Inclusion Criteria

Exclusion Criteria

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Herbal Ointment in Treating Atopic Dermatitis Topically

Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis