RecruitingPhase 3interventionalRules rewrite

Phase 3: testing GS101 injection for Atopic Dermatitis (AD)

This is a a multicenter, randomly assigned, 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 randomly assigned at a ratio of 1:1 to receive GS101 injection or Dupixent®

Official registry: https://clinicaltrials.gov/study/NCT07386743 · Jiangsu Genscend Biopharmaceutical Co., Ltd · enrollment listed as 572

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are GS101 injection, or DUPIXENT®. The registry lists allocation as randomized. This is a a multicenter, randomly assigned, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis.

They plan to enroll about 572 people at Shenyang. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: GS101 injection, DUPIXENT®

Primary outcome (registry wording): Proportion of patients achieving EASI-75 at week 16

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
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%

Who the registry excludes

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

Public study contact (from the registry)

Sinian Li, Master

+086-15800767550

lisinian@jxingbio.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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

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FAQ about this NCT record

Is NCT07386743 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07386743?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07386743?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary