GS101 Injection vs Dupixent for moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, parallel-group phase 3 study comparing GS101 injection to Dupixent® in adults with moderate-to-severe atopic dermatitis. Approximately 572 participants will be enrolled and randomized 1:1 to receive either GS101 or Dupixent®. The study will assess skin severity and symptoms to determine if GS101 provides similar benefits to the established treatment. Eligibility requires adults 18–75 with confirmed atopic dermatitis and moderate-to-severe disease at screening. Key exclusions include intolerance to study products, recent use of other investigational therapies, and recent receipt of live vaccines.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting

Study contacts

• Study coordinator: Sinian Li, Master
• Email: lisinian@jxingbio.com
• Phone: +086-15800767550

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

  A cream called roflumilast 0.3% is tested once daily to see if it helps people with moderate to severe atopic dermatitis, compared to a non-medicated cream, across ages 6 and up.

  Recruiting at 4 sites Phase 3 Arcutis Biotherapeutics, Inc. · Birmingham, Alabama and 3 other locations · NCT07916480

• LT-002-158 tablets for moderate-to-severe atopic dermatitis in adults

  This study tests LT-002-158 vs placebo to see if it helps adults with moderate-to-severe atopic dermatitis.

  Recruiting Phase 2 Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Hangzhou, Zhejiang · NCT07895615

• PRA-216 for moderate to severe atopic dermatitis: safety and how it works in the body

  This study tests PRA-216 versus placebo to see if it is safe and helps people with moderate to severe atopic dermatitis.

  Recruiting at 6 sites Phase 2 Prana Therapies Inc · Botany, New South Wales and 8 other locations · NCT07810777

• Skin structure in atopic dermatitis patients treated with nemolizumab assessed by reflectance confocal microscopy

  This study tests whether nemolizumab changes skin structure in adults with moderate-to-severe atopic dermatitis using a noninvasive imaging method.

  Recruiting Hôpitaux Drôme Nord · Romans-sur-Isère, Drôme · NCT07730788

• Global Health Look at Atopic Dermatitis

  A worldwide, multicenter study tests how people with atopic dermatitis access care and treat it, using data from routine medical records.

  Recruiting University of Zurich · Zurich · NCT07659756

• Stapokibart Injection for atopic dermatitis in adults

  This study tests Stapokibart Injection in adults with atopic dermatitis to see how safe it is and whether it helps.

  Recruiting Chengdu Kangnuoxing Biopharma,Inc. · Beijing, Beijing Municipality · NCT07544862

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.