Atopic Dermatitis (AD)Phase 3NCT07386743
A Phase III Study of GS101 Injection to Dupixent®
A Phase 3 study testing GS101 injection and DUPIXENT® in people with Atopic Dermatitis (AD), run by Jiangsu Genscend Biopharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- GS101 injection and DUPIXENT®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to Jan 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Xinghua Gao, M.D., 024-83282524, gaobarry@hotmail.com
Xinghua Gao, M.D.
About this study
Official title: 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
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®
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- GS101 injection, DUPIXENT®
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS101 injectionDrug
300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous injection
DUPIXENT®Drug
300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| GS101 injection | Experimental | Not described Receives: Drug: GS101 injection |
| Dupixent® | Active comparator | Not described Receives: Drug: DUPIXENT® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving EASI-75 at week 16
EASI-75
Measured: 16 weeks
Secondary outcomes (3)
Proportion of patients achieving EASI-75
Proportion of patients achieving EASI-50 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Measured: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Proportion of patients achieving EASI-50
Proportion of patients achieving EASI-50 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Measured: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Proportion of patients achieving EASI-90
Proportion of patients achieving EASI-90 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Measured: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start29 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Genscend Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386743
- Sponsor's protocol ID
- GS101-03
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No