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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07386743
- Acronym / sponsor ID
- GS101-03
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- Jiangsu Genscend Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS101 injection | Experimental | Drug: GS101 injection |
| Dupixent® | Active comparator | Drug: DUPIXENT® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS101 injection300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous injection | Drug | GS101 injection |
| DUPIXENT®300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection | Drug | Dupixent® |
Primary outcome
Proportion of patients achieving EASI-75 at week 16
Time frame: 16 weeks
EASI-75
3 secondary outcomes
Proportion of patients achieving EASI-75
Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Proportion of patients achieving EASI-50
Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Proportion of patients achieving EASI-90
Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
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
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sinian Li, Master (+086-15800767550, lisinian@jxingbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving EASI-75 at week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.