Dermatitis, AtopicPhase 3NCT07042126
Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing 611 in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 sites in China.
Trial summary
The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- 611
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 5 Aug 2025to 30 Sep 2027
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subjects and their legal guardians are able to understand and comply with the research procedures, agree to participate in the research, and sign the Informed Consent Form (ICF).
- When signing the informed consent form, the age should be ≥ 12 years old and < 18 years old, gender is not restricted, and the body weight should be ≥ 30 kg at the screening and baseline.
- During the screening process, patients were diagnosed with atopic dermatitis (AD) according to the Hanifin - Rajka criteria, and their AD medical history was evaluated by researchers to be ≥ 6 months (the diagnostic criteria are not restricted for the medical history).
- At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points.
- At the screening and baseline, the Investigator Global Assessment (IGA) score is ≥3 points.
- At the time of screening and baseline, the affected body surface area (BSA) by atopic dermatitis (AD) is ≥10%.
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- At baseline, the weekly average score of the Numerical Rating Scale (NRS) for pruritus was ≥ 4 points.
- Subjects should have relevant medical records, other medical visit records, or other evidence within the previous year for researchers to evaluate. The subjects have poor efficacy of topical drug treatment, or are medically unsuitable for topical drug treatment.
- Be willing to use a stable dose of emollient (moisturizer) on the affected areas of atopic dermatitis (AD) twice a day for at least 7 days before randomization and continue to use it throughout the study period.
- Subjects with potential fertility (e.g., females who have experienced menarche or males who have had nocturnal emissions) must agree to avoid sexual activity or use highly effective contraceptive methods throughout the entire study period and for at least 3 months after the last dose of the medication.Subjects should have no plans for reproduction, sperm donation, or egg donation during the entire study period and for at least 3 months after the last dose of the medication.
- Be able to understand and complete (either independently or with the assistance of a guardian) the research - related questionnaire filling.
Who cannot join
- Merge other skin comorbidities that may interfere with the research evaluation.
- Combined with active parasitic infections (such as helminths) or suspected parasitic infections (subjects who have excluded active infections through clinical and/or laboratory examinations before randomization can be enrolled).
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- Randomly select patients with any malignant tumor diagnosed within the past 5 years or currently having the disease (excluding basal cell carcinoma that has been cured for ≥ 1 year, local cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix).
- The subject had a severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks before randomization, or had an active infection requiring oral antibiotics within 2 weeks before randomization, and the investigator evaluated that there might be uncontrollable risks for the subject to participate in this study.
- A history of known or suspected immunosuppression, including a history of invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis); or those who, although the infection has resolved, are considered by the investigator to be likely to have frequent recurrences.
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- Those with evidence of active tuberculosis, or those who have had active tuberculosis in the past but cannot provide sufficient evidence of treatment, or those who are judged to potentially have active tuberculosis infection based on examinations such as chest X - ray or CT, medical history, contact history, symptoms, and physical signs.
- The researchers believe that there are any diseases that are severe or unstable and may affect the safety of the subjects during the study and/or prevent the subjects from completing the study, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, and mental diseases.
- Currently receiving or having received the following treatments:
- Within the first 2 weeks randomly selected, patients have received topical drug treatment for atopic dermatitis (AD), such as TCS, TCI, PDE inhibitors, Janus kinase (JAK) inhibitors, etc.
- Within the first 4 weeks before randomization, the patients received systemic treatment with traditional Chinese medicine (TCM) of unknown nature or with therapeutic effects on AD. Or within the first 1 week before randomization, they received topical treatment with Chinese herbal medicine of unknown nature or with therapeutic effects on AD.
- Received systemic glucocorticoids or other immunosuppressants/immunomodulators (including but not limited to cyclosporine, mycophenolate mofetil, interferon γ [IFN-γ], JAK inhibitors, compound glycyrrhizin, azathioprine, mycophenolate mofetil, and methotrexate) randomly within the first 4 weeks or 5 half - lives (whichever is longer).
- Received phototherapy (including but not limited to narrow - band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen plus ultraviolet A [PUVA]), tanning beds, or any other light - emitting devices with therapeutic effects on atopic dermatitis (AD) within the first 4 weeks randomly.
- Randomly selected patients who had received allergen-specific immunotherapy (SIT) within the previous 6 months.
- Received any monoclonal antibody therapy (such as dupilumab, etc.) within the first 4 months randomly or within 5 half-lives (whichever is longer) before randomization; Received any cell - depleting agents, including but not limited to rituximab, within 6 months before randomization.
- As judged by the researchers, patients had no response or poor efficacy to previous treatment with anti-IL-4 and/or IL-13 drugs (such as dupilumab, etc.).
- Previously, 611 was used.
- Treatment of atopic dermatitis (AD) with prescription emollients or emollients containing additives is initiated during the screening period.
- Received live vaccines or live attenuated vaccines within the first 4 weeks before randomization.
- If any of the examination indicators before screening or randomization meet the following criteria and are judged by the researcher as unsuitable for inclusion in the study:TBIL≥1.5 ULN ;ALT/AST ≥2 ULN；Cr>1.5 ULN; blood WBC is lower than LLN, which is judged by the researcher to be clinically significant and makes the subject ineligible for the study.
- At the screening, the test results are positive for hepatitis B, positive for hepatitis C virus antibody (HCVAb), positive for human immunodeficiency virus antibody (HIVAb), and positive for serum Treponema pallidum antibody (TPAb).
- Used any investigational drugs within the first 8 weeks after randomization or 5 half-lives (whichever is longer);
- Had a history of alcohol or drug abuse within 6 months before randomization;
- Known to be allergic or intolerant to any components of the investigational drug;
- Planned or were expected to undergo major surgical operations during the study period;
- Pregnant women, women planning to become pregnant during the study period, or breastfeeding women;
- According to the investigator's judgment, the subjects were not suitable to participate in the study due to other diseases or reasons.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jianzhong Zhang, Doctor, 010-88325472, rmzjz@126.com
Jianzhong Zhang
- Recruiting
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Jinhua, Zhejiang, 322000
Lunfei Liu, Master, 13858036789, liulunfei_zeyy@163.com
Lunfei Liu
- Recruiting
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Nanchang, Zhejiang, 310003
Liming Wu, Doctor, 13750837205, 18957118053@163.com
Liming Wu
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Ccontrolled Phase Ⅲ Clinical Trail， to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adolescents (12 Years Old≤Age < 18 Years Old) With Moderate to Severe Atopic Dermatitis (AD)
The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.
Read the detailed description
The maximum study duration was 64 weeks per participants, including a screening period of up to 4 weeks, a 16-week Double blind treatment period，a 36-week maintenance treatment period ，and an 8-week follow-up period.
- Conditions
- Dermatitis, Atopic
- Being tested
- 611, Matching placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
611Drug
Double blind treatment period : 611 600 mg/450 mg at day 1，then 300 mg subcutaneous injection Q2W thereafter until week 16 Maintenance treatment period : 611 300 mg subcutaneous injection Q2W/Q3W until week 52.（The subjects in the placebo group during the double-blind treatment period need to be given a loading dose at week 16.）
Matching placeboDrug
Double blind treatment period : placebo subcutaneous injection Q2W until week 16.
| Study group | Role | What they receive |
|---|---|---|
| 611 | Experimental | Not described Receives: Drug: 611 |
| placebo | Placebo comparator | Not described Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
Measured: Baseline, Week 16
Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to Week 16
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity
Measured: Baseline to Week 16
Secondary outcomes (5)
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point except for Week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
Measured: Baseline, Week 60
Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to each efficacy evaluation visit point except for Week 16
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Measured: Baseline to Week 60
Number of Participants With EASI-50 (>=50% Improvement From Baseline)
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Measured: Baseline to Week 60
Number of Participants With EASI-90 (>=90% Improvement From Baseline)
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
Measured: Baseline, Week 60
Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.
Measured: Baseline, Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start5 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042126
- Sponsor's protocol ID
- SSGJ-611-PED-AD-III-01
- Status last verified
- Oct 2025
- First submitted
- 6 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Ccontrolled Phase Ⅲ Clinical Trail， to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adolescents (12 Years Old≤Age < 18 Years Old) With Moderate to Severe Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT07042126
- Acronym / sponsor ID
- SSGJ-611-PED-AD-III-01
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Jun 2025 (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.
The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.
Detailed description
The maximum study duration was 64 weeks per participants, including a screening period of up to 4 weeks, a 16-week Double blind treatment period，a 36-week maintenance treatment period ，and an 8-week follow-up period.
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 |
|---|---|---|
| 611 | Experimental | Drug: 611 |
| placebo | Placebo comparator | Drug: Matching placebo |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- The subjects and their legal guardians are able to understand and comply with the research procedures, agree to participate in the research, and sign the Informed Consent Form (ICF).
- When signing the informed consent form, the age should be ≥ 12 years old and < 18 years old, gender is not restricted, and the body weight should be ≥ 30 kg at the screening and baseline.
- During the screening process, patients were diagnosed with atopic dermatitis (AD) according to the Hanifin - Rajka criteria, and their AD medical history was evaluated by researchers to be ≥ 6 months (the diagnostic criteria are not restricted for the medical history).
- At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points.
- At the screening and baseline, the Investigator Global Assessment (IGA) score is ≥3 points.
Key exclusion criteria (27 listed)
- Merge other skin comorbidities that may interfere with the research evaluation.
- Combined with active parasitic infections (such as helminths) or suspected parasitic infections (subjects who have excluded active infections through clinical and/or laboratory examinations before randomization can be enrolled).
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- Randomly select patients with any malignant tumor diagnosed within the past 5 years or currently having the disease (excluding basal cell carcinoma that has been cured for ≥ 1 year, local cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix).
- The subject had a severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks before randomization, or had an active infection requiring oral antibiotics within 2 weeks before randomization, and the investigator evaluated that there might be uncontrollable risks for the subject to participate in this study.
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 |
|---|---|---|
| 611Double blind treatment period : 611 600 mg/450 mg at day 1，then 300 mg subcutaneous injection Q2W thereafter until week 16 Maintenance treatment period : 611 300 mg subcutaneous injection Q2W/Q3W until week 52.（The subjects in the placebo group during the double-blind treatment period need to be given a loading dose at week 16.） | Drug | 611 |
| Matching placeboDouble blind treatment period : placebo subcutaneous injection Q2W until week 16. | Drug | placebo |
Primary outcome
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
Time frame: Baseline, Week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to Week 16
Time frame: Baseline to Week 16
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity
5 secondary outcomes
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point except for Week 16
Time frame: Baseline, Week 60
Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to each efficacy evaluation visit point except for Week 16
Time frame: Baseline to Week 60
Number of Participants With EASI-50 (>=50% Improvement From Baseline)
Time frame: Baseline to Week 60
Number of Participants With EASI-90 (>=90% Improvement From Baseline)
Time frame: Baseline, Week 60
Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline
Time frame: Baseline, Week 60
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 18 Nov 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 611 in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 sites 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 11 inclusion and 27 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 Qinghong Zhou, Master (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16 (time frame: Baseline, Week 16). The study lists 2 primary outcomes in all. 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 18 Nov 2025.