AzTrials
AzTrials

Dermatitis, AtopicPhase 3NCT07767253

Evaluation of 611 in Chinese Children With Moderate to Severe Atopic Dermatitis(AD)

A Phase 3 study testing 611 in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a 2-part (parts A and B) study.The primary objective of the study is to evaluate the efficacy of 611 in Chinese Children with moderate to severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 2 to 11 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
246 participants
Where
5 sitesChina
Study dates
22 Sep 2026to Jul 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 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The participants and their legally acceptable representatives 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 ≥ 2 years old and < 6 years old for part A, and ≥ 2 years old and < 12 years old for part B. any gender, with body weight ≥ 15 kg at 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 for participants aged ≥2 years to <6 years, ≥ 3 months for participants aged ≥6 years to <12 years;
  • 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%;
Show all 11Show fewer
  • At baseline, the weekly average score of Daily pruritus Numerical Rating Scale (NRS) is ≥ 4 points;
  • Participants should have relevant medical records, other medical visit records, or other evidence within the previous year for researchers to evaluate. The participants have poor efficacy of 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;
  • Participants 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;
  • The participants (if applicable) and their legally acceptable representatives shall be able to understand and complete (either independently or with the assistance of a guardian) the research - related questionnaire filling.

Who cannot join

  • Intolerance to TCS / TCI treatment or contraindications to TCS / TCI;
  • Merge other skin comorbidities that may interfere with the research evaluation;
  • Combined with active parasitic infections (such as helminths) or suspected parasitic infections ;
  • 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;
  • The participant 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 participant to participate in this study. Or with a skin infection that requires treatment with topical anti-infective agents within 1 week before randomization;
Show all 18Show fewer
  • A history of known or suspected immunosuppression, including a history of invasive opportunistic infections; or those who, although the infection has resolved, are considered by the investigator to be likely to have frequent recurrences;
  • Active tuberculosis, unless that was well documented that the participants had adequately treated;
  • Any medical condition that, in the opinion of the investigator, is serious or unstable and may affect the safety of the participants during the study and/or prevent the participants from completing the study, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, and mental diseases;
  • Participants who have received topical therapies for AD systemic traditional Chinese medicine for AD, systemic glucocorticoids, or other immunosuppressants / immunomodulators, any cell-depleting agents, monoclonal antibodies within a specified period prior to randomization.
  • Received live vaccines or live attenuated vaccines within 4 weeks before randomization;
  • Participants with abnormal laboratory parameters deemed ineligible for enrollment at the Investigator's discretion. ;
  • 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 8 weeks or 5 half-lives (whichever is longer) before randomization;
  • 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;
  • According to the investigator's judgment, the participants were not suitable to participate in the study due to other diseases or reasons.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qinghong Zhou, Master contact

+86 18911301578

zhouqinghong@3sbio.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

    Lin Ma, Doctor, +86 13601305676, bch_maleen@aliyun.com

    Lin Ma

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Fenglin Zhuo, Doctor, +86 15910895068, zflsunny@hotmail.com

    Fenglin Zhuo

    Not yet recruiting

  • Hunan Children's Hospital

    Changsha, Hunan, 410007

    Zhu Wei, Doctor, +86 13467622617, 34438881@qq.com

    Zhu Wei

    Not yet recruiting

  • Dermatology Hospital, Southern Medical University

    Guangzhou, Guangdong, 510091

    Zhimiao Lin, Doctor, +86 13681438841, alvinlzm@126.com

    zhimiao Lin

    Not yet recruiting

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Liming Wu, Doctor, +86 13750837205, 18957118053@163.com

    Liming Wu

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase III Clinical Trial to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Children (2 Years Old ≤ Age < 12 Years Old) With Moderate to Severe Atopic Dermatitis (AD)

This study is a 2-part (parts A and B) study.The primary objective of the study is to evaluate the efficacy of 611 in Chinese Children with moderate to severe atopic dermatitis (AD).

Read the detailed description

This study comprises Part A and Part B. Part A is a PK study in pediatric participants aged ≥2 years to <6 years with moderate to severe AD; Part B is a Phase III confirmatory trial for pediatric participants aged ≥2 years to <12 years with moderate to severe AD.

The maximum study duration for part A is 30 weeks per participants, including a screening period of up to 6 weeks, a 18-week treatment period, and an 6-week follow-up period.

The maximum study duration for part B is 60 weeks per participants, including a screening period of up to 6 weeks, a 18-week Double blind treatment period, a 36-week maintenance treatment period, and an 6-week follow-up period.

Being tested
611, Matching placebo
Keywords
Dermatitis, Atopic
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

    Solution for injection, subcutaneous (SC)

  • 611Drug

    Solution for injection, subcutaneous (SC)

  • Matching placeboDrug

    Solution for injection, subcutaneous (SC)

Study groups in NCT07767253
Study groupRoleWhat they receive
Part A (Open-label PK study)ExperimentalAge cohort :≥2 years old to <6 years old
Receives: Drug: 611
Part B (Double-blind confirmatory study) 611ExperimentalThe results of part A will be used to guide the enrollment for participants aged ≥2 years to <6 years with AD for part B.
Receives: Drug: 611
Part B (Double-blind confirmatory study) placeboPlacebo comparatorNot described
Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: drug concentration.

    concentration of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) .

    Measured: Baseline, Week 24.

  2. Part B: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 18.

    The EASI score is 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 18.

  3. Part B: 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 18.

    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 18.

Secondary outcomes (15)

  1. Part A: Adverse events (AEs), measurement of vital signs, physical examination, electrocardiogram and laboratory tests at each visit.

    The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations, electrocardiogram, laboratory tests and, etc.

    Measured: Baseline, Week 24.

  2. Part A: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point.

    The EASI score is 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 24.

  3. Part A: 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.

    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 Week24.

  4. Part A: Number of Participants With EASI-50 (>=50% Improvement From Baseline).

    The EASI score is 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 24.

  5. Part A: Number of Participants With EASI-90 (>=90% Improvement From Baseline).

    The EASI score is 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 24.

  6. Part A: Number of Participants Who Achieved >=4 Points Points With Improvement From Baseline in Weekly Average of Daily pruritus Numerical Rating Scale (NRS) Score From Baseline.

    pruritus Numerical Rating Scale (NRS) is an assessment tool 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 you rate your 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 to Week 24.

  7. Part A: Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.

    Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%.

    Measured: Baseline to Week 24.

  8. Part A: Change in serum concentrations of Thymus and activation regulated chemokine (TARC), IgE, lactate dehydrogenase (LDH) , Change in whole blood eosinophil counts.

    Change in serum concentrations of TARC, IgE, LDH , Change in whole blood eosinophil counts.

    Measured: Baseline to Week 24.

  9. Part B: 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 18.

    The EASI score is 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.

  10. Part B: 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 18.

    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.

  11. Part B: Number of Participants With EASI-50 (>=50% Improvement From Baseline) .

    The EASI score is 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.

  12. Part B: Number of Participants With EASI-90 (>=90% Improvement From Baseline).

    The EASI score is 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.

  13. Part B: Number of Participants Who Achieved >=4 Points Points With Improvement From Baseline in Weekly Average of Daily pruritus Numerical Rating Scale (NRS) From Baseline.

    pruritus Numerical Rating Scale (NRS) is an assessment tool 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 you rate your 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 to Week 60.

  14. Part B: Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 18.

    TCS medication-free days is calculated as the number of days that a participant used neither TCS nor system rescue therapy divided by the study days of each period.

    Measured: Baseline to Week 18.

  15. Part B:Adverse events (AEs), measurement of vital signs, physical examination, electrocardiogram and laboratory tests at each visit.

    The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations, electrocardiogram, laboratory tests and, etc.

    Measured: Up to 60 Weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start22 Sep 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

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
Model description
Part A: Single Arm Part B: Parallel Group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07767253
Sponsor's protocol ID
SSGJ-611-PED-AD-III-02
Status last verified
Aug 2026
First submitted
7 Aug 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 5 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 18 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 9 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 5 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?

Part A: drug concentration. (time frame: Baseline, Week 24.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07767253.

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 9 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in