Dermatitis, AtopicPhase 1/2NCT06324812
Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis
A Phase 1/2 study testing Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 25 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects or their legal guardians must be able to understand and comply with the study procedures. and must participate voluntarily and sign the written informed consent.
- When signing the informed consent form (ICF), Part 1: 12 years old ≤ age < 18 years old, weight ≥ 30kg; Part 2: 6 years old ≤ age < 12 years old, weight ≥ 15kg.
- AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
- (Investigator's Global Assessment) IGA ≥ 3 at screening and baseline visits.
- (Eczema Area and Severity Index) EASI ≥16 at screening and baseline visits.
- Participants with >=10 percent (%) body surface area (BSA) of AD involvement at screening and baseline visits.
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- Baseline peak pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4.
- With documented recent history (within 1 year before the baseline visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable.
- Willing apply a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit and continue for the duration of the study.
- Potentially fertile subjects (such as women who have had their first period or men who have had sperm implantation) must use highly effective contraception throughout the study period and for at least 3 months after the last dose.
- Patient, either alone or with help of parents/legal guardians, as appropriate, must be able to understand and complete study-related questionnaires.
Who cannot join
- Presence of skin comorbidities that may interfere with study assessments.
- Presence of active endoparasitic infections; or suspected endoparasitic.
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- History of malignancy within 5 years before the baseline visit.
- Participants who had a severe infection.
- Known or suspected history of immunosuppression.
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- 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 subject's safety and/or prevent the subject from completing the study.
- Treatment with topical drugs within 2 weeks before baseline; or systemic corticosteroids or immunosuppressive drugs within 4 weeks or 5 half-lives (whichever is longer) before baseline.
- Have been vaccinated with live (attenuated) vaccine within 4 weeks before baseline.
- The lab abnormalities at screening or baseline and not suitable for inclusion in the study judged by investigator.
- Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- History of alcohol or drug abuse within 6 months before baseline.
- History of hypersensitivity to 611 or their excipients.
- Have been participated in other clinical trials and used any experimental drugs within 8 weeks before baseline.
- Planned major surgical procedure during the patient's participation in this study.
- Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
- Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib/II Study to Evaluate the Safety, Pharmacokinetic and Efficacy of Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) in Chinese Children and Adolescents (6 Years Old ≤ Age <18 Years Old) With Moderate to Severe Atopic Dermatitis
The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis.
- Conditions
- Dermatitis, Atopic
- Being tested
- Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611)Drug
subcutaneous injection，611 450/600mg (loading dose) + 300mg once every 2 weeks/4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 611 | Experimental | subcutaneous injection, 611 450/600mg (loading dose) + 300mg once every 2 weeks/4 weeks Receives: Drug: Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: From baseline to week 24
Minimum concentration (Cmin)
Minimum concentration (Cmin) of 611
Measured: From baseline to week 24
Secondary outcomes (10)
Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score 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: From baseline to week 24
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
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: From baseline to week 24
Number of Participants with Eczema Area and Severity Index (EASI) - 50 Response (>= 50% Improvement in Score 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: From baseline to week 24
Number of Participants with Eczema Area and Severity Index (EASI) - 90 Response (>= 90% Improvement in Score 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: From baseline to week 24
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: From baseline to week 24
Percentage Change From Baseline in EASI Score
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: From baseline to week 24
Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement
BSA affected by AD was assessed for each section of the body and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections，with the higher scores reflecting the worse severity of AD.
Measured: From baseline to week 24
Change From Baseline in Weekly Average of Pruritus NRS
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: From baseline to week 24
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
CDLQI was a validated 10 question tool to measure the impact of skin disease on the quality of life (QOL) in children by assessing how much the skin problem has affected the participant over the past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (maximum = 30, minimum = 0). Higher the score, the greater the impact on QOL.
Measured: From baseline to week 24
Change From Baseline in Patient Oriented Eczema Measure (POEM)
POEM was a 7-item, validated questionnaire used to assess disease symptoms in children and adults. The format was a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on frequency of these disease symptoms during the past week (ie, 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days) with a scoring system of 0 to 28; the total score reflected the disease-related morbidity.
Measured: From baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start10 Jul 2024
- Primary completion25 May 2026
- Study completion25 May 2026
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Ma, MD, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324812
- Sponsor's protocol ID
- SSGJ-611-PED-AD-Ib/II-01
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study to Evaluate the Safety, Pharmacokinetic and Efficacy of Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) in Chinese Children and Adolescents (6 Years Old ≤ Age <18 Years Old) With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06324812
- Acronym / sponsor ID
- SSGJ-611-PED-AD-Ib/II-01
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 22 Mar 2024 (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 safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 611 | Experimental | Drug: Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611)subcutaneous injection, 611 450/600mg (loading dose) + 300mg once every 2 weeks/4 weeks |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Subjects or their legal guardians must be able to understand and comply with the study procedures. and must participate voluntarily and sign the written informed consent.
- When signing the informed consent form (ICF), Part 1: 12 years old ≤ age < 18 years old, weight ≥ 30kg; Part 2: 6 years old ≤ age < 12 years old, weight ≥ 15kg.
- AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
- (Investigator's Global Assessment) IGA ≥ 3 at screening and baseline visits.
- (Eczema Area and Severity Index) EASI ≥16 at screening and baseline visits.
Key exclusion criteria (18 listed)
- Presence of skin comorbidities that may interfere with study assessments.
- Presence of active endoparasitic infections; or suspected endoparasitic.
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- History of malignancy within 5 years before the baseline visit.
- Participants who had a severe infection.
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 |
|---|---|---|
| Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611)subcutaneous injection，611 450/600mg (loading dose) + 300mg once every 2 weeks/4 weeks | Drug | 611 |
Primary outcome
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
Time frame: From baseline to week 24
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.
Minimum concentration (Cmin)
Time frame: From baseline to week 24
Minimum concentration (Cmin) of 611
10 secondary outcomes
Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline)
Time frame: From baseline to week 24
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
Time frame: From baseline to week 24
Number of Participants with Eczema Area and Severity Index (EASI) - 50 Response (>= 50% Improvement in Score From Baseline)
Time frame: From baseline to week 24
Number of Participants with Eczema Area and Severity Index (EASI) - 90 Response (>= 90% Improvement in Score From Baseline)
Time frame: From baseline to week 24
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: From baseline to week 24
Percentage Change From Baseline in EASI Score
Time frame: From baseline to week 24
Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement
Time frame: From baseline to week 24
Change From Baseline in Weekly Average of Pruritus NRS
Time frame: From baseline to week 24
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
Time frame: From baseline to week 24
Change From Baseline in Patient Oriented Eczema Measure (POEM)
Time frame: From baseline to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lin Ma, MD principal investigator
Beijing Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) 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 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: finished, as of the sponsor's last update on 1 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit. (time frame: From baseline to week 24). 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 1 Jul 2026.