Dermatitis, AtopicPhase 3NCT06173284
Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults 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 4 sites in China.
Trial summary
The primary objective of the study was to evaluate the efficacy of 611 in Chinese adults 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
- 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
- 519 participants
- Where
- 4 sitesChina
- Study dates
- 22 Jan 2024to 20 Nov 2025
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
- Male or female adults ages 18 to 75 years old when signing the informed consent.
- AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
- Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the screening and baseline visits.
- Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits.
- Participants with >=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits.
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- Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=4.
- Recent history (within 12 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).
- Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit.
- Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.
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, except completely treated in situ carcinoma of the cervix at least 1 year, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin at least 1 year.
- Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent infections, per investigator judgment.
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- Active TB, 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 such as corticosteroids, topical calcineurin inhibitors, PDE inhibitors, or Janus kinase (JAK) inhibitors within 2 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 vaccinated with live (attenuated) vaccine within 2 months before baseline or planned during the study period;
- Have used any investigational drug/treatment within 12 weeks before baseline;
- Planned or anticipated major surgical procedure during the patient's participation in this study.
- Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.
- Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Jinhua, Zhejiang, 322000
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330200
About this study
Official title: A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis
The primary objective of the study was to evaluate the efficacy of 611 in Chinese adults 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 52-week 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
subcutaneous injection
Matching placeboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 611 | Experimental | Induction treatment period : subcutaneous injection, 611 600mg (loading dose, week 0) + 300mg Q2W (from Week 2 to Week 14, 7 cycles) Maintenance treatment period : subcutaneous injection, 611 300mg Q2W or Q4W Receives: Drug: 611 |
| Placebo | Placebo comparator | Induction treatment period : subcutaneous injection, placebo Q2W (from Week 0 to Week 14, 7 cycles) Maintenance treatment period : subcutaneous injection, 611 600mg (loading dose, week 16) + 300mg Q2W or Q4W 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，Week 16
Secondary outcomes (14)
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 to 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 to Week 60
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: Baseline to Week 60
Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) 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: Baseline to Week 60
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: Baseline to Week 60
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI was a validated questionnaire used to measure the impact of AD disease symptoms and treatment on health-related quality of life (QOL). DLQI consisting of a set of 10 questions which assess QOL over the past week. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.
Measured: Baseline to Week 60
Change From Baseline in Patient Oriented Eczema Measure (POEM)
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.
Measured: Baseline to Week 60
Percentage of patients having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline 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: Baseline to Week 52
Percentage of patients having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52
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 52
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
Minimum concentration (Cmin)
Minimum concentration (Cmin) of 611
Measured: Baseline to Week 60
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 was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%.
Measured: Baseline to Week 60.
Change in serum concentrations of Pharmacodynamics indicators.
Pharmacodynamics indicators.
Measured: Baseline to Week 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start22 Jan 2024
- Primary completion26 Sep 2025
- Study completion20 Nov 2025
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
- 519 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173284
- Sponsor's protocol ID
- SSGJ-611-AD-III-01
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2023
- Last updated
- 15 Jan 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06173284
- Acronym / sponsor ID
- SSGJ-611-AD-III-01
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 15 Dec 2023 (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 adults 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 52-week 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: 611Induction treatment period : subcutaneous injection, 611 600mg (loading dose, week 0) + 300mg Q2W (from Week 2 to Week 14, 7 cycles) Maintenance treatment period : subcutaneous injection, 611 300mg Q2W or Q4W |
| Placebo | Placebo comparator | Drug: Matching placeboInduction treatment period : subcutaneous injection, placebo Q2W (from Week 0 to Week 14, 7 cycles) Maintenance treatment period : subcutaneous injection, 611 600mg (loading dose, week 16) + 300mg Q2W or Q4W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
- Male or female adults ages 18 to 75 years old when signing the informed consent.
- AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
- Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the screening and baseline visits.
- Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the 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, except completely treated in situ carcinoma of the cervix at least 1 year, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin at least 1 year.
- Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
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 |
|---|---|---|
| 611subcutaneous injection | Drug | 611 |
| Matching placebosubcutaneous injection | 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，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.
14 secondary outcomes
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 to 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 to Week 60
Percentage Change From Baseline in EASI Score
Time frame: Baseline to Week 60
Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement
Time frame: Baseline to Week 60
Change From Baseline in Weekly Average of Pruritus NRS
Time frame: Baseline to Week 60
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Time frame: Baseline to Week 60
Change From Baseline in Patient Oriented Eczema Measure (POEM)
Time frame: Baseline to Week 60
Percentage of patients having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline EASI score)
Time frame: Baseline to Week 52
Percentage of patients having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52
Time frame: Baseline to Week 52
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
Time frame: Up to 60 Weeks
Minimum concentration (Cmin)
Time frame: Baseline to Week 60
Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.
Time frame: Baseline to Week 60.
Change in serum concentrations of Pharmacodynamics indicators.
Time frame: Baseline to Week 60.
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 15 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 4 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 10 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
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 15 Jan 2026.