Dermatitis, AtopicPhase 3NCT06554847
Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing 611 and Topical corticosteroid in people with Dermatitis, Atopic and Eczema, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 sites in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for 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, Eczema, Atopic
- What is being tested?
- 611 and Topical corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 3 sitesChina
- Study dates
- 23 Sep 2024to 18 Aug 2026
- 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
- 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.
- Moderate to Severe Atopic Dermatitis.
- Recent history of inadequate response to treatment with topical medications.
Who cannot join
- Participation in a prior 611 clinical study.
- Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months.
- Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study.
- Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study.
- Evidence of active acute or chronic hepatitis.
- History of malignancy within 5 years before the screening visit or currently.
- Pregnant or breastfeeding women, or women planning to become pregnant.
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
Trial locations and contacts
3 sites in 1 country.
China3 sites
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 31003
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200050
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) When Used In Combination With Topical Corticosteroid Treatment (TCS) in Participants With Moderate to Severe Atopic Dermatitis.
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
- Conditions
- Dermatitis, Atopic, Eczema, Atopic
- Being tested
- 611, Placebo, Topical corticosteroid
- 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
PlaceboDrug
subcutaneous injection
Topical corticosteroidDrug
Topical
| Study group | Role | What they receive |
|---|---|---|
| 611 interval 1+Topical Corticosteroid | Experimental | Participants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. Receives: Drug: 611; Drug: Topical corticosteroid |
| 611 interval 2+Topical Corticosteroid | Experimental | Participants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. Receives: Drug: 611; Drug: Topical corticosteroid |
| Placebo+Topical Corticosteroid | Placebo comparator | Participants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. Receives: Drug: Placebo; Drug: Topical corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)
Measured: Baseline to Week 16
Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.
Measured: Baseline to Week 16
Secondary outcomes (1)
Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start23 Sep 2024
- Primary completion20 Oct 2025
- Study completion18 Aug 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554847
- Sponsor's protocol ID
- SSGJ-611-AD-III-02
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2024
- Last updated
- 17 Sep 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 17 Sep 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) When Used In Combination With Topical Corticosteroid Treatment (TCS) in Participants With Moderate to Severe Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT06554847
- Acronym / sponsor ID
- SSGJ-611-AD-III-02
- Conditions
- Dermatitis, Atopic, Eczema, Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 15 Aug 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.
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 611 interval 1+Topical Corticosteroid | Experimental | Drug: 611, Drug: Topical corticosteroidParticipants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. |
| 611 interval 2+Topical Corticosteroid | Experimental | Drug: 611, Drug: Topical corticosteroidParticipants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. |
| Placebo+Topical Corticosteroid | Placebo comparator | Drug: Placebo, Drug: Topical corticosteroidParticipants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Moderate to Severe Atopic Dermatitis.
- Recent history of inadequate response to treatment with topical medications.
Key exclusion criteria (8 listed)
- Participation in a prior 611 clinical study.
- Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months.
- Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study.
- Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study.
- Evidence of active acute or chronic hepatitis.
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 interval 1+Topical Corticosteroid, 611 interval 2+Topical Corticosteroid |
| Placebosubcutaneous injection | Drug | Placebo+Topical Corticosteroid |
| Topical corticosteroidTopical | Drug | 611 interval 1+Topical Corticosteroid, 611 interval 2+Topical Corticosteroid, Placebo+Topical Corticosteroid |
Primary outcome
Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)
Time frame: Baseline to Week 16
Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.
Time frame: Baseline to Week 16
1 secondary outcome
Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16
Time frame: Baseline to Week 16
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 17 Sep 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.
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 and Topical corticosteroid in people with Dermatitis, Atopic and Eczema, 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 4 inclusion and 8 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 17 Sep 2026. 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?
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?
Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score) (time frame: Baseline to 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 17 Sep 2026.