NCT06554847CompletedPhase 3
Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
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.
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 417 (actual)
- First submitted
- 12 Aug 2024
- Start date
- 23 Sept 2024
- Primary completion date
- 20 Oct 2025
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06554847
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 417
- From 23 Sept 2024 to the primary completion date, 20 Oct 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
Other
- Pregnant or breastfeeding women, or women planning to become pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Shanghai Dermatology Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.