Status:
ACTIVE_NOT_RECRUITING
Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Conditions:
Dermatitis, Atopic
Eczema, Atopic
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 16 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06554847
Start Date
September 23 2024
End Date
August 16 2026
Last Update
July 14 2025
Active Locations (3)
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1
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China, 200050
2
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 31003
3
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010