Trials / Active Not Recruiting
Active Not RecruitingNCT06554847
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.
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 611 | subcutaneous injection |
| DRUG | Placebo | subcutaneous injection |
| DRUG | Topical corticosteroid | Topical |
Timeline
- Start date
- 2024-09-23
- Primary completion
- 2025-10-12
- Completion
- 2026-08-16
- First posted
- 2024-08-15
- Last updated
- 2025-07-14
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06554847. Inclusion in this directory is not an endorsement.