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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis in Subjects
This is a randomized, double-blind, placebo-controlled clinical trial with 500 participants. In this study, the safety evaluation used the common toxic reaction criteria of the National Cancer Institute to evaluate the adverse events of the drugs, and the effectiveness evaluation used the eczema area and severity score and the overall investigator score to confirm the efficacy.
Details
| Lead sponsor | Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 500 |
| Start date | 2024-10-08 |
| Completion | 2026-06 |
Conditions
- Atopic Dermatitis
Interventions
- TQH2722 injection
- Placebo of TQH2722 injection
Primary outcomes
- Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI) — Baseline to 16 weeks after treatment
Percentage of participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI) - Subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline — Baseline to 16 weeks after treatment
Percentage of subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline.
Countries
China