NCT06216392

Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 Injection in Patients With Moderate to Severe Atopic Dermatitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	GR1802 injection	150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
BIOLOGICAL	placebo	0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-01
• Completion: 2026-01-01
• First posted: 2024-01-22
• Last updated: 2024-01-22

Locations

1 site across 1 country: China