NCT05544591

Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis

A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase II Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to evaluate the efficacy and safety of 611 in chinese adults with moderate to severe atopic dermatitis.

Detailed description

The maximum study duration was 28 weeks per participants, including a screening period of up to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	611 Q2W	subcutaneous injection, 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 2 to Week 14, 7 cycles)
DRUG	611 Q4W	subcutaneous injection, 600mg (loading dose, Day1) + 300mg Q4W (maintenance dose, on week 4, 8, 12) + placebo Q4W (on week 2, 6, 10, 14)
DRUG	Matching placebo	subcutaneous injection, Q2W, from Week 2 to Week 14, 7 cycles

Timeline

• Start date: 2022-10-26
• Primary completion: 2023-07-10
• Completion: 2023-09-20
• First posted: 2022-09-16
• Last updated: 2024-02-01

Locations

5 sites across 1 country: China