NCT05017480

A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China

A Double-blind, Multi-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of CBP-201 in Chinese Subjects With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Connect Biopharm LLC · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of CBP-201 in Chinese subjects with moderate to severe atopic dermatitis.

Detailed description

This study is a randomized, double-blind, multi-center, controlled study designed to assess the efficacy, safety and PK characteristics of CBP-201 in eligible subjects with moderate to severe AD. The study includes a screening period, a treatment period and a follow-up period. The treatment period is divided into two stages.

Conditions

• Moderate-to-severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	CBP-201	CBP-201 subcutaneous(SC) injection.
DRUG	Placebo	subcutaneous(SC) injection

Timeline

• Start date: 2021-08-31
• Primary completion: 2022-12-01
• Completion: 2023-09-28
• First posted: 2021-08-23
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

48 sites across 1 country: China

Regulatory

• FDA-regulated drug study