NCT04444752

A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Connect Biopharm LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a randomized, double-blind, placebo-controlled, dose regimen finding study to assess the efficacy, safety, and steady-state PK profile of CBP-201 administered to eligible adult subjects with moderate to severe atopic dermatitis compared to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 16 weeks and a follow-up period of 8 weeks.

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: 2020-07-17
• Primary completion: 2021-07-28
• Completion: 2021-09-22
• First posted: 2020-06-24
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

59 sites across 4 countries: United States, Australia, China, New Zealand

Regulatory

• FDA-regulated drug study