NCT04773678

Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Efficacy and Safety Study of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 322 (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 of two dose levels of CBP-201 in patients with moderate to severe persistent asthma with Type 2 inflammation.

Detailed description

This is a multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy and safety of two dose levels of CBP-201 administered to eligible patients with moderate to severe persistent asthma with Type 2 inflammation compared to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks.

Conditions

• Moderate to Severe Persistent Asthma

Interventions

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

Timeline

• Start date: 2021-05-11
• Primary completion: 2023-08-05
• Completion: 2023-09-28
• First posted: 2021-02-26
• Last updated: 2024-03-29

Locations

76 sites across 5 countries: United States, China, Hungary, Poland, South Korea

Regulatory

• FDA-regulated drug study