NCT05614817

CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis

A Randomized, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of CBP-201 Monotherapy in Patients With Moderate-To-Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Connect Biopharm LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, randomized, double-blinded, placebo-controlled trial in patients, ≥12 years of age who weigh ≥40 kg, and are diagnosed with moderate-to-severe AD.

Detailed description

This study is comprised of a 2- to 6-week (Day-45 to Day 1) Screening Period, a 16-week randomized, double-blind Treatment Period 1, a 36-week Treatment Period 2, and an 8-week follow-up after the last dose of study drug. Therefore, participants will be enrolled in the trial for a maximum of 66 weeks.

Conditions

• Atopic Dermatitis

Interventions

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

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-08-01
• Completion: 2025-07-01
• First posted: 2022-11-14
• Last updated: 2023-03-21

Regulatory

• FDA-regulated drug study