drugset / Trial / NCT05277571

A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)

NCT05277571 ↗

Phase 1/2 Completed 109 enrolled UCB Biopharma SRL
RandomizedParallel-groupQuadruple-blindBasic science

Summary

The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis.

Timeline

Start
2022-03-07
Primary completion
2025-07-17
Completion
2025-09-19

Outcome

Met primary endpoint

release “Donzakimig in atopic dermatitis (phase 2a) met primary endpoint - portfolio prioritization towards other opportunities;” ucb.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Donzakimig Monoclonal antibody — Intravenous

Indications