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)

A Phase 1/2A, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeat-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) 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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	UCB1381	UCB1381 will be administered intravenously (iv) or subcutaneously (sc) in different dosages in Part A and iv in Part B
DRUG	Placebo	Placebo will be administered iv or sc in Part A and iv in Part B to maintain the blinding.

Timeline

• Start date: 2022-03-07
• Primary completion: 2025-07-17
• Completion: 2025-09-19
• First posted: 2022-03-14
• Last updated: 2025-10-20

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study