NCT04643457

A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis

A Phase I/IIA, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeated-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) Study to Investigate the Safety, Pharmacokinetics, and Efficacy of UCB9741 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: 107 (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 UCB9741 administered by intravenous infusion or subcutaneous injection to healthy study participants and following repeat dosing at a single dose level in study participants with atopic dermatitis. Furthermore, the clinical efficacy outcome in study participants with atopic dermatitis after administration of UCB9741 by intravenous infusion will be investigated.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	UCB9741	\- Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.
DRUG	Intravenous Placebo	\- Pharmaceutical form: Solution Participants will receive Placebo to maintain the blinding during the Treatment Period.
DRUG	Subcutaneous Placebo	Pharmaceutical form: Solution Participants will receive subcutaneous Placebo to maintain the blinding during the Treatment Period.

Timeline

• Start date: 2020-11-27
• Primary completion: 2024-04-23
• Completion: 2024-06-06
• First posted: 2020-11-25
• Last updated: 2026-04-06

Locations

10 sites across 4 countries: Bulgaria, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study