A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled, 3-Part Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Doses of TRB-061 in Healthy Participants and in Patients with Moderate-to-Severe Atopic Dermatitis (NCT06934252)

This trial aims to investigate the safety and efficacy of Multiple Subcutaneous Doses of TRB-061 in patients with moderate-to-severe Atopic Dermatitis. Participants will receive doses of study treatment for up to 6 months (24 months). This would include administering doses of study treatment (TRB-061 24mg or 50mg subcutaneous injections) or placebo every 4 weeks over 12 weeks in period 1. In period 2, another 4 doses of treatment with increased dose of 50mg, will be given over 12 weeks to all participants, including those who received placebo in period 1. Participants are expected to visit study clinic 16 times during trial.

Trial phase

IA/IB

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Johannes S Kern

Key inclusion data

Participants with confirmed diagnosis of AD with onset of symptoms for at least 1 year. Participant must have had inadequate response or intolerance to topical corticosteroids. Participants must be of adult male and females, aged 18 to 70 years (inclusive).