Evaluating Safety and Effects of Intravenous BBT001 in Adults with Chronic Spontaneous Urticaria A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study

What this Trial Is About

Researchers are evaluating BBT001, a drug given intravenously, in adults with Chronic Spontaneous Urticaria CSU through a Phase IIa, randomized, triple-blind, placebo-controlled study. This research aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity of BBT001 in patients both new to biologic therapy and those with prior biologic treatment experience. The study includes several groups receiving multiple ascending doses of BBT001 at 450 mg or 900 mg or a placebo. Participants are divided into cohorts based on their prior exposure to biologic therapies biologic-naive and biologic-experienced patients. Treatment involves repeated intravenous doses, with some cohorts optional, and participants are randomized to receive either the active drug or placebo. Participants will be monitored for adverse events, changes in vital signs, blood tests, physical exams, and electrocardiogram results for up to 183 days after the first dose. Pharmacokinetic parameters such as drug concentration over time and immunogenicity through anti-drug antibody development will be measured at specified times. The study lasts until 2028, with primary outcome assessments completed by the end of 2027.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Participants With Chronic Spontaneous Urticaria (CSU)