Waikanae

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of TRB-061, a drug given by subcutaneous injection, in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). This Phase 1a/1b randomized, double-blind, placebo-controlled study includes multiple parts to assess single and multiple doses. The study may adjust the number of dosing groups in the first two parts based on ongoing results. In Part 1, healthy adults receive a single dose of TRB-061 or placebo, followed by 12 weeks of monitoring. In Part 2, healthy adults receive three doses every four weeks over eight weeks, with a 10-week follow-up. Part 3 involves participants with moderate-to-severe AD receiving four doses of TRB-061 or placebo over 12 weeks, followed by a follow-up period. After the main study, those on placebo may have the option to receive the active treatment. Participants will undergo regular safety assessments including medical history, physical exams, laboratory tests, and monitoring for adverse events from screening through follow-up. Researchers will measure the incidence of adverse events and serious adverse events across all parts of the study. The total participation duration varies by part but includes follow-up lasting up to 12 weeks after dosing to ensure safety and collect pharmacological data.