Brea

Researchers are evaluating the safety, tolerability, pharmacodynamics, and effectiveness of multiple increasing doses of a drug called CNP-106 in adults aged 18 to 75 with generalized myasthenia gravis. This is a Phase 1b/2a first-in-human clinical trial designed to gather important data about this treatment over a total study period of 222 days, which includes up to 42 days for screening and 180 study days. Participants must have specific clinical classifications and antibody positivity related to myasthenia gravis to be eligible. The study compares CNP-106, which contains an antigenic AChR Peptide Pool dispersed within a polymer matrix, against a placebo. The dosing involves multiple ascending doses, and participants are assigned to either the active drug or placebo groups. The trial is double-blind and placebo-controlled to ensure unbiased results. The intervention involves administration of CNP-106 or placebo particles sized 400-800 nm within a polymer matrix. Participants will undergo screening for up to 42 days before starting the 180-day treatment period. Throughout the study, various assessments will be conducted, including monitoring the frequency of adverse events and serious adverse events through day 180. Researchers will also evaluate pharmacodynamics and efficacy measures. Safety, tolerability, and treatment effects will be closely monitored, and participants will be followed for the entire duration of the study to assess outcomes and any potential side effects.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 study compares ruxolitinib cream to a vehicle cream, aiming to see if the treatment helps clear HS symptoms better than a non-active cream. The study focuses on participants with mild to moderate HS who have had the condition for at least six months. Participants will apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily to the affected areas. The study is double-blind and randomized, meaning neither the participants nor the researchers know who receives the active or vehicle cream during the treatment period. Participants must avoid using antibiotics or topical antiseptics on HS areas during the study and extension periods. Throughout the study, participants will be monitored to evaluate the proportion achieving a clinical response, specifically a 75% improvement in HS symptoms by week 16. Safety and treatment effects will be assessed through regular visits, and participants will be observed for any side effects or changes in their condition. The study's total duration includes the treatment and extension phases, with careful adherence to treatment application and restrictions to ensure accurate results.