Kent Town

Researchers are evaluating the efficacy, safety, and tolerability of BMS-986368 in adults with Multiple Sclerosis Spasticity. This Phase 2 randomized, double-blind, placebo-controlled study aims to assess three different doses of this oral FAAHMAGL inhibitor to better understand its impact on spasticity symptoms in participants diagnosed with MS who have experienced spasticity for at least six months. Participants will be randomly assigned to one of four groups receiving either one of three doses of BMS-986368 or a placebo. The medication is administered orally on specified days during the study period. The trial includes a treatment phase lasting six weeks, followed by safety monitoring up to 16 weeks to evaluate adverse events and treatment tolerability. During the study, participants will undergo assessments including the Total Numeric-transformed Modified Ashworth Scale for the most affected lower limb, Numeric Rating Scale for Spasticity, MS Spasticity Scale, Timed 25-Foot Walk, and Clinical Global Impression of Severity. Researchers will monitor plasma drug levels and adverse events, including suicidal ideation and withdrawal symptoms, throughout the trial. The study duration and follow-up span up to 16 weeks from treatment start.

This research focuses on participants who previously took part in Avalyn Pharma-sponsored studies involving inhaled antifibrotic agents, such as AP01, for progressive pulmonary fibrosis or idiopathic pulmonary fibrosis. The study aims to evaluate the long-term safety and tolerability of these inhaled antifibrotic medications, continuing from where the prior study ended. It is an open-label extension study allowing participants to continue treatment with AP01. All participants will receive 100 mg of inhaled pirfenidone solution AP01 twice daily delivered through the eFlow Nebulizer System. The study involves a screening and baseline visit, followed by an open-label treatment period where participants continue receiving AP01. After completing treatment, participants will have a follow-up phone call approximately two weeks later to conclude their involvement. During the study, participants will use a paper dosing diary to track adherence, and any unused medication will be returned for monitoring. Researchers will assess safety and tolerability over an average of six years, along with lung function changes, disease stabilization, and quality of life measures. The total duration extends up to the studys end date in 2031, with ongoing safety evaluations.