Phase 1b2 Study of XTMAB-16 Treatment for Pulmonary Sarcoidosis With or Without Other Organ Involvement

What this Trial Is About

This research aims to assess the drug XTMAB-16 in adults with pulmonary sarcoidosis, a condition involving lung inflammation. The study is a combined Phase 1b2 trial focusing on patients diagnosed at least six months prior, including those with or without additional organ involvement. It follows guidelines from leading respiratory societies and seeks to understand the drugs safety and effects while tapering corticosteroid use. Participants receive XTMAB-16 or a placebo through infusions at varying doses and schedules over two parts. In Part A, patients get doses every 2 or 4 weeks for 12 weeks, with four different dosing regimens including placebo. Part B continues treatment with the dose established in Part A for 24 weeks or placebo. Participants are asked to follow certain dietary restrictions and testing requirements during the study. Throughout the study, participants undergo monitoring for adverse events and steroid dose reductions, with evaluations lasting up to 34 weeks. Assessments include safety checks, lung function tests, and tracking corticosteroid use. The study measures include the rate of side effects, ability to reduce steroid doses, and maintenance of steroid reduction. Participants provide informed consent and receive ongoing support to comply with study procedures.

A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis