XTMAB-16: A New Drug to Reduce Steroid Use in Sarcoidosis

Trial Objectives

People with pulmonary sarcoidosis usually rely on corticosteroids to help manage symptoms. Researchers are investigating the safety of a new study drug called XTMAB-16 to see if it can help reduce corticosteroid use while treating the disease.

Sarcoidosis is a chronic inflammatory condition that affects many of the organ systems in the body. While corticosteroid treatments can help people with this condition manage their symptoms, treatments usually involve high doses or a long maintenance period where the steroids are administered for up to a year or more. This study involves two parts: Part A assesses the safety of XTMAB-16 and will determine the appropriate dose and frequency of the drug to be studying in Part B. Part B will assess XTMAB-16’s ability to help participants reduce corticosteroid use.

In Part A of this study, volunteers will be randomly selected to receive either XTMAB-16 or a placebo (a medication containing no active ingredient). 6 patients will be assigned to the XTMAB-16 group and 2 patients will be assigned to placebo group. The group assignments will be blinded. During clinic visits, volunteers will be asked to complete questionnaires and be evaluated for adverse health events.

In Part B of this study, volunteers will again be randomly selected to receive either XTMAB-16 or a placebo (a medication containing no active ingredient). Volunteers have an equal chance of being assigned to the XTMAB-16 group as they do to being assigned to the placebo group. The group assignments will be blinded. Clinic visits in this section of the study will involve lung testing and monitoring corticosteroid use levels to determine the effectiveness of the drug.

Who Can Participate

People with a diagnosis of pulmonary sarcoidosis, who are receiving oral prednisone treatment and have been on a clinically stable dose of oral corticosteroid for at least 4 weeks.

Age: 18-80 Gender: Any

Estimated Time Commitment

Part A: A screening period for up to 42 days, followed by 12 weeks of treatment, including up to 13 clinic visits. Part B: A screening period for up to 42 days, followed by 24 weeks of treatment, including up to 19 clinic visits. After completing either part, participants will have the option to join an extension study. They will be monitored for 6 weeks after their last dose of the medication for safety and immunogenicity assessments.