An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Research type
Research Study
Full title
A Long-term Multicenter Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement.
IRAS ID
1008862
Contact name
Tom Matthews
Contact email
Sponsor organisation
Xentria, Inc.
Research summary
Study XTMAB-16-202 is a long term extension study that will be run at approximately 38 sites in the United States, Europe and the United Kingdom. We are doing this study to test whether a new medication, XTMAB-16, can improve sarcoidosis. The study is planned to include up to 94 people who have successfully completed the protocol-required treatment period in a previous study XTMAB-16-201 (parent study).
The objective of this study is to evaluate the long-term safety of XTMAB-16 and how well it is tolerated in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations.
Participants who were in part A of the parent study (on active drug medication or placebo) and are enrolled on this long-term extension study before the selection of the recommended dose will receive study medicine at the same dose amount and frequency they were assigned. Once the recommended dose is determined, they will transition to the recommended dose and frequency as applicable. Participants that were in part B will continue receiving the same treatment dose amount and frequency from the parent study.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0422
Date of REC Opinion
30 Jan 2024
REC opinion
Further Information Favourable Opinion