A phase 1b/2 study of XTMAB-16 in patients with pulmonary sarcoidosis
Research type
Research Study
Full title
A seamless, phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations.
IRAS ID
1007302
Contact name
Marwane Payet
Contact email
Sponsor organisation
Xentria, Inc.
Eudract number
0000-000000-00
Clinicaltrials.gov Identifier
To be registered
Research summary
Study XTMAB-16-201 is a two-part clinical 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. Adults with lung sarcoidosis are suitable for entry whether they have additional areas of
the body affected by sarcoidosis or not.
The first part of this study (Part A) will test four different doses. Participants who are suitable and have agreed to enter the trial will receive XTMAB-16 or placebo (a dummy drug that looks like XTMAB-16 but with no effect on sarcoidosis). Neither the participants nor the doctors will know which treatment has been given to each patient. The treatments will require visits to the hospital every 2 weeks for 12 weeks. After the treatments are finished, participants will be checked for another 8 weeks at the hospital or be given the opportunity to participate in another study of XTMAB-16.
The aim of this part of the study is to test the safety of XTMAB-16 in participants with sarcoidosis affecting
the lungs and to find the best dose of XTMAB-16.
In the second part of this study (Part B), the best dose of XTMAB-16 chosen from Part A is compared against
placebo in 62 patients. The treatment period of this portion of the study is 24 weeks.
Depending on the results of Part A, the participant will come to clinic every 2 or 4 weeks. After completion of the study, participants will be monitored for 10 weeks or be given the opportunity to participant in another study of XTMAB-16.
The aim of this study is to examine how well XTAMB-16 helps improve sarcoidosis by measuring the
participants’ use of oral corticosteroids over the course of the treatment period.
In both portion of the trial, blood tests will be completed in order to determine the correct dose of
XTMAB-16 study how XTMAB-16 is broken down in the body and study how XTMAB-16 affects
inflammatory markers important to sarcoidosis in the bloodREC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0190
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion