NCT06169397
An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Enrolling by Invitation
PHASE2Ages 18–80InterventionalTreatmentXentria, Inc.
~94 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:XTMAB-16
At a glance
Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration
Measured over Through study completion, an average of 4 years
Conditions
Where it's being run
11 sites across 9 statesEngland3
Colorado1
Illinois1
North Carolina1
Ohio1
Pennsylvania1
Czechia1
Poland1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Completion of XTMAB-16-201 study: completion of Week 12 (Part A) or Week 24 (Part B) assessments.
Participants from XTMAB-16-201 Part A and Part B should be on a stable steroid dose for at least 2 weeks prior to informed consent/Day 1 of XTMAB-16-202 (Day 1 should occur at the next scheduled dosing visit on the assigned dose frequency cohort of XTMAB 16 201 ± 2 weeks).
Exclusion
Evidence of treatment-related AEs requiring treatment discontinuation per XTMAB-16-201 protocol observed in XTMAB-16-201 study.
Evidence of treatment failure observed in XTMAB-16-201 study per protocol definition.
Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the study.
What this trial measures
- Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study durationThrough study completion, an average of 4 years
To evaluate the long-term safety and tolerability of XTMAB-16 in participants with pulmonary sarcoidosis with or without extra-pulmonary manifestations