Status:
ENROLLING_BY_INVITATION
An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Lead Sponsor:
Xentria, Inc.
Conditions:
Pulmonary Sarcoidosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- Participants are eligible to be included in the study if the following criteria apply:
- 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
- Participants are excluded from the study if any of the following criteria apply:
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06169397
Start Date
March 1 2024
End Date
January 1 2029
Last Update
July 9 2025
Active Locations (11)
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1
Xentria Investigative Site
Denver, Colorado, United States, 80206
2
Xentria Investigative Site
Chicago, Illinois, United States, 60611
3
Xentria Investigative Site
Greenville, North Carolina, United States, 27858
4
Xentria Investigative Site
Cincinnati, Ohio, United States, 45267