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Active Not Recruiting NCT06169397

An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis

Conditions: Pulmonary Sarcoidosis

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 31
Sponsor: Xentria, Inc.

Location: Xentria Investigative Site Denver Colorado

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 Criteria: 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 Criteria: 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06169397). StuddyBuddy aggregates publicly available trial information.