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

Enrolling by invitation · Phase 2

Conditions studied: Pulmonary Sarcoidosis

In brief

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

Key facts

Study ID

NCT06169397

Run by

Xentria, Inc.

People needed

94

Starts

2024-03-01

Expected to finish

2026-11-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Xentria Investigative Site — Denver, Colorado, United States
• Xentria Investigative Site — Chicago, Illinois, United States
• Xentria Investigative Site — Greenville, North Carolina, United States
• Xentria Investigative Site — Cincinnati, Ohio, United States
• Xentria Investigative Site — Philadelphia, Pennsylvania, United States
• Xentria Investigative Site — Prague, Czechia
• Xentria Investigative Site — Bielsk Podlaski, Poland
• University Hospitals Coventry and Warwickshire NHS Trust — Coventry, England, United Kingdom
• King's College Hospital NHS Foundation Trust — London, England, United Kingdom
• Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich, England, United Kingdom
• NHS Tayside — Perth, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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