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

NCT06169397 · tracked via the Priya Life Science UK tracker

Sponsor

Xentria, Inc.

Phase

Phase 2

Started

2024-03-01

Last updated

2026-08-21

Condition(s) studied

Pulmonary Sarcoidosis

Investigational drug(s) / intervention(s)

XTMAB-16

XTMAB-16: XTMAB-16 infusion

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration — Through 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

Trial sites (11)

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06169397 on ClinicalTrials.gov ↗ ← All trials in the UK