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Clinical Trials in Poland / NCT06169397
Active, not recruiting Phase 2

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

NCT06169397 · tracked via the Priya Life Science Poland 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
No
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)

FacilityCityRegionStatus
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

More Xentria, Inc. trials in Poland

Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations Active, not recruiting

Other trials for the same condition

Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations Active, not recruiting
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 Poland