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Enrolling By InvitationPhase 2NCT06169397

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

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

Lead sponsor: Xentria, Inc.•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Xentria, Inc.

Age

18 - 80 years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 9, 2025Terms

Trial snapshot

StatusENROLLING_BY_INVITATION

PhasePHASE2

Enrollment94

Start dateMar 2024

Last updatedJul 9, 2025

Condition

Pulmonary Sarcoidosis

Locations shown

Xentria Investigative Site

Denver, Colorado

Xentria Investigative Site

Chicago, Illinois

Xentria Investigative Site

Greenville, North Carolina

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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