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

July 8, 2025 updated by: Xentria, Inc.

A Long-term Multicenter 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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia, 140 59
        • Xentria Investigative Site
  • Poland
      • Bielsk Podlaski, Poland, 15-044
        • Xentria Investigative Site
  • United Kingdom
    • England
      • Coventry, England, United Kingdom, CV22DX
        • University Hospitals Coventry and Warwickshire NHS Trust
      • London, England, United Kingdom, SE59RS
        • King's College Hospital NHS Foundation Trust
      • Norwich, England, United Kingdom, OX3 7LE
        • Norfolk and Norwich University Hospitals Nhs Foundation Trust
    • Scotland
      • Perth, Scotland, United Kingdom, PH11NX
        • NHS Tayside
  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • Xentria Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Xentria Investigative Site
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Xentria Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Xentria Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Xentria Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XTMAB-16 Treatment
Dose to be established in the XTMAB-16-201 Study.
Drug: XTMAB-16
XTMAB-16 infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire General
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Leicester Cough Questionnaire
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Steroid Toxicity Questionnaire
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity)
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years
Immunogenicity (number of participants who test positive for anti drug antibodies and/or neutralizing antibodies) in the context of long-term dosing
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years
Long-term effect of XTAMB-16 on serum biomarkers important to cytokine pathway and granuloma formation (ACE, IL-6, sIL-2R, sTNFa, CRP, IL-1b, calcitriol) in sarcoidosis
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xentria, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XTMAB-16-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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