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Enrolling by Invitation

NCT Number: NCT06169397

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

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Key information

Conditions

Pulmonary Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Respiratory Tract Diseases Sarcoidosis Sarcoidosis, Pulmonary

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xentria Investigative Site, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XTMAB-16

Drug

XTMAB-16 infusion

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Xentria, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 13, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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