An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XTMAB-16.
- Who it may be relevant to
- Registry conditions: Pulmonary Sarcoidosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Czechia, Poland, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Detailed description
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
Interventions
- Drug XTMAB-16
XTMAB-16 infusion
Primary outcome measures
- 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 outcome measures (8)
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Xentria Investigative Site — Denver
- Xentria Investigative Site — Chicago
- Xentria Investigative Site — Greenville
- Xentria Investigative Site — Cincinnati
- Xentria Investigative Site — Philadelphia
United Kingdom · 4 centers
- University Hospitals Coventry and Warwickshire NHS Trust — Coventry
- King's College Hospital NHS Foundation Trust — London
- Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich
- NHS Tayside — Perth
Czechia · 1 center
- Xentria Investigative Site — Prague
Poland · 1 center
- Xentria Investigative Site — Bielsk Podlaski
Identifiers
NCT: NCT06169397 · XTMAB-16-202