Clinical trial NCT06169397: An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Pulmonary Sarcoidosis
Lead sponsor: Xentria, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)
timeFrame: Through study completion, an average of 4 years
measure: Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung
timeFrame: Through study completion, an average of 4 years
measure: Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire General
timeFrame: Through study completion, an average of 4 years
measure: Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Leicester Cough Questionnaire
timeFrame: Through study completion, an average of 4 years
measure: Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Steroid Toxicity Questionnaire
timeFrame: Through study completion, an average of 4 years
measure: Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity)
timeFrame: Through study completion, an average of 4 years
measure: Immunogenicity (number of participants who test positive for anti drug antibodies and/or neutralizing antibodies) in the context of long-term dosing
timeFrame: Through study completion, an average of 4 years
measure: 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
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Xentria Investigative Site
state: Colorado
city: Chicago
country: United States
facility: Xentria Investigative Site
state: Illinois
city: Greenville
country: United States
facility: Xentria Investigative Site
state: North Carolina
city: Philadelphia
country: United States
facility: Xentria Investigative Site
state: Pennsylvania
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: England
city: Perth
country: United Kingdom
facility: NHS Tayside
state: Scotland
Study officials:
References: