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

Pulmonary Sarcoidosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06169397
• Other study ID #: XTMAB-16-202
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: January 2029

Study information

• Verified date: April 2024
• Source: Xentria, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 94
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Drug:
• XTMAB-16
XTMAB-16 infusion

Locations

Country	Name	City	State
United States	Xentria Investigative Site	Chicago	Illinois
United States	Xentria Investigative Site	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Xentria, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration		Through study completion, an average of 4 years
Secondary	Durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)		Through study completion, an average of 4 years
Secondary	Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung		Through study completion, an average of 4 years
Secondary	Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire General		Through study completion, an average of 4 years
Secondary	Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Leicester Cough Questionnaire		Through study completion, an average of 4 years
Secondary	Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Steroid Toxicity Questionnaire		Through study completion, an average of 4 years
Secondary	Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity)		Through study completion, an average of 4 years
Secondary	Immunogenicity (number of participants who test positive for anti drug antibodies and/or neutralizing antibodies) in the context of long-term dosing		Through study completion, an average of 4 years
Secondary	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		Through study completion, an average of 4 years