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

Phase 2

• Conditions: Pulmonary Sarcoidosis
• Interventions: Drug: XTMAB-16

• Registration Number: NCT06169397
• Lead Sponsor: Xentria, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-13
• Study Start: 2024-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XTMAB-16 Treatment	XTMAB-16	Dose to be established in the XTMAB-16-201 Study.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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
Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity)	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	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	Through study completion, an average of 4 years

Trial Locations

Locations (4)

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, England, United Kingdom

Xentria Investigative Site; 🇺🇸 Philadelphia, Pennsylvania, United States

King's College Hospital NHS Foundation Trust; 🇬🇧 London, England, United Kingdom

NHS Tayside; 🇬🇧 Perth, Scotland, United Kingdom