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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Pulmonary Sarcoidosis

Intervention / Treatment
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* Drug: XTMAB-16


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XTMAB-16 Treatment<br>Dose to be established in the XTMAB-16-201 Study. | Drug: XTMAB-16<br>* XTMAB-16 infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 as characterized by changes in quality of life measured by Steroid Toxicity 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 | 
| 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 | 
| 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 |