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
Principal investigator
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.
* 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.
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