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

Active Not RecruitingPhase 2

Sponsor: Xentria, Inc.

Conditions: Pulmonary Sarcoidosis

Interventions: XTMAB-16

Countries: United States, Czechia, Poland, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (11)

Denver, Colorado, United States
Chicago, Illinois, United States
Greenville, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Prague, Czechia
Bielsk Podlaski, Poland
Coventry, England, United Kingdom
London, England, United Kingdom
Norwich, England, United Kingdom
Perth, Scotland, United Kingdom