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

• Status: Enrolling by invitation
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xentria, Inc.

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.