By InvitationPhase 2

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

United States94 participantsStarted 2024-03-01

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

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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. * Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the study.

What they're measuring

Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration

Timeframe: Through study completion, an average of 4 years

Trial details

NCT IDNCT06169397

SponsorXentria, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01

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