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

Xentria

Status and phase: Invitation-only; Phase 2

Conditions: Pulmonary Sarcoidosis

Treatments: Drug: XTMAB-16

Study type: Interventional

Funder types: Industry

Identifiers

NCT06169397

XTMAB-16-202

Details and patient eligibility

About

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

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 1 patient group

XTMAB-16 Treatment

Experimental group

Description:

Dose to be established in the XTMAB-16-201 Study.

Treatment:

Drug: XTMAB-16