Clinical trial

A Long-term Multicenter 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

Name

XTMAB-16-202

Description

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

Trial arms

Trial start

2024-03-01

Estimated PCD

2029-01-01

Trial end

2029-01-01

Phase

Early phase I

Treatment

XTMAB-16

XTMAB-16 infusion

Arms:

XTMAB-16 Treatment

Size

Primary endpoint

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

Through study completion, an average of 4 years

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 94, 'type': 'ESTIMATED'}}

Updated at

2024-04-03

1 organization

1 product

1 indication

Organization

Xentria

Product

XTMAB-16

Indication

Sarcoidosis