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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2029-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pulmonary Sarcoidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XTMAB-16 Treatment

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

Group Type EXPERIMENTAL

XTMAB-16

Intervention Type DRUG

XTMAB-16 infusion

Interventions

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XTMAB-16

XTMAB-16 infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No