An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- Xentria, Inc.
- Study ID
- NCT06169397
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- Pulmonary Sarcoidosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- XTMAB-16 — DRUGXTMAB-16 infusion
Study Details
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
Key Dates
- Start date
- Mar 1, 2024
- Status verified
- Jul 2025
- Primary completion
- Jan 31, 2029
- Completion
- Jan 31, 2029
Study Design
- Enrollment
- 94 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: XTMAB-16 TreatmentDose to be established in the XTMAB-16-201 Study.
Primary Outcome Measure
Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration [ Time Frame: Through study completion, an average of 4 years ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Xentria Investigative Site | Denver | Colorado | 80206 | - |
| Xentria Investigative Site | Chicago | Illinois | 60611 | - |
| Xentria Investigative Site | Greenville | North Carolina | 27858 | - |
| Xentria Investigative Site | Cincinnati | Ohio | 45267 | - |
| Xentria Investigative Site | Philadelphia | Pennsylvania | 19140 | - |
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