XTMAB-16 for Sarcoidosis
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Xentria, Inc.
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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
Eligibility Criteria
This trial is for patients with pulmonary sarcoidosis who completed the XTMAB-16-201 study. They should have finished either Week 12 or Week 24 assessments and must be on a stable steroid dose for at least two weeks before starting this extension study.Inclusion Criteria
I completed Week 12 or 24 assessments in the XTMAB-16-201 study.
I have been on a stable steroid dose for at least 2 weeks before joining this part of the study.
Participant Groups
The trial is testing the long-term safety and effectiveness of a drug called XTMAB-16 in treating pulmonary sarcoidosis, which may also affect other parts of the body. It's an open-label extension, meaning everyone knows they're getting XTMAB-16.
1Treatment groups
Experimental Treatment
Group I: XTMAB-16 TreatmentExperimental Treatment1 Intervention
Dose to be established in the XTMAB-16-201 Study.
XTMAB-16 is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as XTMAB-16 for:
- Pulmonary sarcoidosis (Orphan Drug Designation)
🇪🇺 Approved in European Union as XTMAB-16 for:
- Pulmonary sarcoidosis (Orphan Drug Designation)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Xentria Investigative SitePhiladelphia, PA
Xentria Investigative SiteDenver, CO
Xentria Investigative SiteChicago, IL
Xentria Investigative SiteGreenville, NC
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Who Is Running the Clinical Trial?
Xentria, Inc.Lead Sponsor