Study detail
RecruitingPhase 1
A Seamless, Phase 1b/2 Multiple Ascending Dose/Proof of Concept Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Xentria, Inc.
Summary
A phase 1b/2 study of XTMAB-16 in patients with pulmonary sarcoidosis
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: 1. Participant between 18 to 80 years (inclusive) of age. 2. Weighs between 45 kg and 160 kg (99 to 353 lbs) at Screening. 3. Diagnosis of pulmonary sarcoidosis (at least 6 months before Screening) using the 2020 American Thoracic Society (ATS) Clinical Practice Guideline (Crouser et al, 2020), the European Respiratory Society (ERS) or the WASOG criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted). 4. Modified Medical Research Conference (mMRC) Dyspnea Scale of…
Interventions
- DrugXTMAB-16 or Placebo
Infusion
Locations (34)
- Xentria Investigative SiteBirmingham, Alabama
- Xentria Investigative SiteDenver, Colorado
- Xentria Investigative SiteJacksonville, Florida
- Xentria Investigative SiteChicago, Illinois
- Xentria Investigative SiteChicago, Illinois
- Xentria Investigative SiteIowa City, Iowa