A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
ConditionPulmonary Sarcoidosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXentria, Inc.
About this trial
A phase 1b/2 study of XTMAB-16 in patients with pulmonary sarcoidosis
Eligibility criteria
Qualifiers
Participant between 18 to 80 years (inclusive) of age.
Weighs between 45 kg and 160 kg (99 to 353 lbs) at Screening.
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).
Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥ 1.
Disqualifiers
Pregnant or breastfeeding women or women who are planning to become pregnant during the study.
PART A ONLY: Participants > 65 years of age. (This exclusion criterion is only applicable for EU).
PART A ONLY: Known potentially significant fibrotic disease and/or active inflammation contained solely in the hilar region as shown by high-resolution computed tomography (HRCT), confirmed by a central reader. Participants with current active inflammation in the hilar region with concurrent inflammation outside the hilar region may be included.
PART A ONLY: Any prior TNFα inhibitor therapy.
Trial design
Treatments tested in this trial
- XTMAB-16 or Placebo
Treatment groups
94 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov