A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis

Inclusion criteria

• . 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.
• . Receiving treatment of 7.5 to 25 mg/day of oral prednisone, or equivalent, during the screening period and, at the determination of the investigator, is capable of undergoing the protocol specific corticosteroid taper regimen.
• . Receiving treatment with methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine for at least 3 months before Screening that has been at a stable dose for 4 weeks before Screening. All efforts should be made to maintain stable background therapy at the Screening dose through the intervention period at the Investigator's discretion.
• . PART A only: Willing to refrain from consumption of grapefruit or grapefruit juice \[pomelos, exotic citrus fruits, or grapefruit hybrids\] from screening visit until after the final dose.
• . Polymerase chain reaction (PCR) test or rapid antigen test negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening.