A Seamless, Adaptive Multiple-Ascending-Dose and Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations

Inclusion criteria

• . Participant between 18 and 80 years (inclusive) of age.
• . Weighs between 45 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 World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).
• . mMRC Dyspnea Scale of ≥1.
• . Baseline pre-BD ppFVC of ≥ 50% during screening window, and confirmed at the Baseline visit prior to enrollment and dosing.
• . Receiving corticosteroid treatment 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.
• . Radiographic evidence of disease in the lung parenchyma (at least Scadding stage II disease) without the presence of significant fibrosis.