Researchers are looking for new ways to treat active pulmonary sarcoidosis (PS).
This trial will help researchers learn if a trial medicine called tulisokibart can treat symptoms of active PS. The goal of this trial is to learn if tulisokibart works better than placebo to increase the length of time until PS gets worse.
Has a diagnosis of sarcoidosis of ≥6 months before Screening confirmed by tissue biopsy
Has lung parenchymal involvement consistent with pulmonary sarcoidosis (PS) by chest X-ray or chest high-resolution computed tomography (HRCT) either via historical evidence or at Screening
Has active PS within 3 months before Screening
Has a history of cancer and is disease free for <5 years
Has cardiac, ocular, neurosarcoidosis, or other manifestations of sarcoidosis that requires systemic treatment that may interfere with protocol specifications, or has a clinically significant electrocardiogram abnormality that requires evaluation or intervention
Is receiving treatment for pulmonary hypertension
Has a history of fungal respiratory infection within 12 months before screening without documentation of completed treatment
Parallel
Tulisokibart
DrugSubcutaneous (SC) administration
Placebo
Other interventionSC administration
Background prednisone therapy
DrugOral administration
Time to First Worsening of Pulmonary Sarcoidosis (PS)
Worsening of PS is based on clinical judgment of worsening PS, along with pulmonary function tests and/or impaired or unacceptable loss of quality of life as measured by the King's Sarcoidosis Questionnaire (KSQ)-lung score. The time to first worsening of PS will be reported.
Number of Participants Experiencing Worsening of PS
Worsening of PS is based on clinical judgment of worsening PS, along with pulmonary function tests and/or impaired or unacceptable loss of quality of life as measured by the KSQ-lung score. The number of participants with worsening of PS will be reported.
Number of Participants With One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more adverse events will be reported.
Number of Participants Who Discontinue Study Drug Due to One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study drug due to one or more AEs will be reported.
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This trial is not recruiting at the moment. You can still explore other options:
