A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Active Pulmonary Sarcoidosis

Merck Sharp & Dohme LLC

Summary

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.

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * 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 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of cancer and is disease free for \<5 years * Has cardiac, o…

Interventions

Drug
Tulisokibart
Subcutaneous (SC) administration
Other
Placebo
SC administration
Drug
Background prednisone therapy
Oral administration

Location

Care Access Research Llc ( Site 2725)
Shreveport, Louisiana
318-209-3290

A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Active Pulmonary Sarcoidosis

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions