Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

Prior treatment

• Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study

Other illness

• Has an airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension
• Has current clinical diagnosis of another inflammatory connective tissue disease
• Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection

Lab values

• Meets the protocol criteria for important laboratory exclusion criteria

Other

• Is a current smoker or smoking within 6 months of screening

• Has confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
• Has diffuse cutaneous scleroderma
• Has systemic sclerosis related interstitial lung disease confirmed by HRCT
• FVC ≥ 45% of predicted normal
• Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal
• If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) OR azathioprine, and corticosteroids
• Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptable contraceptive method or sexually abstinent
• Able to provide written informed consent and understand and comply with the requirements of the study