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)

Lead Sponsor

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

•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
•Is a current smoker or smoking within 6 months of screening
•Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study

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