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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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)
