Systemic Sclerosis en Interstitial Lung Disease
Conditions
Interventions
A placebo arm is needed to allow for a true assessment of the effects of
MK-7240/ PRA023 on the rate of decline in FVC. In this study, the placebo arm
will be commercially available 0.9% normal sali
Sponsors
Prometheus Biosciences, Inc, a subsidiary of Merck & Co.,Inc.(Rahway,NJ,USA)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of systemic sclerosis with onset of disease or = 45% of predicted normal 5. Diffusing capacity of lung for carbon monoxide (DLCO) > or = 45% of predicted normal 6. Stable dosing of myocphenolate mofetil (MMF), methotrexate (MTX) or azathioprine, as well as corticosteroids 7. Able to provide written informed consent and understand and comply with the requirements of the study
Exclusion criteria
Exclusion criteria: 1. WOCBP and men with female partners of childbearing potential who are unwilling or unable to use tow highly effective methods of contraception to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of study drug 2. Airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension 3. Current clinical diagnosis of another inflammatory connective tissue disease 4. Any active infections, a serious infection within the past 3 months, or chronic bacterial infection 5. Current smoker or smoking within 6 months of screening 6. Subjects in the opinion of the investigator that are at an unacceptable risk for participation in the study 7. Subjects who meet the protocol criteria for important laboratory exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| x The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values x To compare the annual rate of change from Baseline in FVC, in mL, of MK-7240/PRA023 vs. placebo over 50 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare the change from Baseline in FVC in mL of MK7240/PRA023 vs. placebo at Week 50 • To compare the change from Baseline in high-resolution computer tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL) of MK-7240/PRA023 vs. placebo at Week 50 • To compare proportion of subjects with an improvement in the revised Composite Response Index in Systemic Sclerosis (CRISS) score of MK7240/PRA023 vs. placebo at Week 50 • To assess the change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) of MK-7240/PRA023 vs. placebo at Week 50 • To assess the change from Baseline in Living with Pulmonary Fibrosis (L-PF) patient-reported quality of life (QoL) outcome of MK7240/PRA023 vs. placebo at Week 50 x To assess the change in histology in skin biopsy in subjects who consented to the skin biopsy sub study For more information please refer to study endpoints page 35 of the protocol | — |
Countries
Netherlands
Outcome results
None listed