A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD) - The ATHENA-SSc-ILD Study

Prometheus Biosciences Inc.0 个研究点目标入组 100 人开始时间: 2022年3月17日最近更新: 2023年8月28日

研究概览

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•1. Confirmed diagnosis of systemic sclerosis with onset of disease < or =5 years ago
•2. Diffuse cutaneous scleroderma
•3. Systemic sclerosis related to interstitial lung disease confirmed by HRCT
•4. FVC > 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1. WOCBP and men with female partners of childbearing potential who are unwilling or unable to use two 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

发起方