Systemic sclerosis associated with interstitial lung disease MedDRA version: 21.0 Level: LLT Classification code 10025109 Term: Lung involvement in systemic sclerosis System Organ Class: 100000004855
Conditions
Interventions
Product Code: PRA023
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tulisokibart
Current Sponsor code: PRA023
Other descriptive name: PRA023
Concentration unit: mg/ml
Sponsors
Prometheus Biosciences, Inc.
Eligibility
Sex/Gender
All
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 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
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 |
|---|---|
| Main Objective: • To assess the safety and tolerability of PRA023 in SSc-ILD • To compare the annual rate of change from Baseline in forced vital capacity (FVC), of PRA023 vs. placebo over 50 weeks;Secondary Objective: • To compare the change from Baseline in FVC at Week 50 • To compare the change from Baseline in high-resolution computer tomography (HRCT) at Week 50 • To compare the annual rate of change in percent predicted FVC • To compare proportion of subjects with an improvement in the American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS) score at Week 50;Primary end point(s): _ The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values _ To compare the annual rate of change from Baseline in FVC;Timepoint(s) of evaluation of this end point: Week 50 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): _To compare the change from Baseline in FVC _To compare the annual rate of change in percent predicted FVC _To compare the change from Baseline in HRCT _To compare proportion of subjects with an improvement of the ACR CRISS score;Timepoint(s) of evaluation of this end point: Week 50 | — |
Countries
Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Operations
Prometheus Biosciences, Inc.
Outcome results
None listed