Pulmonary sarcoidosis MedDRA version: 20.0 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: ILARIS
Product Code: ACZ885
Pharmaceutical Form: Solution for injection
INN or Proposed INN: canakinumab
CAS Number: 914613-
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Disease duration of =1 year Clinically active disease demonstrated either by a biopsy (any organ) or by bronchoalveolar lavage, patients must also have all of the following criteria: - MMRC dyspnea scale =1 - Threshold FVC 50 - 90% of predicted - Evidence of parenchymal lung involvement by HRCT at screening or by historical radiological evidence - Male and female subjects ages 18 to 80 years of age weighting at least 50 kg 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: - Any conditions or significant medical problems which in the opinion of the investigator immunocompromises the patient and/ or places the patient at unacceptable risk for immunomodulatory therapy, such as: - Absolute neutrophil count (ANC) <LLN (1,500/µl) - Thrombocytopenia CTCAE v4.03 Grade 1: Platelets <LLN (75.0 x 109/L) - Any active or recurrent bacterial, fungal (with exception of onychomycosis) or viral infection - Presence of human immunodeficiency virus (HIV)infection, active hepatitis B or hepatitis C infections - Presence of active or latent tuberculosis (TB) established during screening - Clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty’s syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the effect of ACZ885 versus placebo on the clinical disease activity of sarcoidosis patients as measured by the change from baseline in the percent predicted forced vital capacity (FVC) ; Secondary Objective: - To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) [F-18]FDGPET in nodules (nodular uptake regions) - To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing (i.e., absolute FVC, FEV1, FEV1/FVC, FEV3,FEF25-75, FEV3/FVC, 1- (FEV3/FVC), TLC, RV, RV/TLC, DLco and postbronchodilator FEV1/reversibility) - To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis as measured by side-by-side comparison by blinded reviewers and HRCT scoring - To determine the effect of ACZ885 versus placebo on the 6- minute walk test (6MWT) distance of patients with sarcoidosis - To determine the effect of ACZ885 on additional [F-18]FDG-PET outcomes (i.e., SUVmean, SUVpeak and volume of the lesions) - To assess the safety and tolerability of ACZ885 in patients with sarcoidosis as measured by adverse events (AEs) ; Primary end point(s): Change from baseline in percent predicted forced vital capacity (FVC) ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 or/and 24 weeks; Secondary end point(s): - Percent change from initial scan in [F-18]FDG-PET - Lung function testing results(I i.e., absolute FVC, FEV1, FEV1/FVC, FEV3,FEF25-75, FEV3/FVC, 1- (FEV3/FVC), TLC, RV, RV/TLC, DLco and postbronchodilator FEV1/reversibility) -HRCT results compared to HRCT initial scan measured by blinded reviewers and HRCT scoring - 6MWT results compared to baseline - Percent change from initial scan in additional [F-18]FDG PET outcomes - Adverse events in patients taking ACZ885 compared to placebo | — |
Countries
Germany, Netherlands, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed