The purpose of this study is to assess if ACZ885 will improve lung function in association with reduction of tissue inflammation in patients with chronic sarcoidosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Albany, New York, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Essen, Germany
Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry
To compare the effect of ACZ885 versus placebo in the change between baseline and week 24 in pulmonary function as measured by spirometry (Predicted Forced Vital Capacity).
Time frame: Baseline, Week 24
Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT
To determine the effect of ACZ885 on the change of pulmonary tissue inflammation as measured by SUVmax\[F-18\]FDG-PET/CT from baseline after 12 weeks of treatment compared to placebo.
Time frame: Baseline, Week 12
Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT
To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) \[F-18\]FDG-PET in nodules (nodular uptake regions) after 12 weeks of treatment, compared to placebo.
Time frame: Baseline, Week 12
Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT
To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) \[F-18\]FDG-PET in in the extrathoracic Region after 12 weeks of treatment, compared to placebo.
Time frame: Baseline, Week 12
Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)
To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline. Forced Expiratory Volume (FEV) in 1, 3, 6 seconds, predicted and forced expiratory flow 25-75%. Results expressed in change from baseline
Time frame: Baseline, week 24
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Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Nieuwegein, Netherlands
Novartis Investigative Site
Rotterdam, Netherlands
Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring
To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis at 24 weeks compared to initial HRCT scan as measured by side-by-side comparison by blinded reviewers and HRCT scoring. HRCT score : sum of total parameters scores, each measured in different lung zones (right upper lobe; left upper lobe; right middle lobe; right lower lobe; left lower lobe). The extent of the disease is assessed for each zone to the nearest 10% of parenchymal surface: 0 (no disease) to 10 (91-100% disease).
Time frame: Baseline, Week 24
Change From Baseline Distance Walked as Assessed by the 6-minute Walk Test
To determine the effect of ACZ885 versus placebo on the 6-minute walk test distance of patients with sarcoidosis at 12 and 24 weeks compared to baseline
Time frame: Baseline, Week 12, and Week 24
Change From Baseline of Additional [F-18]FDG-PET Outcomes
To determine the effect of ACZ885 on additional \[F-18\]FDG-PET outcomes after 12 weeks of treatment compared to placebo. SUVmean: Mean standard uptake value for activity in the focal region volume SUVpeak: Mean standardized uptake value of a sphere (a diamater of approximately 1.2cm - to produce a 1-cm3-volume spherical Region of Interest (ROI) that has the highest average SUV with the lesion volume
Time frame: Baseline, Week 12
Change From Baseline in Other Parameters of Pulmonary Function Testing : Diffusion Capacity of Lung for CO
To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline.
Time frame: Baseline, week 24
Change From Baseline in Other Parameters of Pulmonary Function Testing : Percent Predicted DLco, FEV1/FVC, FEV3/FVC, Percent Predicted Forced Expiratory Flow (FEF) 25-75, RV/TLC (Residual Volume /Total Lung Capacity)
To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline. Percent Predicted DLco (Diffusion Capacity of Lung for CO), FEV1/FVC, FEV3/FVC (forced expiratory volume in 1 or 3 seconds /forced vital capacity), percent Predicted FEF25-75, RV/TLC
Time frame: Baseline, week 24