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Sarilumab in Glucocorticoid-Dependent Sarcoidosis
NCT04008069Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2019
- Primary completion
- Jul 2022
- Countries
- 1
- Sponsor
- Stanford University
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- sarilumab
- Conditions
- sarcoidosis
01
Overview
Phase 2, randomised, double-blind trial of sarilumab in sarcoidosis (3 arms), sponsored by Stanford University. Primary endpoint: Number of Participants Without Sarcoidosis Flare. Started Sep 2019; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Open-Label Sarilumab
Pre-randomization phase where all patients receive Sarilumab.
Double-Blind Sarilumab
Post-randomization arm receiving Sarilumab.
Double-Blind Placebo
Post-randomization arm receiving Placebo.
03
Who it enrols
Patients with biopsy-proven active, glucocorticoid-dependent sarcoidosis (prednisone 10-60 mg/day) involving lungs, lymph nodes, or other organs. Excludes stage IV pulmonary sarcoidosis, cardiac/CNS sarcoidosis, and severe organ dysfunction.
04
Endpoints
Primary
Number of Participants Without Sarcoidosis Flare
Secondary
Change From Baseline in Forced Vital Capacity Percent Predicted
Change From Baseline in Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide Percent Predicted
Change in Pulmonary Function (FEV1) Percent Predicted
Change From Baseline in Extrapulmonary Physician Organ Severity Tool Scale Score
Change From Baseline in Physician Disease Activity Visual Analogue Scale
Change From Baseline in Patient Disease Activity Visual Analogue Scale
Change From Baseline in FACIT-F Score (Fatigue Scale)
Number of Tender and Swollen Joints Per 68/66 Joint Evaluation
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