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Namilumab in Chronic Pulmonary Sarcoidosis
NCT05314517Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2022
- Primary completion
- Oct 2024
- Countries
- 7
- Sponsor
- Kinevant Sciences
- Modality
- Monoclonal Antibodies
- Drugs
- namilumab
- Conditions
- pulmonary sarcoidosis
01
Overview
Phase 2, randomised, double-blind trial in pulmonary sarcoidosis comparing Namilumab with Placebo (2 arms). Primary endpoint: Percentage of Participants With a Rescue Event During the DB Period at Week 26. Started Aug 2022; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Namilumab
Namilumab SC every 4 weeks
Placebo
Placebo SC every 4 weeks
03
Who it enrols
Adults with active chronic pulmonary sarcoidosis (>6 months) confirmed histologically, with HRCT and dyspnea, on tapering corticosteroids or having failed/intolerant to immunosuppressive therapies. Excludes >20% fibrosis.
04
Endpoints
Primary
Percentage of Participants With a Rescue Event During the DB Period
Secondary
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC)
Time to the First Rescue Event During the DB Period
Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event
Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
05
Results
Not all primary endpoints met
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