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NCT03311854 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)
A Phase 2 study, sponsored by Swedish Orphan Biovitrum.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03311854 is a Phase 2 study that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 14 participants.
The verdict
NCT03311854, a Phase 2 study, has completed, sponsored by Swedish Orphan Biovitrum.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD). Emapalumab is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in sJIA or AOSD participants developing MAS, presenting an inadequate response to high dose glucocorticoid treatment.
Interventions
- DRUG Emapalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2020-05-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03311854
The ClinicalTrials.gov registry entry for NCT03311854 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Swedish Orphan Biovitrum, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Emapalumab is the first listed.
NCT03311854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03311854 about?
NCT03311854 is a clinical study titled "A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)". Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD). Emapalumab is a monoclonal antibody neutralizing inte...
What is the current status of trial NCT03311854?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2018-02-20. Estimated completion is 2020-05-19.
What interventions are being tested in trial NCT03311854?
The interventions under investigation include: Emapalumab (DRUG).
Who is sponsoring clinical trial NCT03311854?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
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