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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: Completed Phase 2 study, sponsored by Swedish Orphan Biovitrum.
NCT03311854 is a Phase 2 study that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT03311854 record still lists
NCT03311854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Emapalumab is the first listed.
NCT03311854 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03311854's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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