A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFNγ) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH)
Phase of Trial: Phase II
Latest Information Update: 28 Mar 2018
At a glance
- Drugs Emapalumab (Primary)
- Indications Haemophagocytic lymphohistiocytosis
- Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
- Sponsors NovImmune SA
- 22 Mar 2018 Planned number of patients changed from 5 to 10.
- 22 Mar 2018 Planned End Date changed from 1 Jul 2019 to 1 May 2021.
- 22 Mar 2018 Planned primary completion date changed from 1 Jul 2019 to 1 May 2021.