Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
← catalyst calendarSponsored by Swedish Orphan Biovitrum (industry) · SOBI.ST — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
33actual
Sites
44
Countries
Belgium, Canada, China +10
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-26
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-12-15 | actual | When the study began enrolling |
| Primary completion | 2024-06-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-04 | actual | The whole study's end, after follow-up |
| First posted | 2021-08-12 | actual | When this record first appeared on the registry |
| Results posted | 2026-02-19 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Macrophage Activation Syndrome
- Secondary Hemophagocytic Lymphohistiocytosis
- Still Disease
- Systemic Lupus Erythematosus
- SJIA
- AOSD
- MAS
Intervention
- Drug: Emapalumab — also filed as NI-0501, emapalumab-lzsg, ATC code: L04AA39 (WHO)
Primary outcome
what the primary-completion date above is the date OFProportion of Subjects With Complete Response (CR) at Week 8 After First Administration of Emapalumab
measured 8 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-10-19 · 1.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-07-10 · 1.5 MB · SAP_001.pdf
Related
SOBI.ST · their whole pipeline · Systemic Lupus Erythematosus readouts
SOBI.ST's other studiesmost recently updated first
- A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients Phase 4 · Completed
- A Study of Avatrombopag in Adults With Aplastic Anemia Who Did Not Respond to, Cannot Receive, or Had Return of Disease After Standard Treatment Phase 2/3 · Not yet recruiting
- A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS) Phase 2 · Active, not recruiting
- Pacritinib Effectiveness in Real-world Settings — · Not yet recruiting
- Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study Phase 4 · Recruiting
Permalink · SOBI.ST's whole pipeline · Catalyst calendar · Every registered study · What changed