Emapalumab for MAS in Still's Disease or Lupus
(EMERALD Trial)

Recruiting in Palo Alto (17 mi)

+46 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Swedish Orphan Biovitrum

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing emapalumab, a medication that helps control an overactive immune system, in children and adults with certain immune conditions who haven't responded to high-dose steroids. The goal is to see if it is safe and effective in reducing excessive inflammation. Emapalumab is a monoclonal antibody that targets interferon-γ and was first approved for treating primary hemophagocytic lymphohistiocytosis (HLH) in patients with refractory, recurrent, or progressive disease.

Research Team

Brian Jamieson, MD

Principal Investigator

Swedish Orphan Biovitrum

Eligibility Criteria

This trial is for children and adults aged 6 months to 80 years with macrophage activation syndrome (MAS) in Still's disease or systemic lupus erythematosus (SLE), who haven't responded well to high-dose steroids. Participants must meet specific criteria including fever, low platelets, high liver enzymes, and others. Pregnant women, those with certain infections or allergies to the study drug, or recent recipients of live vaccines cannot join.

Inclusion Criteria

Confirmed diagnosis of AOSD as per Yamaguchi criteria.

I am willing to use effective birth control from the start of the study until 6 months after the last dose.

Cohort 1:

See 11 more

Exclusion Criteria

My cancer diagnosis has been confirmed.

I am not taking canakinumab, JAK inhibitors, TNF inhibitors, or tocilizumab when starting emapalumab.

Pregnancy or lactating female subjects.

See 9 more

Treatment Details

Interventions

Emapalumab (Monoclonal Antibodies)

Trial OverviewThe trial tests Emapalumab's safety and effectiveness in treating MAS associated with Still's disease or SLE when standard steroid treatments fail. It involves patients receiving Emapalumab under controlled conditions to see if it improves their symptoms compared to previous treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Cohort 1 (sJIA and AOSD) and Cohort 2 (SLE)Experimental Treatment1 Intervention

MAS in the context of systemic juvenile idiopathic arthritis and adult onset Still's disease (sJIA and AOSD) or SLE

Emapalumab is already approved in United States for the following indications:

🇺🇸 Approved in United States as Gamifant for: