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Monoclonal Antibodies

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

Phase 3

Recruiting

Research Sponsored by Swedish Orphan Biovitrum

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of SLE as per SLICC'12 criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at any time after cr, up to 1 year

Awards & highlights

EMERALD Trial Summary

This trial is testing a new drug to see if it's safe and effective for treating macrophage activation syndrome (sHLH/MAS) in people with Still's disease or systemic lupus erythematosus.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects of Emapalumab may include allergic reactions due to hypersensitivity, increased risk of infections due to immune system suppression, and possibly other unknown risks that are common when testing new medications.

EMERALD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with lupus according to the SLICC'12 criteria.

EMERALD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at any time after cr, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at any time after cr, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at any time after cr, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects with complete response (CR) at Week 8 after first administration of emapalumab

Secondary outcome measures

GCs tapering to a dose below 50% of prednisolone (PDN) equivalent at the time of emapalumab start or to the same (or lower) dose being administered before the occurrence of MAS whichever occurs first

Gas Chromatography

MAS recurrence at anytime after achievement of CR

+6 more

Other outcome measures

Adverse Events (AEs) (serious and non-serious).

Immunogenicity endpoints

Laboratory parameters

+13 more

Side effects data

From 2021 Phase 2 & 3 trial • 58 Patients • NCT02069899

29%

Viral upper respiratory tract infection

14%

Dental caries

14%

Cholelithiasis

14%

Headache

14%

Still's disease

Epstein-Barr virus infection

Arthritis

Nausea

Rhinovirus infection

Adverse event following immunisation

Osteonecrosis

Rash erythematous

Viral infection

Condition aggravated

Enterovirus infection

Dysphonia

Oedema peripheral

Pyrexia

Arthralgia

Oropharyngeal pain

Urticaria

Lymphopenia

Skin laceration

Rash papular

Rectal prolapse

Cestode infection

Blood alkaline phosphatase increased

100%

80%

60%

40%

20%

Study treatment Arm

Enrolled-06 Cohort

Enrolled-CU Cohort

Enrolled-04 Cohort

EMERALD Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emapalumab

2014

Completed Phase 3

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Swedish Orphan BiovitrumLead Sponsor

92 Previous Clinical Trials

12,473 Total Patients Enrolled

Veronica Asnaghi, MDStudy ChairSwedish Orphan Biovitrum

Brian Jamieson, MDStudy DirectorSwedish Orphan Biovitrum

Media Library

Emapalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05001737 — Phase 3

Lupus Research Study Groups: Cohort 1 (sJIA and AOSD) and Cohort 2 (SLE)

Lupus Clinical Trial 2023: Emapalumab Highlights & Side Effects. Trial Name: NCT05001737 — Phase 3

Emapalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05001737 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the first time researchers have looked into Emapalumab?

"Emapalumab was first researched at Osaka Medical and Pharmaceutical University Hospital in the year 2021. Since then, there have been 5 completed studies with 1 ongoing clinical trial. The majority of the research being conducted surrounding emapalumab is happening in Montréal, Florida."

Answered by AI

Is this study innovative in any way?

"Emapalumab, which is being trialed by 9 cities across 11 countries, is currently in its first year of testing. The first study occurred in 2021 and was sponsored by Swedish Orphan Biovitrum. 41 patients completed Phase 3 of the trial and it is now awaiting drug approval. 5 trials have been conducted in total since 2021."

Answered by AI

Are doctors and clinics still enrolling patients in this trial?

"That is correct, according to the latest information on clinicaltrials.gov, this trial is still looking for patients. The listing was put up on December 15th, 2021 and was updated most recently on October 31st, 2022. In total, the study needs 41 people at 14 different sites."

Answered by AI

Has Emapalumab been cleared by the FDA?

"Emapalumab's safety is well-documented, as it has reached Phase 3 in clinical trials."

Answered by AI

Does this medical research allow for adults under the age of 35?

"The required age range for participation in this trial is between 6 months and 80 years old."

Answered by AI

What type of patient is eligible for this research project?

"The current study is investigating a potential treatment for macrophage activation syndrome. In order to qualify, patients must be between 6 months and 80 years old. Up to 41 people will be accepted into the trial."

Answered by AI

Is this trial widely available in urban areas?

"Presently, there are 14 sites enrolling patients for this research. If you reside near Montréal, Gainesville, or Philadelphia, you may have the opportunity to participate in this study without having to travel far. However, if you do not live near these cities, there are still 11 other potential locations for you to consider."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE

2021. "Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05001737.

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