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Monoclonal Antibodies
Emapalumab for Primary Hemophagocytic Lymphohistiocytosis
Phase 3
Waitlist Available
Research Sponsored by Swedish Orphan Biovitrum
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary HLH patients with active disease.
Treatment naïve patients or patients having already received HLH conventional therapy, but having failed or unable to tolerate current standard of care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post hsct
Awards & highlights
Study Summary
This trial is designed to expand the knowledge on the efficacy and safety of emapalumab as a treatment for primary haemophagocytic lymphohistiocytosis (HLH) patients, with special focus on long-term outcome and quality of life assessments.
Eligible Conditions
- Primary Hemophagocytic Lymphohistiocytosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post hsct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post hsct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response at Week 8 or End of Treatment (if Earlier)
Secondary outcome measures
Duration of Response
Event-free Survival
Evolution of Laboratory Parameters Change From Baseline to EOT/Week 8
+11 moreOther outcome measures
Change in Pharmacodynamic Parameters
Number of Patients Who Demonstrated a Presence of Circulating Antibodies Against Emapalumab to Determine Immunogenicity
Serum Concentrations of Emapalumab
Side effects data
From 2021 Phase 2 & 3 trial • 58 Patients • NCT0206989929%
Viral upper respiratory tract infection
14%
Dental caries
14%
Cholelithiasis
14%
Headache
14%
Still's disease
7%
Enterovirus infection
7%
Adverse event following immunisation
7%
Rash erythematous
7%
Nausea
7%
Viral infection
7%
Osteonecrosis
7%
Dysphonia
7%
Arthritis
7%
Oedema peripheral
7%
Pyrexia
7%
Arthralgia
7%
Oropharyngeal pain
7%
Urticaria
7%
Lymphopenia
7%
Skin laceration
7%
Condition aggravated
7%
Epstein-Barr virus infection
7%
Rhinovirus infection
7%
Rash papular
7%
Rectal prolapse
7%
Cestode infection
7%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enrolled-06 Cohort
Enrolled-CU Cohort
Enrolled-04 Cohort
Trial Design
1Treatment groups
Experimental Treatment
Group I: EmapalumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emapalumab
2014
Completed Phase 3
~110
Find a Location
Who is running the clinical trial?
Swedish Orphan BiovitrumLead Sponsor
91 Previous Clinical Trials
12,179 Total Patients Enrolled
2 Trials studying Primary Hemophagocytic Lymphohistiocytosis
58 Patients Enrolled for Primary Hemophagocytic Lymphohistiocytosis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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