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

Primary Purpose

Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Emapalumab
Sponsored by
Swedish Orphan Biovitrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macrophage Activation Syndrome

Eligibility Criteria

6 Months - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Run-in phase in all cohorts

  1. Informed consent provided by the subject or by the subject s' legally authorized representative(s) with the assent of subjects who are legally capable of providing it, as required by local law.
  2. Male and female subjects aged between 6 months and 80 years of age at the time of diagnosis of MAS.
  3. MAS defined as per the criteria defined below for each cohort and requiring treatment with GCs.

Interventional phase in all cohorts

  1. Informed consent provided by the subject or by the subject's legally authorized representative(s) with the assent of subjects who are legally capable of providing it, as as required by local law.
  2. Male and female subjects aged between 6 months and 80 years of age at the time of diagnosis of active MAS.
  3. Subjects who have shown an inadequate response to high dose intravenous (i.v.) GCs administered for at least 3 days according to local standard clinical practice, including but not limited to pulses of 30 mg/kg PDN on 3 consecutive days. High i.v. GCs dose is recommended not to be lower than 2 mg/kg/ day PDN equivalent (or at least 60 mg/day in pediatric subjects of 30 kg or more, and at least 1g/day in adult MAS subjects). In case of rapid worsening of the subject's condition and/or laboratory parameters, as per Investigator judgment, inclusion may occur within less than 3 days from starting high dose GCs.
  4. Diagnosis of active MAS confirmed by the treating rheumatologist, having ascertained the followings:

    a. Febrile subjects presenting with ferritin > 684 ng/mL. b. and any 2 of: i. Platelet count ≤ 181 x109/L ii. AST-level > 48 U/L iii. Triglycerides > 156 mg/dL iv. Fibrinogen level ≤ 360 mg/dL

  5. Female subjects of child-bearing potential willing to use highly effective methods of contraception from study drug initiation to 6 months after the last dose of study drug.

    Specific inclusion criteria to Cohort 1 and Cohort 2

  6. Cohort 1:

    1. Confirmed sJIA diagnosis. For subjects presenting with MAS in the context of the onset of sJIA, high presumption of sJIA will suffice for eligibility.
    2. Confirmed diagnosis of AOSD as per Yamaguchi criteria.
  7. Cohort 2:

    1. Confirmed diagnosis of SLE as per SLICC'12 criteria.

Exclusion criteria

  1. Primary HLH documented by either the presence of a known causative genetic mutation or abnormal perforin expression and CD107a degranulation assay as described with primary hemophagocytic lymphohistiocytosis or by the presence of family history.
  2. Confirmed malignancy. Note: subjects with a suspected malignancy should have mononuclear cells typed by flow cytometry and/or tissue biopsy, as applicable, to rule out malignancy.
  3. Treatment with canakinumab, JAK inhibitors, TNF inhibitors and tocilizumab at the time of emapalumab initiation.
  4. Ongoing treatment with anakinra at a dose above 4 mg/kg at time of emapalumab initiation.
  5. Subjects treated with etoposide for MAS in the last 1 month.
  6. Clinically active mycobacteria (typical and atypical), Histoplasma Capsulatum, or Salmonella infections.
  7. Evidence of leishmania infections.
  8. Evidence of latent tuberculosis.
  9. History of hypersensitivity or allergy to any component of the study drug.
  10. Receipt of a Bacillus Calmette-Guerin (BCG) vaccine within 12 weeks prior to screening.
  11. Receipt of a live or attenuated live (other than BCG) vaccine within 4 weeks prior to screening.
  12. Pregnancy or lactating female subjects.

Sites / Locations

  • UAB HospitalRecruiting
  • University of FloridaRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Boston Children's HospitalRecruiting
  • University of Minnesota Masonic Children's HospitalRecruiting
  • Akron Children's HospitalRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Nationwide Children's Hospital, Abigail Wexner Research InstituteRecruiting
  • UPMC Children's Hospital of PittsburghRecruiting
  • Primary Children's HospitalRecruiting
  • Rheumatology Clinic at University of Washington Medical Center - RooseveltRecruiting
  • Universitair Ziekenhuis LeuvenRecruiting
  • Alberta Children's HospitalRecruiting
  • University of CalgaryRecruiting
  • Centre Hospitalier de l'Université de MontréalRecruiting
  • Centre Hospitalier Universitaire Sainte-JustineRecruiting
  • Hospital for sick childrenRecruiting
  • Beijing Children's HospitalRecruiting
  • Beijing Friendship HospitalRecruiting
  • Children's Hospital of Fudan UniversityRecruiting
  • Fakultní nemocnice OlomoucRecruiting
  • Vseobecna Fakultni Nemocnice v PrazeRecruiting
  • Hôpital Claude HuriezRecruiting
  • Hôpital De La ConceptionRecruiting
  • Hôpital Necker-Enfants MaladesRecruiting
  • Hôpital Universitaire Pitié SalpêtrièreRecruiting
  • Charité UniversitätsmedizinRecruiting
  • Universitätsklinikum HeidelbergRecruiting
  • IRCCS G. GasliniRecruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
  • Ospedale Pediatrico Bambino GesùRecruiting
  • IRCCS - Materno-Infantile Burlo GarofoloRecruiting
  • St. Marianna University School of Medicine HospitalRecruiting
  • Osaka Medical and Pharmaceutical University HospitalRecruiting
  • Tokyo Medical and Dental University HospitalRecruiting
  • Yokohama City University HospitalRecruiting
  • UMC UtrechtRecruiting
  • Szpital Specjalistyczny im. J. Dietla w KrakowieRecruiting
  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w KrakowieRecruiting
  • Ortopedyczno - Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w PoznaniuRecruiting
  • Hospital Sant Joan de DéuRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital UniversitarioRecruiting
  • Hospital Universitari i Politècnic La FeRecruiting
  • Karolinska Universitetssjukhuset Solna (Ped. Rheum.)Recruiting
  • Karolinska Universitetssjukhuset SolnaRecruiting
  • Great Ormond Street HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort 1 (sJIA and AOSD) and Cohort 2 (SLE)

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of subjects with complete response (CR) at Week 8 after first administration of emapalumab
Resolution of clinical signs and symptoms present at baseline: The MAS clinical activity will be measured on a visual analog scale (VAS) 10 cm. Resolution of clinical signs and symptoms present at baseline: The MAS clinical activity will be measured on a visual analog scale (VAS) 10 cm. Clinical signs will be considered as resolved if VAS is below or equal to 1/10. And Normalization of laboratory parameters relevant to MAS, as follows: WBC above LLN platelet count above LLN LDH below 1.5 ULN ALT below 1.5 ULN AST below 1.5 ULN fibrinogen higher than 100 mg/dL ferritin levels decreased by at least 80 % from values at screening or baseline (whichever is higher) or below 2000 ng/ml, whichever is low

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
GC tapering as per investigator discretion
GCs tapering to ≤1mg/kg/day of PDN equivalent at any time during the study.
GC tapering as per investigator discretion
Time to achieve GCs tapering as defined above.
GC tapering as per investigator discretion
Time to first Complete Remission
Time to CR
Proportion of subjects with overall response as defined by CR or PR
Resolution of clinical signs and symptoms present at baseline: The MAS clinical activity will be measured on a visual analog scale (VAS) 10 cm.
Time to first overall response as defined by CR or PR
CR defined as below: Resolution of clinical signs and symptoms present at baseline: The MAS clinical activity will be measured on a visual analog scale (VAS) 10 cm.
MAS recurrence at anytime after achievement of CR
Time to MAS recurrence after CR
Withdrawal from the study due to lack of response as per Investigator decision
Time to withdrawal
Survival time
Time to Survival

Full Information

First Posted
June 16, 2021
Last Updated
September 12, 2023
Sponsor
Swedish Orphan Biovitrum
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1. Study Identification

Unique Protocol Identification Number
NCT05001737
Brief Title
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
Acronym
EMERALD
Official Title
A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus Erythematous
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis and adult onset Still's disease) or with sHLH/MAS in systemic lupus erythematous, resenting an inadequate response to high dose glucocorticoid treatment.
Detailed Description
Study NI-0501-14 is a two-cohort trial that enrolls subjects who are diagnosed with sHLH/MAS (MAS being a form of secondary HLH) and who are presenting an inadequate response to high doses of GCs. These subjects will be enrolled in 2 cohorts as per their background disease. The cohorts are defined as follows: Cohort 1: MAS in the context of sJIA and AOSD. Cohort 2: MAS in the context of pediatric and adult SLE. The study has the objectives to investigate the efficacy, safety and tolerability, for 8 weeks, and PK and PD, QoL and immunogenicity in these 2 cohorts for up to 1 year after last dose of of emapalumab. Macrophage Activation Syndrome (MAS) Secondary Hemophagocytic Lymphohistiocytosis (sHLH) systemic Juvenile Idiopathic Arthritis (sJIA) Adult-onset Still's Disease (AOSD) Systemic Lupus Erythematosus (SLE)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus, SJIA, AOSD, MAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
2 cohorts
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 (sJIA and AOSD) and Cohort 2 (SLE)
Arm Type
Experimental
Arm Description
MAS in the context of systemic juvenile idiopathic arthritis and adult onset Still's disease (sJIA and AOSD) or SLE
Intervention Type
Drug
Intervention Name(s)
Emapalumab
Other Intervention Name(s)
NI-0501, emapalumab-lzsg, ATC code: L04AA39 (WHO)
Intervention Description
Emapalumab iv infusion
Primary Outcome Measure Information:
Title
Proportion of subjects with complete response (CR) at Week 8 after first administration of emapalumab
Description
Resolution of clinical signs and symptoms present at baseline: The MAS clinical activity will be measured on a visual analog scale (VAS) 10 cm. Resolution of clinical signs and symptoms present at baseline: The MAS clinical activity will be measured on a visual analog scale (VAS) 10 cm. Clinical signs will be considered as resolved if VAS is below or equal to 1/10. And Normalization of laboratory parameters relevant to MAS, as follows: WBC above LLN platelet count above LLN LDH below 1.5 ULN ALT below 1.5 ULN AST below 1.5 ULN fibrinogen higher than 100 mg/dL ferritin levels decreased by at least 80 % from values at screening or baseline (whichever is higher) or below 2000 ng/ml, whichever is low
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
Description
GC tapering as per investigator discretion
Time Frame
At any time in the study, up to 1 year
Title
GCs tapering to ≤1mg/kg/day of PDN equivalent at any time during the study.
Description
GC tapering as per investigator discretion
Time Frame
At any time in the study, up to 1 year
Title
Time to achieve GCs tapering as defined above.
Description
GC tapering as per investigator discretion
Time Frame
At any time in the study, up to 1 year
Title
Time to first Complete Remission
Description
Time to CR
Time Frame
At any time in the study, up to 1 year
Title
Proportion of subjects with overall response as defined by CR or PR
Description
Resolution of clinical signs and symptoms present at baseline: The MAS clinical activity will be measured on a visual analog scale (VAS) 10 cm.
Time Frame
At any time in the study, up to 1 year
Title
Time to first overall response as defined by CR or PR
Description
CR defined as below: Resolution of clinical signs and symptoms present at baseline: The MAS clinical activity will be measured on a visual analog scale (VAS) 10 cm.
Time Frame
At any time in the study, up to 1 year
Title
MAS recurrence at anytime after achievement of CR
Description
Time to MAS recurrence after CR
Time Frame
At any time after CR, up to 1 year
Title
Withdrawal from the study due to lack of response as per Investigator decision
Description
Time to withdrawal
Time Frame
At any time in the study, up to 1 year
Title
Survival time
Description
Time to Survival
Time Frame
At any time in the study, up to 1 year
Other Pre-specified Outcome Measures:
Title
Adverse Events (AEs) (serious and non-serious).
Description
Incidence, severity, causality and outcomes of AEs
Time Frame
At any time in the study, up to 1 year
Title
Study interruption due to safety reasons
Description
Number of subjects withdrawn due to safety reasons
Time Frame
At any time in the study, up to 1 year
Title
Laboratory parameters
Description
Changes from baseline
Time Frame
At any time in the study, up to 1 year
Title
Patient reported outcomes : PedsQL™;
Description
Pediatric Quality of Life Inventory (PedsQL™; Generic Core Scales and Infant Scales, Acute versions)
Time Frame
Screening, Week 8, month 6 and 1 year
Title
Patient reported outcomes: Patient/Parent Global Impression of Severity
Description
Health-related quality of life: Global Assessment: Patient/Parent Global Impression of Severity
Time Frame
Screening, Week 8, month 6 and 1 year
Title
Patient reported outcomes: Clinician Global Impression of Severity
Description
Health-related quality of life: Global Assessment: Clinician Global Impression of Severity
Time Frame
Screening, Week 8, month 6 and 1 year
Title
PK endpoints
Description
Serum concentrations of emapalumab vs. time
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
PK endpoints CEOI,
Description
PK parameters by non-compartmental analysis: CEOI,
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
PK endpoints: λz,
Description
PK parameters by non-compartmental analysis: λz,
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
PK endpoints: CL,
Description
PK parameters by non-compartmental analysis: CL,
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
PK endpoints: Vss,
Description
PK parameters by non-compartmental analysis: Vss,
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
PK endpoints: MRTlast and MRTinf
Description
PK parameters by non-compartmental analysis: MRTlast and MRTinf, as applicable
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
PD endpoints per cohort: free IFN-γ and total IFNγ
Description
• Levels of circulating free IFN-γ at pre-dose, and total IFNγ (free IFN-γ+bound to emapalumab) after initiation of the study drug.
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
PD endpoints per cohort: chemokines
Description
Levels of the main IFN-γ-induced chemokines (CXCL9, CXCL10).
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
PD endpoints per cohort: sCD25)
Description
Levels of MAS markers (sCD25).
Time Frame
Every treatment visit until week 8, Day 60, Day 100, 6 months, 1 year
Title
Immunogenicity endpoints
Description
Occurrence of ADAs, Nab to emapalumab
Time Frame
Treatment visit 1, week 8, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Run-in phase in all cohorts Informed consent provided by the subject or by the subject s' legally authorized representative(s) with the assent of subjects who are legally capable of providing it, as required by local law. Male and female subjects aged between 6 months and 80 years of age at the time of diagnosis of MAS. MAS defined as per the criteria defined below for each cohort and requiring treatment with GCs. Interventional phase in all cohorts Informed consent provided by the subject or by the subject's legally authorized representative(s) with the assent of subjects who are legally capable of providing it, as as required by local law. Male and female subjects aged between 6 months and 80 years of age at the time of diagnosis of active MAS. Subjects who have shown an inadequate response to high dose intravenous (i.v.) GCs administered for at least 3 days according to local standard clinical practice, including but not limited to pulses of 30 mg/kg PDN on 3 consecutive days. High i.v. GCs dose is recommended not to be lower than 2 mg/kg/ day PDN equivalent (or at least 60 mg/day in pediatric subjects of 30 kg or more, and at least 1g/day in adult MAS subjects). In case of rapid worsening of the subject's condition and/or laboratory parameters, as per Investigator judgment, inclusion may occur within less than 3 days from starting high dose GCs. Diagnosis of active MAS confirmed by the treating rheumatologist, having ascertained the followings: a. Febrile subjects presenting with ferritin > 684 ng/mL. b. and any 2 of: i. Platelet count ≤ 181 x109/L ii. AST-level > 48 U/L iii. Triglycerides > 156 mg/dL iv. Fibrinogen level ≤ 360 mg/dL Female subjects of child-bearing potential willing to use highly effective methods of contraception from study drug initiation to 6 months after the last dose of study drug. Specific inclusion criteria to Cohort 1 and Cohort 2 Cohort 1: Confirmed sJIA diagnosis. For subjects presenting with MAS in the context of the onset of sJIA, high presumption of sJIA will suffice for eligibility. Confirmed diagnosis of AOSD as per Yamaguchi criteria. Cohort 2: Confirmed diagnosis of SLE as per SLICC'12 criteria. Exclusion criteria Primary HLH documented by either the presence of a known causative genetic mutation or abnormal perforin expression and CD107a degranulation assay as described with primary hemophagocytic lymphohistiocytosis or by the presence of family history. Confirmed malignancy. Note: subjects with a suspected malignancy should have mononuclear cells typed by flow cytometry and/or tissue biopsy, as applicable, to rule out malignancy. Treatment with canakinumab, JAK inhibitors, TNF inhibitors and tocilizumab at the time of emapalumab initiation. Ongoing treatment with anakinra at a dose above 4 mg/kg at time of emapalumab initiation. Subjects treated with etoposide for MAS in the last 1 month. Clinically active mycobacteria (typical and atypical), Histoplasma Capsulatum, or Salmonella infections. Evidence of leishmania infections. Evidence of latent tuberculosis. History of hypersensitivity or allergy to any component of the study drug. Receipt of a Bacillus Calmette-Guerin (BCG) vaccine within 12 weeks prior to screening. Receipt of a live or attenuated live (other than BCG) vaccine within 4 weeks prior to screening. Pregnancy or lactating female subjects.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adnan Mahmood, MD
Phone
+46(0)8 697 20 00
Email
Adnan.Mahmood@sobi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Westerdahl
Email
Anna.Westerdahl@sobi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radmila Kanceva, MD
Organizational Affiliation
Swedish Orphan Biovitrum
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Rubio, MD
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Elder, MD
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Chandrakasan, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Henderson, MD
Facility Name
University of Minnesota Masonic Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Binstadt, MD
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Cook, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Grom, MD
Facility Name
Nationwide Children's Hospital, Abigail Wexner Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Akoghlanian, MD
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Rosenkranz, MD
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Hersh, MD
Facility Name
Rheumatology Clinic at University of Washington Medical Center - Roosevelt
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Singh, MD
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. De Somer, MD
Facility Name
Alberta Children's Hospital
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Benseler, MD
Facility Name
University of Calgary
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. MacMullan, MD
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Chapdelaine, MD
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Decaluwe, MD
Facility Name
Hospital for sick children
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Levy, MD
Facility Name
Beijing Children's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Li, MD
Facility Name
Beijing Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Wang, MD
Facility Name
Children's Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Sun, MD
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Bouchalova, MD
Facility Name
Vseobecna Fakultni Nemocnice v Praze
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Dolezalova, MD
Facility Name
Hôpital Claude Huriez
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Hachulla, MD
First Name & Middle Initial & Last Name & Degree
Dr. Terriou, MD
Facility Name
Hôpital De La Conception
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Kaplanski, MD
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Quartier, MD
Facility Name
Hôpital Universitaire Pitié Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Fautrel, MD
Facility Name
Charité Universitätsmedizin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Biesen, MD
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Blank, MD
Facility Name
IRCCS G. Gaslini
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Gattorno, MD
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Filocamo, MD
Facility Name
Ospedale Pediatrico Bambino Gesù
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. De Benedetti, MD
Facility Name
IRCCS - Materno-Infantile Burlo Garofolo
City
Trieste
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Tommasini, MD
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Mori, MD
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ozeki, MD
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Shimizu, MD
Facility Name
Yokohama City University Hospital
City
Yokohama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ito, MD
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Vastert, MD
Facility Name
Szpital Specjalistyczny im. J. Dietla w Krakowie
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr. Dr. Batko, MD
Facility Name
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Zuber, MD
Facility Name
Ortopedyczno - Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Samborski, MD
Facility Name
Hospital Sant Joan de Déu
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Antón López, MD
Facility Name
Hospital Universitario La Paz
City
La Paz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Remesal, MD
Facility Name
Hospital Universitario
City
La Paz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Robles-Marhuenda, MD
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Calvo Penade, MD
Facility Name
Karolinska Universitetssjukhuset Solna (Ped. Rheum.)
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Horne, MD
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Faustini, MD
Facility Name
Great Ormond Street Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Brogan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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