Clinical trial • Phase III • Haematology|Rare Disease

ANSELAMIMAB for Amyloid light-chain (AL) amyloidosis | Cardiac amyloidosis (Mayo stage IIIa)

Phase III trial of ANSELAMIMAB for Amyloid light-chain (AL) amyloidosis | Cardiac amyloidosis (Mayo stage IIIa).

Overview

Trial Therapeutic Area
Haematology|Rare Disease
Trial Disease
Amyloid light-chain (AL) amyloidosis | Cardiac amyloidosis (Mayo stage IIIa)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Other
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
30-04-2024
First CTIS Authorization Date
13-06-2024

Trial design

Randomised, placebo: sodium chloride intravenous infusion (0.9% nacl) plus plasma cell dyscrasia treatment (cybord-based soc). active arm: cael-101 (anselamimab) intravenous infusion plus plasma cell dyscrasia treatment (cybord-based soc). dose and schedule not specified in provided documents.-controlled Phase III trial in Poland, Italy, Greece and others.

Randomised
Yes
Comparator
Placebo: SODIUM CHLORIDE intravenous infusion (0.9% NaCl) plus plasma cell dyscrasia treatment (CyBorD-based SoC). Active arm: CAEL-101 (anselamimab) intravenous infusion plus plasma cell dyscrasia treatment (CyBorD-based SoC). Dose and schedule not specified in provided documents.
Target Sample Size
198
Trial Duration For Participant
350

Eligibility

Recruits 198 The trial has vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Informed consent is required: "Each patient will be assigned a unique identifier after signing the Informed Consent Form (ICF). Patient numbers will not be reassigned. Any patient records or datasets transferred to the Sponsor must contain only the unique identifier and must not include patient names or any information which would make the patient identifiable. Patients will be informed that their personal study-related data will be used by the Sponsor in accordance with local data protection laws and that their medical records may be examined by representatives of the Sponsor, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) members and by inspectors from regulatory authorities. Study monitors will inspect all documents and records that are required to be maintained by the Investigator for this study.' Consent is provided by adult patients via the ICF; multiple language ICFs are provided (see consent languages). No separate assent procedure for minors is described in the available documents..

Pregnancy Exclusion
Women of childbearing potential must have a negative pregnancy test during Screening and must agree to use highly effective contraception from Screening to at least 5 months following the last study drug administration or 12 months following the last dose of her PCD therapy, whichever is longer
Vulnerable Population
The trial has vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Informed consent is required: "Each patient will be assigned a unique identifier after signing the Informed Consent Form (ICF). Patient numbers will not be reassigned. Any patient records or datasets transferred to the Sponsor must contain only the unique identifier and must not include patient names or any information which would make the patient identifiable. Patients will be informed that their personal study-related data will be used by the Sponsor in accordance with local data protection laws and that their medical records may be examined by representatives of the Sponsor, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) members and by inspectors from regulatory authorities. Study monitors will inspect all documents and records that are required to be maintained by the Investigator for this study.' Consent is provided by adult patients via the ICF; multiple language ICFs are provided (see consent languages). No separate assent procedure for minors is described in the available documents.

Inclusion criteria

  • {"criterion_text":"- AL amyloidosis stage IIIa based on the European Modification of the 2004 Standard Mayo Clinic Staging who also have NT-proBNP ≥ 650 ng/L at the time of Screening\n- Measurable hematologic disease at Screening as defined by at least one of the following: a. Involved/uninvolved free light chain difference (dFLC) > 4 mg/dL OR b. Involved free light chain (iFLC) > 4 mg/dL with abnormal Kappa/Lambda ratio OR c. Serum protein electrophoresis (SPEP) m-spike > 0.5 g/dL\n- Histopathological diagnosis of amyloidosis based on polarizing light microscopy of green bi-refringent material in Congo red stained tissue specimens AND confirmation of AL derived amyloid deposits by at least one of the following: a. Immunohistochemistry/Immunofluorescence OR b. Mass spectrometry OR c. Characteristic electron microscopy appearance/Immunoelectron microscopy\n- Cardiac involvement as defined by: a. Documented clinical signs and symptoms supportive of a diagnosis of heart failure in the setting of a confirmed diagnosis of AL amyloidosis in the absence of an alternative explanation for heart failure AND b. At least one of the following: I. Endomyocardial biopsy demonstrating AL cardiac amyloidosis OR ii. Echocardiogram demonstrating a mean left ventricular wall thickness (calculated as [IVSd+LPWd]/2) of > 12 mm at diastole in the absence of other causes (e.g., severe hypertension, aortic stenosis), which would adequately explain the degree of wall thickening OR iii. Cardiac magnetic resonance imaging (MRI) with gadolinium contrast agent diagnostic of cardiac amyloidosis\n- Planned first-line treatment for plasma cell dyscrasia is cyclophosphamide-bortezomib-dexamethasone (CyBorD)-based regimen administered as SoC.\n- Women of childbearing potential must have a negative pregnancy test during Screening and must agree to use highly effective contraception from Screening to at least 5 months following the last study drug administration or 12 months following the last dose of her PCD therapy, whichever is longer\n- Men must be surgically sterile or must agree to use highly effective contraception and refrain from donating sperm from Screening to at least 5 months following the last study drug administration or 12 months following the last dose of their PCD therapy, whichever is longer"}

Exclusion criteria

  • {"criterion_text":"- Have any other form of amyloidosis other than AL amyloidosis\n- Received prior therapy for AL amyloidosis or multiple myeloma. A maximum exposure of 2 weeks of a CyBorD-based PCD treatment after Screening laboratory samples are obtained and prior to randomization is allowed.\n- Has POEMS syndrome OR multiple myeloma defined as clonal bone marrow plasma cells > 10% from a bone marrow biopsy (performed ≤ 3 months prior to signing the ICF or during Screening) OR biopsy-proven (performed ≤ 3 months prior to signing the ICF or during Screening) bony or extramedullary plasmacytoma AND any one or more of the following CRAB features: a. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, (eg, multiple myeloma and POEMS syndrome), specifically: i. Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the ULN or > 2.75 mmol/L (> 11 mg/dL) OR ii. Renal insufficiency: creatinine clearance < 40 mL per minute or serum creatinine > 177 μmol/L (> 2 mg/dL) OR iii. Anemia: hemoglobin value of > 20 g/L below the lowest limit of normal, or a hemoglobin value < 100 g/L OR iv. Bone lesions: one or more osteolytic lesion on imaging tests (performed ≤ 3 months prior to signing the ICF or during Screening): skeletal radiography, CT, or PET/CT, or MRI. If bone marrow has < 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement OR b. Any one of the following biomarkers of malignancy: i. 60% or greater clonal plasma cells on bone marrow examination OR ii. More than one focal lesion on MRI that is at least 5mm or greater in size\n- Have supine systolic blood pressure < 90 mmHg or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of > 30 mmHg despite medical management (e.g., midodrine, fludrocortisones) in the absence of volume depletion"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- A hierarchical combination of time to all-cause Mortality (ACM) and the frequency of cardiovascular hospitalizations (CVH). Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). Changes from baseline in vital signs, weight, clinical laboratory tests, and 12lead electrocardiograms (ECGs).","definition_or_measurement_approach":"Hierarchical combination: time-to-event assessment for all-cause mortality (ACM) and count/frequency assessment of cardiovascular hospitalizations (CVH). Safety assessed by incidence of TEAEs and SAEs. Additional measures: changes from baseline in vital signs, weight, clinical laboratory tests, and 12-lead ECGs as recorded in clinic assessments."}

Secondary endpoints

  • {"endpoint_text":"- Time to ACM in Primary Evaluation Treatment Period (PETP)","definition_or_measurement_approach":"Time-to-event analysis for all-cause mortality during the Primary Evaluation Treatment Period (PETP)."}
  • {"endpoint_text":"- Frequency of CVH in PETP","definition_or_measurement_approach":"Frequency/count of cardiovascular-related hospitalizations during the PETP."}
  • {"endpoint_text":"- Changes from baseline to Week 50 in the KCCQ-OS.","definition_or_measurement_approach":"Change from baseline to Week 50 in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)."}
  • {"endpoint_text":"- Change from baseline to Week 50 in NTproBNP","definition_or_measurement_approach":"Change from baseline to Week 50 in NT-proBNP biomarker levels."}
  • {"endpoint_text":"- Changes from baseline to Week 50 in GLS%.","definition_or_measurement_approach":"Change from baseline to Week 50 in global longitudinal strain (GLS%)."}
  • {"endpoint_text":"- Changes from baseline to Week 50 in the 6MWT","definition_or_measurement_approach":"Change from baseline to Week 50 in distance walked in the six-minute walk test (6MWT)."}
  • {"endpoint_text":"- Change from baseline to Week 50 in the SF-36v2 PCS","definition_or_measurement_approach":"Change from baseline to Week 50 in the Short Form 36 Health Survey Physical Component Score (SF-36v2 PCS)."}

Recruitment

Planned Sample Size
198
Recruitment Window Months
77
Consent Approach
Informed consent is required and obtained via a signed Informed Consent Form (ICF). "Each patient will be assigned a unique identifier after signing the Informed Consent Form (ICF). Patient numbers will not be reassigned. Any patient records or datasets transferred to the Sponsor must contain only the unique identifier and must not include patient names or any information which would make the patient identifiable. Patients will be informed that their personal study-related data will be used by the Sponsor in accordance with local data protection laws and that their medical records may be examined by representatives of the Sponsor, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) members and by inspectors from regulatory authorities. Study monitors will inspect all documents and records that are required to be maintained by the Investigator for this study.' ICFs and patient information are provided in multiple languages (examples in the dossier: English, German, Greek, Polish, Spanish, French, Italian, Czech). No separate assent process for minors is described in the available documents.

Geography

Total Number Of Sites
37
Total Number Of Participants
83

Poland

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
130
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Monika Szarejko
Principal Investigator Email
monasza1@gumed.edu.pl
Contact Person Name
Monika Szarejko
Contact Person Email
monasza1@gumed.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
Principal Investigator Name
Krzysztof Jamroziak
Principal Investigator Email
k.m.jamroziak@gmail.com
Contact Person Name
Krzysztof Jamroziak
Contact Person Email
k.m.jamroziak@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
140
Number Of Sites
2
Number Of Participants
1

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UOS DH Ematologico
Principal Investigator Name
Alessandra Tucci
Principal Investigator Email
alessandra.tucci@asst-spedalicivili.it
Contact Person Name
Alessandra Tucci
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Medicina generale 2
Principal Investigator Name
Giovanni Palladini
Principal Investigator Email
giovanni.palladini@unipv.it
Contact Person Name
Giovanni Palladini
Contact Person Email
giovanni.palladini@unipv.it

Greece

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
04-07-2024
Processing Time Days
150
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
General University Hospital Of Patras
Department Name
Hematology Department of the Department of Internal Medicine of the General Hospital of Patras
Principal Investigator Name
Alexandros Spyridonidis
Principal Investigator Email
spyridonidis@upatras.gr
Contact Person Name
Alexandros Spyridonidis
Contact Person Email
spyridonidis@upatras.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
Hematology Department, First Department of Internal Medicine
Principal Investigator Name
Evdoxia Hatjiharissi
Principal Investigator Email
ehatjiharissi@gmail.com
Contact Person Name
Evdoxia Hatjiharissi
Contact Person Email
ehatjiharissi@gmail.com
Site Name
Alexandra Hospital
Department Name
Plasma Cell Dyscrasia Unit/ Therapeutic Clinic, Medical School
Principal Investigator Name
Efstathios Kastritis
Principal Investigator Email
ekastritis@med.uoa.gr
Contact Person Name
Efstathios Kastritis
Contact Person Email
ekastritis@med.uoa.gr

Czechia

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
133
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie FNO a LF OU
Principal Investigator Name
Roman Hájek
Principal Investigator Email
roman.hajek@fno.cz
Contact Person Name
Roman Hájek
Contact Person Email
roman.hajek@fno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Interní klinika - klinika hematologie 1.LF a VFN
Principal Investigator Name
František Sedlák
Principal Investigator Email
frantisek.sedlak@vfn.cz
Contact Person Name
František Sedlák
Contact Person Email
frantisek.sedlak@vfn.cz

Austria

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
18-06-2024
Processing Time Days
134
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Medicine I, Division of Hematology and Hemostaseology
Principal Investigator Name
Hermine Agis
Principal Investigator Email
hermine.agis@meduniwien.ac.at
Contact Person Name
Hermine Agis
Contact Person Email
hermine.agis@meduniwien.ac.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Internal 1 - Hematology with stem cell transplantation, hemostaseology and medical oncology
Principal Investigator Name
Irene Strassl
Principal Investigator Email
irene.strassl@ordensklinikum.at
Contact Person Name
Irene Strassl

Spain

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
13-06-2024
Processing Time Days
129
Number Of Sites
11
Number Of Participants
22

Sites

Site Name
Hospital Universitario De Cabuenes
Department Name
Hematology
Principal Investigator Name
Maria Esther Gonzalez García
Principal Investigator Email
gonzalezesther@uniovi.es
Contact Person Name
Maria Esther Gonzalez García
Contact Person Email
gonzalezesther@uniovi.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Eusebio Narciso Martín Chacón
Principal Investigator Email
eusebion.martin.sspa@juntadeandalucia.es
Contact Person Name
Eusebio Narciso Martín Chacón
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Principal Investigator Name
Elham Askari
Principal Investigator Email
EAskari@quironsalud.es
Contact Person Name
Elham Askari
Contact Person Email
EAskari@quironsalud.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Francisco Javier de la Rubia Comos
Principal Investigator Email
delarubia_jav@gva.es
Contact Person Name
Francisco Javier de la Rubia Comos
Contact Person Email
delarubia_jav@gva.es
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Principal Investigator Name
Maria Teresa Cibeira Lopez
Principal Investigator Email
mcibeira@clinic.cat
Contact Person Name
Maria Teresa Cibeira Lopez
Contact Person Email
mcibeira@clinic.cat
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Hematology
Principal Investigator Name
María Esther Clavero Sánchez
Principal Investigator Email
mariaeclavero@juntadeandalucia.es
Contact Person Name
María Esther Clavero Sánchez
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Verónica González de la Calle
Principal Investigator Email
vgcalle@saludcastillayleon.com
Contact Person Name
Verónica González de la Calle
Contact Person Email
vgcalle@saludcastillayleon.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Mercedes Gironella Mesa
Principal Investigator Email
mgironel@vhebron.net
Contact Person Name
Mercedes Gironella Mesa
Contact Person Email
mgironel@vhebron.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Hematology
Principal Investigator Name
Irene Romera Martinez
Principal Investigator Email
irene.romera@salud.madrid.org
Contact Person Name
Irene Romera Martinez
Contact Person Email
irene.romera@salud.madrid.org
Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Principal Investigator Name
Ramon Lecumberri Villamediana
Principal Investigator Email
rlecumber@unav.es
Contact Person Name
Ramon Lecumberri Villamediana
Contact Person Email
rlecumber@unav.es
Site Name
Hospital La Luz Grupo Quironsalud
Department Name
Cardiology
Principal Investigator Name
Roberto Martín Reyes
Principal Investigator Email
RmartinR@quironsalud.es
Contact Person Name
Roberto Martín Reyes
Contact Person Email
RmartinR@quironsalud.es

Germany

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
130
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Intern
Principal Investigator Name
Stefan Schönland
Principal Investigator Email
Stefan.Schoenland@med.uni-heidelberg.de
Contact Person Name
Stefan Schönland
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Oncology and clinical immunology
Principal Investigator Name
Roland Fenk
Principal Investigator Email
fenk@med.uni-duesseldorf.de
Contact Person Name
Roland Fenk
Contact Person Email
fenk@med.uni-duesseldorf.de
Site Name
HOPA MVZ GmbH
Department Name
Hematology and Oncology
Principal Investigator Name
Timo Hansen
Principal Investigator Email
timon.hansen@hopa.de
Contact Person Name
Timo Hansen
Contact Person Email
timon.hansen@hopa.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medical Clinic and Polyclinic II
Principal Investigator Name
Maximilian Johannes Steinhardt
Principal Investigator Email
steinhardt_M@ukw.de
Contact Person Name
Maximilian Johannes Steinhardt
Contact Person Email
steinhardt_M@ukw.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Hematology
Principal Investigator Name
Alexander Carpinteiro
Principal Investigator Email
alexander.carpinteiro@uk-essen.de
Contact Person Name
Alexander Carpinteiro
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Hematology, Oncology and Tumor Immunology (CBF)
Principal Investigator Name
Stephan Bohl
Principal Investigator Email
Stephan.Bohl@charite.de
Contact Person Name
Stephan Bohl
Contact Person Email
Stephan.Bohl@charite.de

France

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
18-06-2024
Processing Time Days
134
Number Of Sites
9
Number Of Participants
25

Sites

Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service d’Hématologie Clinique
Principal Investigator Name
Jean-Noël BASTIE
Principal Investigator Email
jean-noel.bastie@chu-dijon.fr
Contact Person Name
Jean-Noël BASTIE
Contact Person Email
jean-noel.bastie@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de médecine interne et maladies infectieuses
Principal Investigator Name
Jean-François VIALLARD
Principal Investigator Email
jean-fracois.viallard@chu-bordeaux.fr
Contact Person Name
Jean-François VIALLARD
Site Name
Institut Paoli Calmettes
Department Name
Département d'hématologie
Principal Investigator Name
Jean-Marc SCHIANO DE COLELLA
Principal Investigator Email
schianojm@ipc.unicancer.fr
Contact Person Name
Jean-Marc SCHIANO DE COLELLA
Contact Person Email
schianojm@ipc.unicancer.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service d’Hématologie Clinique et Thérapie Cellulaire
Principal Investigator Name
Arnaud JACCARD
Principal Investigator Email
arnaud.jaccard@chu-limoges.fr
Contact Person Name
Arnaud JACCARD
Contact Person Email
arnaud.jaccard@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Néphrologie-Transplantation
Principal Investigator Name
Antoine HUART
Principal Investigator Email
huart.a@chu-toulouse.fr
Contact Person Name
Antoine HUART
Contact Person Email
huart.a@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Unité Hémopathies Lymphoïdes
Principal Investigator Name
Karim BELHADJ
Principal Investigator Email
karim.belhadj@aphp.fr
Contact Person Name
Karim BELHADJ
Contact Person Email
karim.belhadj@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Service d'hematologie clinique
Principal Investigator Name
Lionel KARLIN
Principal Investigator Email
lionel.karlin@chu-lyon.fr
Contact Person Name
Lionel KARLIN
Contact Person Email
lionel.karlin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Hématologie Clinique
Principal Investigator Name
Caroline BAUGE
Principal Investigator Email
bauge-c@chu-caen.fr
Contact Person Name
Caroline BAUGE
Contact Person Email
bauge-c@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service de Néphrologie et transplantation rénale
Principal Investigator Name
Estelle DESPORT
Principal Investigator Email
estelle.desport@chu-poitiers.fr
Contact Person Name
Estelle DESPORT

Sponsor

Primary sponsor

Full Name
Alexion Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Responsibilities
Maintain eTMF, manage ePRO and Central Lab, periodic safety reporting responsibilities to Investigators in France; other operational/statistical responsibilities (multiple sponsorDuties entries).
Name
Almac Clinical Services LLC
Responsibilities
Duties code 14 (clinical supply/ logistics or similar as listed).
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Statistical programming, biostatistical support and lab services.
Name
Biotel Research LLC
Responsibilities
ECG analysis/review, medical image analysis/review.
Name
Signant Health LLC
Responsibilities
Electronic patient-reported outcome (ePRO) management.

Third parties

  • {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"ECG analysis/ review, Medical image analysis/ review (listed under sponsorDuties)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"Electronic patient-reported outcome (ePRO)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Multiple duties including e.g., maintain eTMF, manage ePRO and Central Lab, periodic safety reporting to Investigators in France, statistical and operational support (multiple sponsorDuties codes)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Duties code 14 (as listed in sponsorDuties)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"The Brigham And Women’s Hospital Inc.","duties_or_roles":"Echocardiogram (GLS%)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Statistical programming, biostatistical support; and code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Resolian Bioanalytics","duties_or_roles":"Duties code 4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Yourway Transport Inc.","duties_or_roles":"Management/Shipment of standard of care CyBorD for those sites that require it; duties codes 14 and 15","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Duties code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Duties code 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Duties including code 1, 12, 2 (local country responsibilities)","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
CAEL-101
Active Substance
ANSELAMIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Not authorised (investigational product)
Orphan Designation
Yes
Investigational Product Name
SODIUM CHLORIDE
Active Substance
potassium chloride ph. eur.; sodium hydrogen carbonate pheur; sodium chloride ph. eur.
Modality
Other
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (marketing authorised as an isotonic solution/placebo comparator)
Combination Treatment
Yes

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