Clinical trial • Phase III • Haematology|Rare Disease

CONCIZUMAB for Haemophilia A|Haemophilia B

Phase III trial of CONCIZUMAB for Haemophilia A|Haemophilia B.

Overview

Trial Therapeutic Area: Haematology|Rare Disease
Trial Disease: Haemophilia A|Haemophilia B
Trial Stage: Phase III
Drug Modality: Monoclonal antibody
Paediatric Trial: Yes

Key dates

Initial CTIS Submission Date: 06-05-2024
First CTIS Authorization Date: 19-06-2024

Trial design

open-label, comparison is to each participant's previous on-demand treatment (historical within-subject comparator), not a concurrent randomized active comparator arm.-controlled Phase III trial in France, Romania, Norway and others.

Open Label: Yes
Comparator: Comparison is to each participant's previous on-demand treatment (historical within-subject comparator), not a concurrent randomized active comparator arm.
Real World Control: Yes
Target Sample Size: 105
Trial Duration For Participant: 1456

Eligibility

Recruits 105 paediatric patients.

Vulnerable Population: The trial includes vulnerable populations (children <12 years). "Informed consent/assent obtained before any study-related activities." Consent/assent procedures are used for minors; subject information and consent/assent materials for children, adolescents, parents/legal representatives (e.g. 'SI-IC Children', 'SI-IC Parents-LAR') and BYOD options are listed among the study documents. Multiple language versions of information/consent materials are provided (examples in the documentation: Italian, Greek, Spanish, Polish, French, English, Swedish, Bulgarian, Lithuanian, Romanian).

Inclusion criteria

{"criterion_text":"- Informed consent/assent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n- Diagnosis of congenital severe haemophilia A (FVIII <1%) or moderate/severe congenital haemophilia B (FIX ≤2%), or congenital haemophilia with inhibitors.\n- For arm 1 only: Male aged <12 years of age at the time of signing informed consent.\n- For arm 1 only: Patients with inhibitors (HAwI or HBwI): 1) Patients with HAwI with historical medical records of a total of at least 26 weeks of on-demand treatment(b) within the last 52 weeks prior to enrolment(a). 2) Patients with HBwI with historical medical records of a total of at least 26 weeks of on-demand treatment(b) within the last 52 weeks prior to enrolment(a). 3) Patients with HBwI regardless of the regimen and duration of previous haemophilia treatment(b). (a) For patients below 1 year of age that have been diagnosed with haemophilia <1 year prior to enrolment, historical medical records from time of diagnosis will suffice as long as medical records of a total of at least 26 weeks of relevant treatment is available. (b) On-demand or PPX treatment qualifying for this study is understood as patient-treatment solely for bleeds with intravenous coagulation factor-containing products.\n- For arm 1 only: Patients without inhibitors (HA or HB): 1) Patients with historical medical records of at least 52 weeks of on-demand treatment(b),(c) during the last year prior to enrolment and with at least 3 documented treated bleeds(d) during this period. 2) Patients with historical medical records of a total of at least 26 weeks of PPX treatment(b) within the last 52 weeks prior to enrolment(a). (a) For patients below 1 year of age that have been diagnosed with haemophilia <1 year prior to enrolment, historical medical records from time of diagnosis will suffice as long as medical records of a total of at least 26 weeks of relevant treatment is available. (b) On-demand or PPX treatment qualifying for this study is understood as patient-treatment solely for bleeds with intravenous coagulation factor-containing products. (c) Surgery related PPX or short-term PPX (e.g., in relation to a severe bleed) is not allowed. (d) For participants <2 years of age there is no limitation for number of documented treated bleeds in the medical history.\n- For arm 2 only: Male patients (regardless of age) previously treated with concizumab via compassionate use."}

Exclusion criteria

{"criterion_text":"- Known or suspected hypersensitivity to study intervention or related products.\n- Known inherited or acquired coagulation disorder other than congenital haemophilia.\n- Ongoing or planned Immune Tolerance Induction treatment.\n- History of thromboembolic disease(a). Current clinical signs of or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events(b). (a) Includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion. (b) Thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events."}

Endpoints

Primary endpoints

{"endpoint_text":"- For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s). Endpoint counts treated spontaneous and traumatic bleeding episodes in inhibitor patients with required prior on-demand treatment history."}
{"endpoint_text":"- For non-inhibitor patients treated on demand during at least the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s). Endpoint counts treated spontaneous and traumatic bleeding episodes in non-inhibitor patients with required prior on-demand history."}

Secondary endpoints

{"endpoint_text":"- Supportive secondary: For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic). Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of all bleeding episodes (spontaneous and traumatic) from week 0 to primary analysis cut-off; unit = count of episodes."}
{"endpoint_text":"- Supportive secondary: For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated spontaneous bleeding episodes from week 0 to primary analysis cut-off; unit = count of episodes."}
{"endpoint_text":"- Supportive secondary: For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated joint bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated joint bleeding episodes from week 0 to primary analysis cut-off; unit = count of episodes."}
{"endpoint_text":"- Supportive secondary: For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated bleeding episodes in baseline target joints from week 0 to primary analysis cut-off; unit = count of episodes."}
{"endpoint_text":"- Supportive secondary: For non-inhibitor patients treated on-demand during at least the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic). Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of all bleeding episodes (spontaneous and traumatic) from week 0 to primary analysis cut-off; unit = count of episodes."}
{"endpoint_text":"- Supportive secondary: For non-inhibitor patients treated on-demand during at least the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated spontaneous bleeding episodes from week 0 to primary analysis cut-off; unit = count of episodes."}
{"endpoint_text":"- Supportive secondary: For non-inhibitor patients treated on-demand at least the last 52 weeks prior enrolment: Number of treated joint bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated joint bleeding episodes from week 0 to primary analysis cut-off; unit = count of episodes."}
{"endpoint_text":"- Supportive secondary: For non-inhibitor patients treated on-demand at least the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated bleeding episodes in baseline target joints from week 0 to primary analysis cut-off; unit = count of episodes."}
{"endpoint_text":"- Secondary supportive: For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated spontaneous and traumatic bleeding episodes for non-inhibitor patients with ≥26 weeks PPX in prior 52 weeks; unit = count."}
{"endpoint_text":"- Secondary supportive: For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic). Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of all bleeding episodes for non-inhibitor patients with ≥26 weeks PPX in prior 52 weeks; unit = count."}
{"endpoint_text":"- Secondary supportive: For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated spontaneous bleeding episodes for non-inhibitor patients with ≥26 weeks PPX in prior 52 weeks; unit = count."}
{"endpoint_text":"- Secondary supportive: For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated joint bleeding episodes. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated joint bleeding episodes for non-inhibitor patients with ≥26 weeks PPX; unit = count."}
{"endpoint_text":"- Secondary supportive: For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of episode(s).","definition_or_measurement_approach":"Counts of treated bleeding episodes in baseline target joints for non-inhibitor patients with ≥26 weeks PPX; unit = count."}
{"endpoint_text":"- Secondary supportive: Number of treatment emergent adverse events, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of event(s).","definition_or_measurement_approach":"Counts of treatment-emergent adverse events from week 0 to primary analysis cut-off; reported separately and combined; unit = count of events."}
{"endpoint_text":"- Secondary supportive: Number of thromboembolic events, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of event(s).","definition_or_measurement_approach":"Counts of thromboembolic events from week 0 to primary analysis cut-off; unit = count of events."}
{"endpoint_text":"- Secondary supportive: Number of hypersensitivity type reactions, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of reaction(s).","definition_or_measurement_approach":"Counts of hypersensitivity reactions from week 0 to primary analysis cut-off; unit = count of reactions."}
{"endpoint_text":"- Secondary supportive: Number of injection site reactions, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of reaction(s).","definition_or_measurement_approach":"Counts of injection site reactions from week 0 to primary analysis cut-off; unit = count of reactions."}
{"endpoint_text":"- Secondary supportive: Number of patients who develop antibodies to concizumab – yes/no, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of patient(s).","definition_or_measurement_approach":"Number of patients developing anti-concizumab antibodies (yes/no), reported separately and combined; unit = count of patients; timeframe up to primary analysis cut-off."}
{"endpoint_text":"- Secondary supportive: Number of treatment emergent adverse events, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: From start of treatment (week 0) up until the primary analysis cut-off. Unit: Count of event(s).","definition_or_measurement_approach":"Counts of treatment-emergent adverse events from week 0 to primary analysis cut-off; unit = count of events. (duplicate endpoint text present in source)"}
{"endpoint_text":"- Secondary supportive: Concizumab plasma concentrations prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: Week 32. Unit: ng/mL","definition_or_measurement_approach":"Pre-dose plasma concizumab concentrations at Week 32; unit = ng/mL."}
{"endpoint_text":"- Secondary supportive: Peak thrombin generation prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: Week 32. Unit: nM","definition_or_measurement_approach":"Peak thrombin generation measured prior to dosing at Week 32; unit = nM."}
{"endpoint_text":"- Secondary supportive: Free TFPI concentration prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: Week 32. Unit: ng/mL","definition_or_measurement_approach":"Free TFPI concentration measured prior to dosing at Week 32; unit = ng/mL."}
{"endpoint_text":"- Secondary supportive: Pre-dose (trough) concizumab plasma concentration (Ctrough), reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: Prior to the concizumab administration at week 20. Unit: ng/mL","definition_or_measurement_approach":"Trough concizumab plasma concentration prior to dosing at Week 20; unit = ng/mL."}
{"endpoint_text":"- Secondary supportive: Maximum concizumab plasma concentration (Cmax), reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: From 0 to 24 hours where 0 is the time of the concizumab dose at week 20. Unit: ng/mL","definition_or_measurement_approach":"Cmax measured from 0 to 24 hours post-dose at Week 20; unit = ng/mL."}
{"endpoint_text":"- Secondary supportive: Area under the concizumab plasma concentration-time curve (AUC), reported both separately for inhibitor and non-inhibitor patients and combined. Time frame: From 0 to 24 hours where 0 is the time of the concizumab dose at week 20. Unit: ng*hr/mL","definition_or_measurement_approach":"AUC (0-24h) for concizumab plasma concentration-time at Week 20; unit = ng*hr/mL."}

Recruitment

Planned Sample Size: 105
Recruitment Window Months: 86
Consent Approach: Informed consent/assent is required before any study-related activities. Materials and processes include age-appropriate subject information and consent/assent forms for children, adolescents, parents/legal representatives and BYOD options (documents listed: SI-IC Children, SI-IC Parents-LAR, SI-IC Adolescent, BYOD SI-IC). Consent materials are available in multiple language versions as provided in the study documents (examples: English, Italian, Greek, Spanish, Polish, French, Swedish, Bulgarian, Lithuanian, Romanian).

Geography

Total Number Of Sites: 23
Total Number Of Participants: 44

France

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 07-10-2025
Processing Time Days: 491
Number Of Sites: 2
Number Of Participants: 3

Sites

Site Name: Centre Hospitalier Metropole Savoie
Principal Investigator Name: Valérie Gay
Principal Investigator Email: Valerie.Gay@ch-metropole-savoie.fr
Contact Person Name: Valérie Gay
Contact Person Email: Valerie.Gay@ch-metropole-savoie.fr

Site Name: Assistance Publique Hopitaux De Paris
Principal Investigator Name: Annie Harroche
Principal Investigator Email: annie.harroche@aphp.fr
Contact Person Name: Annie Harroche
Contact Person Email: annie.harroche@aphp.fr

Romania

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 19-05-2025
Processing Time Days: 350
Number Of Sites: 3
Number Of Participants: 3

Sites

Site Name: Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca
Department Name: Pediatrie II
Principal Investigator Name: Cristina Blag
Principal Investigator Email: cristinablag@yahoo.com
Contact Person Name: Cristina Blag
Contact Person Email: cristinablag@yahoo.com

Site Name: Spitalul Clinic Judetean De Urgenta Bihor
Department Name: Pediatrie II
Principal Investigator Name: Cristian Sava
Principal Investigator Email: cristian.sava2004@gmail.com
Contact Person Name: Cristian Sava
Contact Person Email: cristian.sava2004@gmail.com

Site Name: Institutul Clinic Fundeni
Department Name: Pediatrie II
Principal Investigator Name: Anca Colita
Principal Investigator Email: ancacolita@yahoo.com
Contact Person Name: Anca Colita
Contact Person Email: ancacolita@yahoo.com

Norway

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 15-05-2025
Processing Time Days: 346
Number Of Sites: 1
Number Of Participants: 2

Sites

Site Name: Oslo University Hospital HF
Principal Investigator Name: Heidi Glosli
Principal Investigator Email: hglosli@ous-hf.no
Contact Person Name: Heidi Glosli
Contact Person Email: hglosli@ous-hf.no

Italy

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 03-10-2025
Processing Time Days: 487
Number Of Sites: 4
Number Of Participants: 9

Sites

Site Name: Careggi University Hospital
Principal Investigator Name: Silvia Linari
Principal Investigator Email: linaris@aou-careggi.toscana.it
Contact Person Name: Silvia Linari
Contact Person Email: linaris@aou-careggi.toscana.it

Site Name: Azienda Ospedale-Universita Padova
Principal Investigator Name: Ezio Zanon
Principal Investigator Email: ezio.zanon@unipd.it
Contact Person Name: Ezio Zanon
Contact Person Email: ezio.zanon@unipd.it

Site Name: Azienda Ospedaliero Universitaria Parma
Principal Investigator Name: Antonio Coppola
Principal Investigator Email: ancoppola@ao.pr.it
Contact Person Name: Antonio Coppola
Contact Person Email: ancoppola@ao.pr.it

Site Name: Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Principal Investigator Name: Gaetano Giuffrida
Principal Investigator Email: gaegiuffrida@gmail.com
Contact Person Name: Gaetano Giuffrida
Contact Person Email: gaegiuffrida@gmail.com

Sweden

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 03-10-2025
Processing Time Days: 487
Number Of Sites: 1
Number Of Participants: 2

Sites

Site Name: Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name: Koagulationscentrum
Principal Investigator Name: Fariba Baghaei
Principal Investigator Email: fariba.baghaei@vgregion.se
Contact Person Name: Fariba Baghaei
Contact Person Email: fariba.baghaei@vgregion.se

Greece

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 03-10-2025
Processing Time Days: 487
Number Of Sites: 2
Number Of Participants: 5

Sites

Site Name: Nosokomeio Paidon I Agia Sofia
Department Name: Haemophilia/Hemostasis Unit
Principal Investigator Name: Helen Pergantou
Principal Investigator Email: hpergantou@gmail.com
Contact Person Name: Helen Pergantou
Contact Person Email: hpergantou@gmail.com

Site Name: Ippokratio General Hospital Of Thessaloniki
Department Name: A pediatrics Clinic
Principal Investigator Name: Marina Economou
Principal Investigator Email: marina@med.auth.gr
Contact Person Name: Marina Economou
Contact Person Email: marina@med.auth.gr

Bulgaria

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 07-10-2025
Processing Time Days: 491
Number Of Sites: 1
Number Of Participants: 1

Sites

Site Name: University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name: Clinic of Pediatric
Principal Investigator Name: Mariya Spasova
Principal Investigator Email: merispa@mail.bg
Contact Person Name: Mariya Spasova
Contact Person Email: merispa@mail.bg

Poland

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 06-10-2025
Processing Time Days: 490
Number Of Sites: 4
Number Of Participants: 13

Sites

Site Name: Uniwersytecki Szpital Dzieciecy W Lublinie
Principal Investigator Name: Irena Woznica Karczmarz
Principal Investigator Email: irena.woznica-karczmarz@uszd.lublin.pl
Contact Person Name: Irena Woznica Karczmarz
Contact Person Email: irena.woznica-karczmarz@uszd.lublin.pl

Site Name: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Principal Investigator Name: Elzbieta Latos-Grazynska
Principal Investigator Email: egrazynska@yahoo.com
Contact Person Name: Elzbieta Latos-Grazynska
Contact Person Email: egrazynska@yahoo.com

Site Name: Uniwersyteckie Centrum Kliniczne
Principal Investigator Name: Julia Radon-Proskura
Principal Investigator Email: julia.radon-proskura@gumed.edu.pl
Contact Person Name: Julia Radon-Proskura
Contact Person Email: julia.radon-proskura@gumed.edu.pl

Site Name: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Principal Investigator Name: Pawel Laguna
Principal Investigator Email: pawelaguna@onet.eu
Contact Person Name: Pawel Laguna
Contact Person Email: pawelaguna@onet.eu

Lithuania

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 06-10-2025
Processing Time Days: 490
Number Of Sites: 1
Number Of Participants: 3

Sites

Site Name: Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Principal Investigator Name: Sonata Saulyte Trakymiene
Principal Investigator Email: sonata.saulytetrakymiene@santa.lt
Contact Person Name: Sonata Saulyte Trakymiene
Contact Person Email: sonata.saulytetrakymiene@santa.lt

Spain

Earliest CTIS Part Ii Submission Date: 03-06-2024
Latest Decision Or Authorization Date: 03-10-2025
Processing Time Days: 487
Number Of Sites: 4
Number Of Participants: 3

Sites

Site Name: Hospital Universitario Regional De Malaga
Principal Investigator Name: Francisco Lopez Jaime
Principal Investigator Email: franciscoj.lopez.jaime.sspa@juntadeandalucia.es
Contact Person Name: Francisco Lopez Jaime
Contact Person Email: franciscoj.lopez.jaime.sspa@juntadeandalucia.es

Site Name: Hospital Universitario La Paz
Principal Investigator Name: Víctor Jiménez Yuste
Principal Investigator Email: vjimenez.hulp@salud.madrid.org
Contact Person Name: Víctor Jiménez Yuste
Contact Person Email: vjimenez.hulp@salud.madrid.org

Site Name: University Clinical Hospital Virgen De La Arrixaca
Principal Investigator Name: Faustino García Candel
Principal Investigator Email: faustino.garcia2@carm.es
Contact Person Name: Faustino García Candel
Contact Person Email: faustino.garcia2@carm.es

Site Name: Vall D'hebron Institut De Recerca
Principal Investigator Name: Olga Benitez Hidalgo
Principal Investigator Email: olga.benitez@vallhebron.cat
Contact Person Name: Olga Benitez Hidalgo
Contact Person Email: olga.benitez@vallhebron.cat

Sponsor

Primary sponsor

Full Name: Novo Nordisk A/S
Organisation Type: Pharmaceutical company
Country Of Registered Address: Denmark

Contract research organisations

Name: Syneos Health Inc.
Responsibilities: Special Laboratory-Immunogenicity)

Name: Syneos Health Ba Limited
Responsibilities: Special Laboratory-Immunogenicity

Name: WCG Clinical Inc.
Responsibilities: Sponsor duty code 10 (statistical/other sponsor collaboration)

Name: 4G Clinical B.V.
Responsibilities: RTSM Supplier and RTSM helpdesk

Third parties

{"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eDairy supplier","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Special Laboratory-Immunogenicity)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"CRF supplier","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"Special Laboratory-Bioanalysis and IVD dose decision analysis","organisation_type":"Pharmaceutical company"}
{"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM Supplier and RTSM helpdesk","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central laboratory","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Syneos Health Ba Limited","duties_or_roles":"Special Laboratory-Immunogenicity","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Statistical collaboration / other sponsor duty (code 10)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: Concizumab C 100 mg/mL PDS290
Active Substance: CONCIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS
Route: SUBCUTANEOUS
Authorisation Status: Not authorised
Dose Levels: 10 mg/mL; 40 mg/mL; 100 mg/mL
Frequency: once-daily

Investigational Product Name: Concizumab C 40 mg/mL PDS290
Active Substance: CONCIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS
Route: SUBCUTANEOUS
Authorisation Status: Not authorised
Dose Levels: 10 mg/mL; 40 mg/mL; 100 mg/mL
Frequency: once-daily

Investigational Product Name: Concizumab C 10 mg/mL PDS290
Active Substance: CONCIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS
Route: SUBCUTANEOUS
Authorisation Status: Not authorised
Dose Levels: 10 mg/mL; 40 mg/mL; 100 mg/mL
Frequency: once-daily

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