Clinical trial • Phase III • Cardiology

ZILTIVEKIMAB for Heart failure with mildly reduced ejection fraction (HFmrEF) | Heart failure with preserved ejection fraction (HFpEF) | Systemic inflammation

Phase III trial of ZILTIVEKIMAB for Heart failure with mildly reduced ejection fraction (HFmrEF) | Heart failure with preserved ejection fraction (HFpEF)…

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Heart failure with mildly reduced ejection fraction (HFmrEF) | Heart failure with preserved ejection fraction (HFpEF) | Systemic inflammation
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-11-2023
First CTIS Authorization Date
15-03-2024

Trial design

Randomised, placebo (ziltivekimab c) versus ziltivekimab s.c. once-monthly (placebo described as "placebo (ziltivekimab c)"; dose not specified in provided documents).-controlled Phase III trial in France, Greece, Bulgaria and others.

Randomised
Yes
Comparator
Placebo (ziltivekimab C) versus ziltivekimab s.c. once-monthly (placebo described as "Placebo (ziltivekimab C)"; dose not specified in provided documents).
Target Sample Size
362
Trial Duration For Participant
365

Eligibility

Recruits 362 No vulnerable population selected. Standard written informed consent is required from participants prior to any study procedures; no assent or parental consent procedures for minors are described..

Vulnerable Population
No vulnerable population selected. Standard written informed consent is required from participants prior to any study procedures; no assent or parental consent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- Serum hs-CRP 2 mg/L at screening (visit 1).\n- NT-proBNP ≥ 225 pg/mL (375 pg/mL for patients with atrial fibrillation/flutter) at screening.\n- Diagnosis of heart failure (NYHA Class II-III).\n- LVEF > 40% documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g. MI or HF hospitalisation).\n- Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following: a) LA volume index > 34mL/m2 b) LA diameter ≥ 3.8cm c) LA length ≥ 5.0cm d) LA area ≥ 20cm2 e) LA volume ≥ 55mL f) Intraventricular septal thickness ≥ 1.1cm g) Posterior wall thickness ≥ 1.1cm h) LV mass index ≥ 115g∕m2 in men or ≥ 95 g∕m2 in women i) E/e’ (mean septal and lateral) ≥ 10 j) e’ (mean septal and lateral) < 9cm/s\n- No heart failure hospitalisations or urgent heart failure visits between screening and randomisation.\n- Able to perform the 6MWT at screening with a minimum distance of 100 metres. (NOTE: Patients are not eligible if any disease or condition, rather than HF, constitutes the main reason for limiting the ability to exercise/reduces exercise capacity).\n- KCCQ clinical summary score < 80 at screening"}

Exclusion criteria

  • {"criterion_text":"- Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1).\n- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.\n- Systolic blood pressure ≥180 mmHg at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving ≥3 antihypertensive drugs. (NOTE: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).\n- Heart rate above 110 or below 40 beats per minute as evaluated on the ECG performed at screening (visit 1). (NOTE: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).\n- Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (NOTE: Planned coronary angiogram is not exclusionary).\n- Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1).\n- Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).\n- Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease.\n- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.\n- Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary: Change in KCCQ clinical summary score (KCCQ-CSS) from randomisation (month 0) to end-of-treatment (month 12) (Score (score on scale; range; 0-100))","definition_or_measurement_approach":"Change in KCCQ clinical summary score (KCCQ-CSS) measured from randomisation (month 0) to end-of-treatment (month 12); score on scale range 0-100"}

Secondary endpoints

  • {"endpoint_text":"- Confirmatory secondary: Change in six-minute walk distance (6MWD) from randomisation (month 0) to end-of-treatment (month 12) (Metres)","definition_or_measurement_approach":"Change in 6MWD (metres) from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Change in hs-CRP from randomisation (month 0) to end-of-treatment (month 12) (Ratio to baseline)","definition_or_measurement_approach":"Change in hs-CRP ratio to baseline from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Participants experiencing improvement in NYHA Class (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participant)","definition_or_measurement_approach":"Count of participants with improvement in NYHA class (yes/no) from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Change in NT-proBNP from randomisation (month 0) to end-of-treatment (month 12) (Ratio to baseline)","definition_or_measurement_approach":"Change in NT-proBNP ratio to baseline from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Change in eGFR (CKD-EPI) from randomisation (month 0) to end-of-treatment (month 12) (mL/min/1.73 m2)","definition_or_measurement_approach":"Change in eGFR (CKD-EPI) in mL/min/1.73 m2 from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Participants achieving threshold for meaningful within- patient change in KCCQ-CSS (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants)","definition_or_measurement_approach":"Count of participants achieving predefined meaningful within-patient change threshold in KCCQ-CSS from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Participants achieving threshold for meaningful within- patient change in 6MWD (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants)","definition_or_measurement_approach":"Count of participants achieving predefined meaningful within-patient change threshold in 6MWD from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Participants improving 5 points or more in KCCQ-CSS (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants)","definition_or_measurement_approach":"Count of participants with ≥5 point improvement in KCCQ-CSS from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Participants improving 10 points or more in KCCQ-CSS (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants)","definition_or_measurement_approach":"Count of participants with ≥10 point improvement in KCCQ-CSS from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Change in KCCQ overall summary score (KCCQ-CCS) from randomisation (month 0) to end-of-treatment (month 12) (Score (score on scale; range 0-100))","definition_or_measurement_approach":"Change in KCCQ overall summary score from randomisation to month 12; score range 0-100"}
  • {"endpoint_text":"- Supportive secondary: Participants experiencing deterioration in NYHA class (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants)","definition_or_measurement_approach":"Count of participants with deterioration in NYHA class from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Change in KCCQ total symptom score from randomisation (month 0) to end-of-treatment (month 12) (Score, range 0-100)","definition_or_measurement_approach":"Change in KCCQ total symptom score (0-100) from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Change in KCCQ physical limitations score from baseline (month 0) to end-of-treatment (month 12) (Score, range 0-100)","definition_or_measurement_approach":"Change in KCCQ physical limitations score (0-100) from baseline to month 12"}
  • {"endpoint_text":"- Supportive secondary: Change in KCCQ social limitations score from randomisation (month 0) to end-of-treatment (month 12) (Score, range 0-100)","definition_or_measurement_approach":"Change in KCCQ social limitations score (0-100) from randomisation to month 12"}
  • {"endpoint_text":"- Supportive secondary: Change in KCCQ health-related quality of life score from randomisation (month 0) to end-of-treatment (month 12) (Score, range 0-100)","definition_or_measurement_approach":"Change in KCCQ health-related quality of life score (0-100) from randomisation to month 12"}

Recruitment

Digital Remote Recruitment
True, digital advertisements and digital recruitment materials are explicitly listed (country-specific digital ads).
Planned Sample Size
362
Recruitment Window Months
33
Consent Approach
Written informed consent obtained from each participant prior to any study procedures. Subject information and informed consent forms (L1 documents) are available in multiple language versions (including English, French, Greek, Bulgarian, Polish, Spanish, Czech, German and country-specific versions). No assent/parental consent procedures for minors are described.

Methods

  • Digital advertisements (country-specific digital ads listed for multiple countries: France, Greece, Spain, Poland, Germany, Czechia, Bulgaria).
  • Posters displayed in clinical settings (country-specific poster materials listed).
  • Trifold leaflets/brochures for patient recruitment (country-specific).
  • Patient study booklet / 'Other Info to Subjects' materials provided to potential participants.
  • Site-based recruitment via participating hospitals and cardiology clinics (trial sites listed in each country).
  • Recruitment arrangements and informed consent procedures documented in K1 / SI-IC documents (country-specific versions).

Geography

Total Number Of Sites
67
Total Number Of Participants
318

France

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
15-03-2024
Processing Time Days
23
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Polyclinique Vauban
Contact Person Name
Sébastien Caudmont
Contact Person Email
sebastien.caudmont@elsan.care
Site Name
Centre Hospitalier Universitaire De Rennes
Contact Person Name
Erwan Donal
Contact Person Email
Erwan.DONAL@chu-rennes.fr
Site Name
CHRU De Nancy
Contact Person Name
Nicolas GIRERD
Contact Person Email
n.girerd@chru-nancy.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Contact Person Name
Fabrice Ivanes
Contact Person Email
f.ivanes@chu-tours.fr
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Contact Person Name
Jean-Michel Tartière
Site Name
Centre Hospitalier Universitaire De Poitiers
Contact Person Name
Claire BOULETI
Contact Person Email
Claire.BOULETI@chu-poitiers.fr

Greece

Earliest CTIS Part Ii Submission Date
07-12-2023
Latest Decision Or Authorization Date
26-03-2024
Processing Time Days
110
Number Of Sites
14
Number Of Participants
55

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Cardiology department
Contact Person Name
Ioannis Zarifis
Contact Person Email
zarifis.john@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Cardiology department
Contact Person Name
Grigorios Giamouzis
Contact Person Email
grgiamouzis@gmail.com
Site Name
Alexandra Hospital
Department Name
Department of Clinical Therapeutics
Contact Person Name
Alexandros Briasoulis
Contact Person Email
alexbriasoulis@gmail.com
Site Name
Athens Naval Hospital
Department Name
Cardiology department
Contact Person Name
Anastasios Milkas
Contact Person Email
tmhlkas@otenet.gr
Site Name
General Hospital Of Chios Skylitseio
Department Name
Cardiology Department and Cath Lab
Contact Person Name
Athanasios Kartalis
Contact Person Email
thkartal@otenet.gr
Site Name
General Hospital Of Athens G Gennimatas
Department Name
Cardiology Department
Contact Person Name
Apostolos Karavidas
Contact Person Email
cardiology@gna-gennimatas.gr
Site Name
General Hospital Of Nea Ionia Konstantopouleio Patision
Department Name
Cardiology department
Contact Person Name
Sotirios Patsilinakos
Contact Person Email
spatsilinakos@gmail.com
Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
1st Cardiology Clinic
Contact Person Name
Evdokia Petropoulou
Contact Person Email
evdokiapetropoulou@yahoo.gr
Site Name
University General Hospital Attikon
Department Name
B' Cardiology department
Contact Person Name
Gerasimos Filippatos
Contact Person Email
gfilippatos@gmail.com
Site Name
Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.
Department Name
6th Cardiology Clinic
Contact Person Name
Elias Tsougos
Contact Person Email
ITsougkos@hygeia.gr
Site Name
Evangelismos S.A.
Department Name
2nd Cardiology Department
Contact Person Name
Sotirios Xydonas
Contact Person Email
sotxyd@gmail.com
Site Name
Sismanogleio General Hospital
Department Name
Cardiology department & Intensive Cardiac Care Unit
Contact Person Name
Anastasia Kitsiou
Contact Person Email
anastasia.kitsiou@gmail.com
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
A' Cardiology Clinic
Contact Person Name
Georgios Giannakoulas
Contact Person Email
g.giannakoulas@gmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
Cardiology Department
Contact Person Name
Costas Thomopoulos
Contact Person Email
thokos@laiko.gr

Bulgaria

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
10
Number Of Sites
10
Number Of Participants
65

Sites

Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Department of Cardiology
Contact Person Name
Yordan Dzhumean
Contact Person Email
jordan.jumean@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of Cardiology
Contact Person Name
Maria Milanova
Contact Person Email
milanovamaria@abv.bg
Site Name
Medical Center Isul Tsaritsa Yoanna EOOD
Contact Person Name
Elena Kinova
Contact Person Email
kinova.e@abv.bg
Site Name
University Hospital St. Anna
Department Name
Department of General Cardiology, part of Clinic of cardiology.
Contact Person Name
Arman Postadzhiyan
Contact Person Email
armanp@abv.bg
Site Name
Medical Center Medicabilis Ltd.
Contact Person Name
Ivaylo Ivanov
Contact Person Email
ivaylo_p_ivanov@abv.bg
Site Name
Medical Centre Synexus Sofia EOOD
Contact Person Name
Ivaylo Ivanov
Contact Person Email
ivaylo_p_ivanov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Department of cardiology
Contact Person Name
Mariya Tokmakova
Contact Person Email
m14021971@yahoo.co.uk
Site Name
Medical Center Hera EOOD
Contact Person Name
Ralitsa Pancheva
Site Name
Multidisciplinary Hospital For Active Treatment Haskovo AD
Department Name
Department of cardiology
Contact Person Name
Ivaylo Vasilev
Contact Person Email
ivovassilevmd@yahoo.com
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
First department of cardiology
Contact Person Name
Iana Simova
Contact Person Email
ianasimova@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
33
Number Of Sites
18
Number Of Participants
75

Sites

Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Kardiologiczny
Contact Person Name
Grzegorz Piotrowski
Contact Person Email
g.piotrowski@kopernik.lodz.pl
Site Name
Centrum Medyczne Intercor Sp. z o.o.
Contact Person Name
Grzegorz Grześk
Contact Person Email
ggrzesk@cm.umk.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
Department Name
Odział Kardiologii i Chorób Wewnętrznych
Contact Person Name
Jacek Gniot
Contact Person Email
jacekgniot1@gmail.com
Site Name
Linden Sp. z o.o. sp.k.
Contact Person Name
Piotr Paluszek
Contact Person Email
piotr.paluszek@cmlinden.com
Site Name
Cardiomedicum Sp. z o.o.
Contact Person Name
Edyta Stodółkiewicz-Nowarska
Contact Person Email
e.nowarska@cardiomedicum.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Kardiologii Inwazyjnej, Pododdzial Niewydolnosci Serca i Transplantologii
Contact Person Name
Agnieszka Pawlak
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddzial Kardiologii
Contact Person Name
Ewa Straburzynska-Migaj
Site Name
American Heart Of Poland S.A.
Department Name
Centrum Kardiologii i Kardiochirurgii
Contact Person Name
Krzysztof Milewski
Contact Person Email
krzysztof.milewski@ahop.pl
Site Name
Indywidualna Specjalistyczna Praktyka Lekarska W Dziedzinie Kardiologii Lek Med. Krzysztof Cymerman
Contact Person Name
Krzysztof Cymerman
Contact Person Email
cym@interia.eu
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ
Department Name
Zaklad Kardiologii Nieinwazyjnej, Poradnia Kardiologiczna
Contact Person Name
Malgorzata Lelonek
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclaw
Contact Person Name
Bartosz Krakowiak
Contact Person Email
bartek.krakowiak@gmail.com
Site Name
Zanamed Medical Clinic Sp. z o.o.
Contact Person Name
Aneta Skwarek-Dziekanowska
Contact Person Email
anetask@gmail.com
Site Name
Formed 2 Sp. z o.o.
Contact Person Name
Grazyna Mach
Contact Person Email
grazyna.mach@nzozformed2.pl
Site Name
American Heart Of Poland S.A.
Department Name
X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji
Contact Person Name
Adam Janas
Contact Person Email
adam.janas@ahop.pl
Site Name
Prywatna Praktyka Lekarska Anna Chudoba
Contact Person Name
Anna Chudoba
Contact Person Email
anna.chudoba@kardiogabinet.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Kardiologii, Lipidologii i Chorob Wewnetrznych z oddzialem Intensywnego Nadzoru Kardiologic
Contact Person Name
Anna Tomaszuk-Kazberuk
Contact Person Email
a.tomaszuk@poczta.fm
Site Name
Trialmed Sp. z o.o.
Department Name
Trialmed CRS
Contact Person Name
Ewa Kalecińska-Krystkiewicz
Contact Person Email
e.krystkiewicz@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
40
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Contact Person Name
Andreas Hagenow
Contact Person Email
a.hagenow@zks-sbb.com
Site Name
Herzzentrum Dresden GmbH Universitaetsklinik
Contact Person Name
Ephraim Winzer
Contact Person Email
ephraim.winzer@tu-dresden.de
Site Name
MVZ CCB Frankfurt Und Main-Taunus GbR
Contact Person Name
Holger Eggebrecht
Contact Person Email
h.eggebrecht@ccb.de
Site Name
Universitaet Des Saarlandes
Contact Person Name
Insa Emrich
Contact Person Email
Insa.emrich@uks.eu
Site Name
MVZ im Altstadt-Carree Fulda GmbH
Contact Person Name
Jörg Simon
Contact Person Email
simon.fulda@t-online.de
Site Name
Kardiopraxis Schirmer
Contact Person Name
Stephan H Schirmer
Site Name
Medical Center - University Of Freiburg
Contact Person Name
Dennis Wolf

Spain

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
55
Number Of Sites
7
Number Of Participants
55

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Contact Person Name
Pau LLacer Iborra
Contact Person Email
pau.llacer@salud.madrid.org
Site Name
Hospital General Universitario Gregorio Maranon
Contact Person Name
Manuel Martínez- Sellés
Contact Person Email
mmselles@secardiologia.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Contact Person Name
Esther Montero Hernández
Site Name
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Contact Person Name
Clara Bonanad Lozano
Contact Person Email
clarabonanad@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Contact Person Name
José Ramón González Juanatey
Site Name
Hospital Virgen Del Camino
Contact Person Name
Alejandro López Suárez
Contact Person Email
a.lopez.ssl@gmail.com
Site Name
Hospital Nisa Sevilla Aljarafe
Contact Person Name
Cristobal Morales Portillo
Contact Person Email
cr.morales@hotmail.com

Czechia

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
18-03-2024
Processing Time Days
31
Number Of Sites
5
Number Of Participants
35

Sites

Site Name
Kardiologicka ambulance Brno s.r.o.
Contact Person Name
Jiri Parenica
Contact Person Email
jiri.parenica@atlas.cz
Site Name
MEDICON a.s.
Contact Person Name
Jan Mácha
Contact Person Email
jan.macha@mediconas.cz
Site Name
Vojenska Nemocnice Brno
Contact Person Name
Roman Miklik
Contact Person Email
romanmiklik@yahoo.com
Site Name
Nemocnice AGEL Trinec-Podlesi a.s.
Contact Person Name
Alexandra Vodzinská
Contact Person Email
avodzinska@volny.cz
Site Name
Innera s.r.o.
Contact Person Name
Jitka Průchová
Contact Person Email
Jitka9@centrum.cz

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Name
4G Clinical B.V.
Responsibilities
RTSM Supplier
Name
Oracle Danmark ApS
Responsibilities
Provider of ARGUS service

Third parties

  • {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"Provider of ARGUS service","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Colorado Prevention Center","duties_or_roles":"6 minutes walking test","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM Supplier","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA Supplier","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"International Drug Development Institute","duties_or_roles":"External independent statistical service provider","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"CRF supplier","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ziltivekimab
Active Substance
ZILTIVEKIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Frequency
Once-monthly
Investigational Product Name
Placebo (ziltivekimab C)
Modality
Other
Combination Treatment
Yes

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