Clinical trial • Phase II|Phase IV • Cardiology

CORAMITUG for Transthyretin amyloid cardiomyopathy (ATTR-CM)

Phase II|Phase IV trial of CORAMITUG for Transthyretin amyloid cardiomyopathy (ATTR-CM). open-label. 31 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Transthyretin amyloid cardiomyopathy (ATTR-CM)
Trial Stage
Phase II|Phase IV
Drug Modality
Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
05-02-2024
First CTIS Authorization Date
29-05-2024

Trial design

open-label Phase II|Phase IV trial in Italy, Netherlands, Czechia and others.

Open Label
Yes
Target Sample Size
31
Trial Duration For Participant
1092

Eligibility

Recruits 31 Vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Informed consent must be obtained before any study-related activities. Subject information and informed consent forms (SI-IC) and related materials are provided (multiple documents listed, including adult main, future research, male partner, privacy, patient ID card). No specific assent process for minors is provided in the available documentation..

Pregnancy Exclusion
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method, as defined in Appendix 4 (Section ‎10.4). Spain: For country-specific requirements, please refer to Appendix 8 (Section ‎10.8).
Vulnerable Population
Vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Informed consent must be obtained before any study-related activities. Subject information and informed consent forms (SI-IC) and related materials are provided (multiple documents listed, including adult main, future research, male partner, privacy, patient ID card). No specific assent process for minors is provided in the available documentation.

Inclusion criteria

  • {"criterion_text":"- Informed consent 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- Completed study intervention in NN6019-4940 (a) and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16. (a)- A participant who has not permanently discontinued study intervention as defined in NN6019-4940\n- Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit."}

Exclusion criteria

  • {"criterion_text":"- Known or suspected hypersensitivity to study intervention(s) or related products.\n- Aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 2.5 × the upper limit of normal (ULN) or total bilirubin ≥ 2 × ULN at screening.\n- Body weight > 120 kg (264.6 lb) at screening.\n- International normalised ratio (INR)>1.5 (unless participant is on anticoagulant therapy, in which case excluded if INR>3.5).\n- Previous enrolment in this study.\n- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method, as defined in Appendix 4 (Section ‎10.4). Spain: For country-specific requirements, please refer to Appendix 8 (Section ‎10.8).\n- Use of another approved or non-approved investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (whichever is longer) before screening, except study intervention used in study NN6019-4940\n- Participation (i.e., signed informed consent) in any interventional clinical study from visit 16 (week 64) in NN6019-4940 until visit 1 (screening) in the current study NN6019-7565.\n- Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.\n- A prior solid organ transplant.\n- Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia or low-grade prostate cancer) within 5 years before screening.\n- Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of treatment emergent adverse events from baseline (week 0) up to visit 39 (week 156)","definition_or_measurement_approach":"Count of treatment-emergent adverse events recorded from baseline (week 0) through visit 39 (week 156)."}

Secondary endpoints

  • {"endpoint_text":"- Change in 6-minute walk test (6MWT) from baseline (week 0) to visit 28 (week 104)","definition_or_measurement_approach":"Change in distance walked during the 6-minute walk test between baseline (week 0) and visit 28 (week 104)."}
  • {"endpoint_text":"- Change in NT-proBNP from baseline (week 0) to visit 28 (week 104)","definition_or_measurement_approach":"Change in NT-proBNP biomarker level from baseline (week 0) to visit 28 (week 104)."}
  • {"endpoint_text":"- Change in myocardial extracellular volume from baseline (week 0) to visit 28 (week 104)","definition_or_measurement_approach":"Change in myocardial extracellular volume (imaging-derived) from baseline (week 0) to visit 28 (week 104)."}
  • {"endpoint_text":"- Change in KCCQ-(CSS)2 from baseline (week 0) to visit 28 (week 104)","definition_or_measurement_approach":"Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-(CSS)2) score from baseline (week 0) to visit 28 (week 104)."}
  • {"endpoint_text":"- Change in troponin I from baseline (week 0) to visit 28 (week 104)","definition_or_measurement_approach":"Change in troponin I biomarker level from baseline (week 0) to visit 28 (week 104)."}
  • {"endpoint_text":"- Change in GLS on echocardiography from baseline (week 0) to visit 28 (week 104)","definition_or_measurement_approach":"Change in global longitudinal strain (GLS) measured by echocardiography from baseline (week 0) to visit 28 (week 104)."}

Recruitment

Planned Sample Size
31
Recruitment Window Months
43
Consent Approach
Informed consent must be obtained before any study-related activities. Subject information and informed consent forms (SI-IC) are provided (adult main, future research, male partner, privacy, patient ID card and other materials). Multiple language versions of consent/information documents are available across countries (English, French, Italian, Spanish, Portuguese, Dutch, Czech, German as indicated by document translations). No specific assent process for minors is described.

Geography

Total Number Of Sites
13
Total Number Of Participants
58

Italy

Earliest CTIS Part Ii Submission Date
04-05-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
27
Number Of Sites
2
Number Of Participants
14

Sites

Site Name
Fondazione Toscana Gabriele Monasterio
Contact Person Name
Michele Emdin
Contact Person Email
emdin@ftgm.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Contact Person Name
Giovanni Palladini
Contact Person Email
giovanni.palladini@unipv.it

Netherlands

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
17
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Universitair Medisch Centrum Groningen
Contact Person Name
Peter van der Meer
Contact Person Email
p.van.der.meer@umcg.nl
Site Name
Universitair Medisch Centrum Utrecht
Contact Person Name
Marish Oerlemans

Czechia

Earliest CTIS Part Ii Submission Date
03-05-2024
Latest Decision Or Authorization Date
30-05-2024
Processing Time Days
27
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Contact Person Name
Tomas Palecek
Contact Person Email
Tomas.Palecek@lf1.cuni.cz

Spain

Earliest CTIS Part Ii Submission Date
21-03-2024
Latest Decision Or Authorization Date
30-05-2024
Processing Time Days
70
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Contact Person Name
Pablo García Pavía
Contact Person Email
pablogpavia@yahoo.es

France

Earliest CTIS Part Ii Submission Date
14-05-2024
Latest Decision Or Authorization Date
30-05-2024
Processing Time Days
16
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiology Department
Contact Person Name
Amira Zaroui
Contact Person Email
amira.zaroui@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Contact Person Name
Olivier LAIREZ
Contact Person Email
lairez.o@chu-toulouse.fr

Portugal

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
43
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
Contact Person Name
Olga Azevedo

Germany

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
30-05-2024
Processing Time Days
21
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Contact Person Name
Caroline Morbach
Contact Person Email
Morbach_C@ukw.de
Site Name
Klinikum der Universitaet Muenchen AöR
Contact Person Name
Stephanie Schwarting
Site Name
Universitaet Muenster
Contact Person Name
Ali Yilmaz
Contact Person Email
Ali.Yilmaz@ukmuenster.de
Site Name
Universitaetsklinikum Heidelberg AöR
Contact Person Name
Fabian aus dem Siepen

Sponsor

Primary sponsor

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

Contract research organisations

Name
Celerion Switzerland AG
Responsibilities
Special Laboratory for Antibodies samples
Name
Bioclinica Inc.
Responsibilities
Imaging Service
Name
Colorado Prevention Center
Responsibilities
Specialized vendor related to 6- Minute Walking Test (6MWT)
Name
4G Clinical B.V.
Responsibilities
RTSM/IWRS supplier
Name
Icon Clinical Research Limited
Responsibilities
Central Laboratory
Name
Oracle Corp.
Responsibilities
CRF supplier

Third parties

  • {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special Laboratory for Antibodies samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging Service","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Colorado Prevention Center","duties_or_roles":"Specialized vendor related to 6- Minute Walking Test (6MWT)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM/IWRS supplier","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Oracle Corp.","duties_or_roles":"CRF supplier","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
coramitug
Active Substance
CORAMITUG
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=1
Orphan Designation
Yes

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