A proof of concept and dose-finding study of XXB750 in patients with heart failure

Start 13 Mar 2024 · End 9 Nov 2024 · Status Ended · 11 EU/EEA countries · 119 sites · Protocol CXXB750A12201

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ended

Participants planned 740

Countries 11

Sites 119

Heart Failure

To evaluate the efficacy and dose-response relationship of three XXB750 target dose levels compared to placebo in reducing N-terminal prohormone B-type natriuretic peptide (NT-proBNP) from baseline to Week 16 in symptomatic HF patients with LVEF < 50% treated with standard of care, including ACEI/ARB or sacubitril/vals…

Key facts

Sponsor: Novartis Pharma AG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 13 Mar 2024 → 9 Nov 2024
Decision date (initial): 2024-03-11
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Novartis Pharma AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Dose response, Efficacy

Secondary objectives 3

To evaluate the treatment effect of the highest XXB750 target dose level compared to placebo in reducing NT-proBNP from baseline to Week 16 in symptomatic HF patients with LVEF <50% treated with standard of care, including ACEI/ARB or sacubitril/valsartan.
To evaluate the treatment effect of combined two highest XXB750 target dose levels administered in addition to a background of ACEI/ARB versus conversion from ACEI/ARB to sacubitril/valsartan, in reducing NT-proBNP from baseline to Week 16.
To evaluate the safety and tolerability of XXB750 up-titration regimens and dose levels.

Conditions and MedDRA coding

Heart Failure

Version	Level	Code	Term	System organ class
20.0	LLT	10019279	Heart failure	10007541

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

Written informed consent must be obtained before any assessment is performed.
Male and female outpatients who are ≥ 18 years old.
Symptom(s) of HF NYHA class II-III at Screening.
LVEF < 50% (most recent local measurement, made within 6 months prior to or during screening using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided no subsequent measurement ≥ 50%).
NT-proBNP ≥ 600 pg/ml if in sinus rhythm or  NT-proBNP ≥ 900 pg/ml if in atrial fibrillation/flutter at Screening.
Receiving an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks before Screening or receiving sacubitril/valsartan at a stable dose of at least 49/51 mg bid for at least 4 weeks before Screening.
Receiving other guideline recommended HF therapies as deemed appropriate by the investigator and that are stable for at least 4 weeks before Screening, unless contraindicated, not tolerated, or not available to patient.

Exclusion criteria 6

Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy) or hospitalization for HF within 3 months prior to screening.
Office systolic blood pressure (SBP) ≥ 180 mmHg or < 105 mmHg at screening or at randomization.
In subjects with ACEI/ARB medication at screening, previous inability to tolerate any dose of sacubitril/valsartan (as per the investigator's judgment).
Serum potassium > 5.4 mmol/L at screening.
Estimated GFR (eGFR) < 30 mL/min/1.73m2 at screening as measured by the CKD-EPI formula.
Known history of angioedema.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Change in log NT-proBNP from baseline to Week 16

Secondary endpoints 2

Change in log NT-proBNP from baseline to Week 16
Adverse events, safety laboratory parameters, and vital signs from baseline to end of study (EOS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

XXB750

PRD9783251 · Product

Active substance: XXB750
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 240 mg milligram(s)
Max total dose: 240 mg milligram(s)
Max treatment duration: 16 Week(s)
Authorisation status: Not Authorised
MA holder: NOVARTIS PHARMA AG
Paediatric formulation: No
Orphan designation: No

Comparator 1

Valsartan

SCP8263247 · ATC

Active substance: Valsartan
Route of administration: ORAL USE
Max daily dose: 400 mg milligram(s)
Max total dose: 400 mg milligram(s)
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09DX04 — VALSARTAN AND SACUBITRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Placebo 1

0 mg/1 mL Placebo to XXB750 150 mg/1 mL concentrate for solution for injection

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Auxiliary 22

Losartan Potassium

SCP1083046 · ATC

Active substance: Losartan Potassium
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09CA01 — LOSARTAN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Azilsartan Medoxomil

SCP180104 · ATC

Active substance: Azilsartan Medoxomil
Substance synonyms: TAK-491
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09CA09 — AZILSARTAN MEDOXOMIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Valsartan

SCP131775 · ATC

Active substance: Valsartan
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09CA04 — IRBESARTAN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hydrochlorothiazide

SCP136623 · ATC

Active substance: Hydrochlorothiazide
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09CA07 — TELMISARTAN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Eprosartan Mesilate

SCP162949 · ATC

Active substance: Eprosartan Mesilate
Substance synonyms: EPROSARTAN MESYLATE, 4-[[2-BUTYL-5-[(E)-2-CARBOXY-3-THIOPHEN-2-YL-PROP-1-ENYL]IMIDAZOL-1-YL]METHYL]BENZOIC ACID: METHANESULFONIC ACID
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09CA02 — EPROSARTAN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Olmesartan Medoxomil

SCP132986 · ATC

Active substance: Olmesartan Medoxomil
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09CA08 — OLMESARTAN MEDOXOMIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Candesartan

SCP128457 · ATC

Active substance: Candesartan
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09CA06 — CANDESARTAN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Valsartan

SCP1000156 · ATC

Active substance: Valsartan
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09CA03 — VALSARTAN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cilazapril

SCP136325 · ATC

Active substance: Cilazapril
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA08 — CILAZAPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trandolapril

SCP146035 · ATC

Active substance: Trandolapril
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA10 — TRANDOLAPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Perindopril Tert-Butylamine

SCP126600 · ATC

Active substance: Perindopril Tert-Butylamine
Substance synonyms: PERINDOPRIL ERBUMINE
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA04 — PERINDOPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Lisinopril Dihydrate

SCP1138921 · ATC

Active substance: Lisinopril Dihydrate
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA03 — LISINOPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hydrochlorothiazide

SCP10361725 · ATC

Active substance: Hydrochlorothiazide
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA05 — RAMIPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Zofenopril Calcium

SCP189600 · ATC

Active substance: Zofenopril Calcium
Substance synonyms: Zofenopril hemicalcium
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA15 — ZOFENOPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enalapril Maleate

SCP129505 · ATC

Active substance: Enalapril Maleate
Substance synonyms: Enalapril hydrogen maleate
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA02 — ENALAPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP1140493 · ATC

Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA07 — BENAZEPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imidapril Hydrochloride

SCP161869 · ATC

Active substance: Imidapril Hydrochloride
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA16 — IMIDAPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP211111 · ATC

Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA13 — MOEXIPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Captopril

SCP128193 · ATC

Active substance: Captopril
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA01 — CAPTOPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fosinopril Sodium

SCP129020 · ATC

Active substance: Fosinopril Sodium
Substance synonyms: SODIUM (2S,4S)-4-CYCLOHEXYL-1-[2-[(2-METHYL-1-PROPANOYLOXY-PROPOXY)-(4-PHENYLBUTYL)PHOSPHORYL]ACETYL]PYRROLIDINE-2-CARBOXYLATE
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA09 — FOSINOPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP217314 · ATC

Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA12 — DELAPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Quinapril Hydrochloride

SCP1166632 · ATC

Active substance: Quinapril Hydrochloride
Route of administration: ORAL USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: C09AA06 — QUINAPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation: Novartis Pharma AG
Address: Lichtstrasse 35
City: Basel Town
Postcode: 4056
Country: Switzerland

Scientific contact point

Organisation: Novartis Pharma AG
Contact name: Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation: Novartis Pharma AG
Contact name: Novartis Pharma Arzneimittel GmbH

Third parties 24

Organisation	City, country	Duties
World Courier Bulgaria Ltd ORL-000001024	Sofia, Bulgaria	Other
Somalogic Operating Co. Inc. ORG-100042788	Boulder, United States	Other
Icon Clinical Research Limited ORG-100008322	Dublin 18, Ireland	On site monitoring
SGS France ORG-100011566	Saint Benoit, France	Other
Medpace Reference Laboratories LLC ORG-100041727	Cincinnati, United States	Other
Specific Pharma A/S ORG-100015041	Copenhagen Sv, Denmark	Code 14, Other
Longboat Clinical Limited ORG-100045828	Limerick, Ireland	Other
Lonza AG ORG-100011548	Stein Ag, Switzerland	Other
S & D Pharma Logistics BG EOOD ORG-100017521	Sofia, Bulgaria	Other
Syneos Health Inc. ORG-100008382	Morrisville, United States	On site monitoring
Medidata Solutions Inc. ORG-100016256	New York, United States	Data management, E-data capture
RWS Life Sciences Inc. ORG-100042348	East Hartford, United States	Other
Medpace Singapore Pte. Ltd ORL-000003294	Singapore	Other
Parexel International (IRL) Limited ORG-100022780	Dublin 2, Ireland	Code 12
Creapharm Clinical Supplies ORG-100020131	Reims, France	Other
Jumo Health USA Inc. ORG-100044054	New Haven, United States	Other
Medical Equipment Supplies And Management Limited ORG-100044212	Chorley, United Kingdom	Other
Tjoapack Netherlands B.V. ORG-100011583	Etten-Leur, Netherlands	Other
Medpace, Reference Laboratories ORL-000003424	Shanghai, China	Other
MEDPACE LABORATORIES ORG-100042942	Leuven, Belgium	Other
Eurofins Genomics Europe Genotyping A/S ORG-100044656	Galten, Denmark	Other
Movianto Slovensko s.r.o. ORG-100020628	Senec, Slovakia	Code 14, Other
Alloga (Nederland) B.V. ORG-100021718	Veghel, Netherlands	Other
IQVIA Limited ORG-100008655	Reading, United Kingdom	On site monitoring, Other, Interactive response technologies (IRT)

Locations

11 EU/EEA countries · 119 investigational sites

By country

Country	MS status	Planned subjects	Sites
Bulgaria	Ended	48	10
Czechia	Ended	70	8
Denmark	Ended	18	5
France	Ended	40	13
Germany	Ended	60	25
Hungary	Ended	35	10
Italy	Ended	45	16
Netherlands	Ended	18	6
Portugal	Ended	12	4
Slovakia	Ended	33	8
Spain	Ended	45	14
Rest of world Japan, United Kingdom, China, Taiwan, Brazil, South Africa, United States, India	—	316	—

Investigational sites

Bulgaria

10 sites · Ended

University Hospital St Marina Varna

#3008:First Cardiology Clinic, Hristo Smirnenski St 1, 9010, Varna

National Multidisciplinary Transport Hospital Tsar Boris III

#3001:Clinic of Cardiology, Bulevard Knyaginya Mariya Luiza 104, 1233, Sofia

Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD

#3002:Department of cardiology, Ulitsa Slavyanska 62, 2700, Blagoevgrad

Medical Center New Polyclinic Gabrovo Ltd.

#3003, Mogilev 52a, 5300, Gabrovo

Medical Center Dea Medicals EOOD

#3004, Ulitsa Hristo Botev 51, 2500, Kyustendil

University Hospital St. Anna

#3007:Clinic of Cardiology, Ulitsa Dimitir Mollov 1, 1750, Sofiya

Medical Center Medconsult Pleven OOD

#3009, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven

Medical Center Hera EOOD

#3010, Ulitsa Klisura 20, 1510, Sofiya

University Multiprofile Hospital For Active Treatment Saint Georgi EAD

#3006:Clinic of Cardiology, Bulevard Peshtersko Shose 66, 4002, Plovdiv

Medical Center Zara-Med EOOD

#3005, Ulitsa Orfey 4, 6003, Stara Zagora

Czechia

8 sites · Ended

KardioBusak s.r.o.

3051:Interní a kardiologická ambulance, Kosmonautu 2303, 440 01, Louny

Fakultni Nemocnice Plzen

3052:Kardiologická klinika, Alej Svobody 923/80, 323 00, Plzen 23

Vseobecna Fakultni Nemocnice V Praze

3053:II. interní klinika kardiologie a angiologie, U Nemocnice 499/2, Nove Mesto, Prague

Krajska nemocnice Liberec a.s.

3054:Kardiocentrum, Husova 357/10, Liberec I-Stare Mesto, Liberec (neclenene Mesto)

Oblastni nemocnice Kolin a.s. nemocnice Stredoceskeho kraje

3055:Interní oddělení, Zizkova 146, 280 02, Kolin III

Institute For Clinical And Experimental Medicine

3056:Oddělení srdečního selhání, Videnska 1958/9 Krc, 140 00, Prague

MUDr. Libor Nechvatal s.r.o.

3057:Kardiologická ambulance, Hybesova 289/43, Stare Brno, Brno-Stred

Fakultni Nemocnice Kralovske Vinohrady

3058:Kardiologická klinika, Srobarova 1150/50, Vinohrady, Prague

Denmark

5 sites · Ended

Region Sjaelland

#3151:Kardiologisk Afdeling - Kardiologisk Forsknings Enhed, Sygehusvej 10, 4000, Roskilde

Gentofte Hospital

#3152:Hjertemedicinsk Forskning, klinik 1, Gentofte Hospitalsvej 1, 2900, Hellerup

Aarhus Universitetshospital

#3153:Kardiologisk Medicin B, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Hvidovre Hospital

#3154:Kardiologisk ambulatorie 259 opg. 2, Kettegaard Alle 30, 2650, Hvidovre

Slagelse Hospital

#3155:Ambulatorium for hjertesygdomme, Ingemannsvej 18, 4200, Slagelse

France

13 sites · Ended

Centre Hospitalier Universitaire Grenoble Alpes

3107: Cardiologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9

Centre Hospitalier Regional Universitaire De Tours

3103: Cardiologie, Avenue De La Republique, 37170, Chambray Les Tours

Centre Hospitalier Universitaire De Nantes

3105: Cardiologie et maladies vasculaires, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain

Hospices Civils De Lyon

3102: Centre d’Investigation Clinique, 59 Boulevard Pinel, 69500, Bron

Centre Hospitalier Universitaire De Montpellier

3108: USIC (Unité de Soins Intensifs en Cardiologie), 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Centre Hospitalier Universitaire De Rennes

3111: Service de Cardiologie et Maladies Vasculaires, 2 Rue Henri Le Guilloux, 35000, Rennes

Bicetre Hospital

3109: Cardiologie, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex

Assistance Publique Hopitaux De Paris

3110: Cardiologie, 2 Rue Ambroise Pare, 75010, Paris

Centre Hospitalier De Beziers

3104: Service de Cardiologie, Zone Dactivite Montimaran, 2 Rue Valentin Hauy, Beziers

Centre Hospitalier Universitaire De Toulouse

3101: Cardiologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9

CHU De Rouen

3116: Cardiologie, 1 Rue De Germont, Bp 96031, Rouen Cedex

Centre Hospitalier Universitaire De Poitiers

3106: Cardiologie, 2 Rue De La Miletrie, 86000, Poitiers

Assistance Publique Hopitaux De Paris

3112: Cardiologie, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil

Germany

25 sites · Ended

Klinische Forschung Hannover-Mitte GmbH

#3239, Schillerstrasse 30, Mitte, Hanover

Klinische Forschung Schwerin GmbH

#3240, Friedrichstrasse 1, Altstadt, Schwerin

Klinische Forschung Dresden GmbH

#3236, Prager Strasse 10, Seevorstadt-Ost/Grosser Garten, Dresden

Klinische Forschung Hamburg GmbH

#3238, Hoheluftchaussee 18, Hoheluft-Ost, Hamburg

Klinik am See

#3242:Klinik für Innere Medizin / Kardiologie, Seebad 84, 15562, Rüdersdorf bei Berlin

Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH

#3224:Zentrum für klinische Prüfungen, Forststrasse 3, Radeberger Vorstadt, Dresden

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

#3222:Klinik für Kardiologie, Pneumologie, Angiologie und Internistische Intensivmedizin, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein

Praxis Dr. Markus Knapp

#3230:Praxis, Weiler Wiese 5, 74523, Schwäbisch Hall

Velocity Clinical Research GmBH

#3210:Klinische Forschung Berlin, Ansbacher Strasse 17-19, Schoeneberg, Berlin

Universitätsklinikum des Saarlandes

#3229:Klinik für Innere Medizin III, Klinik für Innere Medizin III Kirrberger Str.100 Homburg/Saar, 66421, Homburg

Medical Center - University Of Freiburg

#3225:Klinik für Kardiologie und Angiologie, Suedring 15, 79189, Bad Krozingen

Praxis für Innere Medizin Kardiologie Pneumologie

#3207:Praxis für Innere Medizin Kardiologie Pneumologie, Wiener Platz 5, 51065, Cologne

Herzzentrum Dresden GmbH Universitaetsklinik

#3211:Innere Medizin und Kardiologie, Fetscherstrasse 76, Johannstadt-Nord, Dresden

Robert Bosch Gesellschaft fuer medizinische Forschung mbH

#3227:Kardiologie, Auerbachstrasse 112, Bad Cannstatt, Stuttgart

ClinPhenomics CVC GmbH

#3209:Studienzentrum Frankfurt, Schaumainkai 101-103, Sachsenhausen, Frankfurt Am Main

Herzzentrum Leipzig GmbH

#3223:Kardiologie, Struempellstrasse 40a, Probstheida, Leipzig

Studienzentrum Bocholder Straße

#3220:Praxis, Bocholderstr 158, 45355, Essen

Dr. med. Andreas Wilke Dr. med. Andrej Malazhavy und Detelin Lalev Denchev Fachaerzte Innere Medizin und Kardiologie Partnerschaft

#3218:Praxis, Hauptkanal Links 100, Papenburg-Untenende, Papenburg

Marienhaus Klinikum St. Elisabeth Neuwied

#3203, Friedrich-Ebert-Strasse 59, 56564, Neuwied

Klinikum Coburg GmbH

#3215:Innere Medizin und Kardiologie, Ketschendorfer Strasse 33, 96450, Coburg

Goethe University Frankfurt

#3216:Universitaetsklinikum Frankfurt Medizinische Klinik 3 / Kardiologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main

Universitaetsklinikum Schleswig-Holstein

#3214:Klinik für Innere Medizin III Kardiologie, Angiologie und internistische Intensivmedizin, Arnold-Heller-Strasse 3, Brunswik, Kiel

Hausarztzentrum Butendorf

#3202, Horster Strasse 137, Butendorf, Gladbeck

Praxis Dr. Toursarkissian

#3212:Praxis, Heinz-Galinski-Str. 1, 13347, Berlin

Praxis fuer Gastroenterologie im Haus der Gesundheit Ludwigshafen

#3204:Praxis, Leiningerstr. 49-53, 67067, Ludwigshafen

Hungary

10 sites · Ended

TaNa Med Kft.

3256, Hunyadi Janos Utca 14, 9200, Mosonmagyarovar

University Of Pecs

3257: I sz Belgyogyaszati Klinika, Ifjusag Utja 13, 7624, Pecs

Studium Egeszseghaz Kft.

3258, Szechenyi Ut 16 Fsz. 1, 6300, Kalocsa

University Of Debrecen

3254: Kardiologiai es Szivsebeszeti Klin, Moricz Zsigmond Korut 22, 4032, Debrecen

DRC Kft.

3252, Ady Endre Utca 12/b, 8230, Balatonfured

University Of Szeged

3253: Csaladorvosi Intezet es Rendelo, Tisza Lajos Korut 109, 6725, Szeged

Semmelweis University

3251: Varosmajori Sziv es Ergyogy K, Varosmajor Utca 68, Kerulet, Budapest XII

Central Hospital Of Northern Pest Military Hospital

3259: Kardiologiai Szakrendelo, Robert Karoly Korut 44, 1134, Budapest XIII

Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet

3261: Szent Istvan Telephely I Belgy Osztaly, Nagyvarad Ter 1, 1097, Budapest Ix

Budapesti Uzsoki Utcai Korhaz

3260, Uzsoki Utca 29-41, 1145, Budapest XIV

Italy

16 sites · Ended

ASST Grande Ospedale Metropolitano Niguarda

3310:S.C. Cardiologia 2 - Insufficienza Cardiaca e Trapianti, Piazza Dell'ospedale Maggiore 3, 20162, Milan

Azienda Ospedaliera Policlinico Universitario Tor Vergata

3313:U.O.C. Cardiologia, Viale Oxford 81, 00133, Rome

I.N.R.C.A. Istituto Nazionale Di Riposo E Cura Per Gli Anziani

3305:UOC Clinica Medica e Geriatrica, Via Santa Margherita 5, 60124, Ancona

University Hospital Of Ferrara

3303:Centro Scompenso Cardiaco U.O. Cardiologia, Cona, Via Aldo Moro 8, Ferrara

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

3311:UOSD Scompenso Cardiaco, Largo Francesco Vito 1, 00168, Rome

Santa Maria Degli Angeli Hospital

3316:S.C. Cardiologia, Via Montereale 24, 33170, Pordenone

Azienda Sanitaria Universitaria Friuli Centrale

3315:S.O.C. Cardiologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine

Azienda Ospedaliera Dei Colli

3312:U.O.S.D. Scompenso Cardiaco e Cardiologia Riabilitativa, Via Leonardo Bianchi, 80131, Naples

Azienda Ospedaliera Papa Giovanni XXIII

3302:U.O.C. Cardiologia 1, Piazza Oms 1, 24127, Bergamo

Azienda Ospedaliero Universitaria Pisana

3307:U.O Medicina 1, Via Roma 67, 56126, Pisa

Azienda USL IRCCS Di Reggio Emilia

3308:U.O.C. Cardiologia Ospedaliera, Viale Risorgimento 80, 42123, Reggio Emilia

Cattinara Hospital

3306:Polo Cardiologico - S.C. Cardiologia, Strada Di Fiume 447, 34149, Trieste

Azienda Ospedale-Universita Padova

3309:U.O.C. Clinica Medica 3 Dipartimento di Medicina - DIMED, Via Nicolo' Giustiniani 2, 35128, Padova

Azienda Ospedaliera Universitaria Gaetano Martino Messina

3314:U.O.S. Diagnosi e Terapia dello Scompenso Cardiaco U.O.C. Medicina Interna, Via Consolare Valeria N 1, 98124, Messina

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

3301:U.O.C. Cardiologia, Piazzale Spedali Civili 1, 25123, Brescia

Centro Cardiologico Monzino S.p.A.

3304:U.O. Scompenso, Cardiologia Critica e Cardiologia Riabilitativa, Via Carlo Parea 4, 20138, Milan

Netherlands

6 sites · Ended

Stichting Radboud University Medical Center

#3352:Cardiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen

Zuyderland Medisch Centrum Stichting

#3356:Cardiology, Henri Dunantstraat 5, 6419 PC, Heerlen

Stichting Treant Ziekenhuiszorg

#3355:Cardiology, Boermarkeweg 60, 7824 AA, Emmen

Universitair Medisch Centrum Groningen

#3351:Cardiology, Hanzeplein 1, 9713 GZ, Groningen

Medisch Centrum Leeuwarden B.V.

#3354:Cardiology, Henri Dunantweg 2, 8934 AD, Leeuwarden

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

#3353:Cardiology, Dr. Molewaterplein 50, 3015 GE, Rotterdam

Portugal

4 sites · Ended

Hospital De Sao Francisco Xavier

3401: Serviço de Medicina Interna, Estrada Forte Do Alto Duque, 1449-005, Lisbon

Hospital Da Luz S.A.

3402: Serviço de Medicina Interna, Avenida Lusiada 100, 1500-650, Lisbon

Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.

3404: Serviço de Cardiologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia

Centro Hospitalar Universitario De Lisboa Norte E.P.E.

3403: Serviço de Cardiologia, Avenida Professor Egas Moniz, 1649-035, Lisbon

Slovakia

8 sites · Ended

InterStom s.r.o.

3456: Ambulancia vnútorného lekárstva, Cajkovskeho 2, Klokocina, Nitra

Interna SK s.r.o.

3459: Kardiologická ambulancia, Mudr. Pribulu 412/4, 089 01, Svidnik

Medical group Kosice s.r.o.

3452: Kardiologická ambulancia, Mudronova 29, Juh, Kosice

Medispol s.r.o.

3453: Ambulancia vnútorného lekárstva, Konstantinova 17, 080 01, Presov

Kardiomed Nz s.r.o.

3464: Kardiologická ambulancia, L. Stura 18, 940 02, Nove Zamky

KVC Kardiovaskularne Centrum s.r.o.

3463: Kardiologická ambulanci, Prieloztek 1, Jahodniky, Martin

Alian s.r.o.

3451: Angiologická ambulancia, Sv. Jakuba 33, 085 01, Bardejov

Kardiocentrum Nitra s.r.o.

3455: Kardiologická ambulancia, Spitalska 6, Stare Mesto, Nitra

Spain

14 sites · Ended

Hospital Universitario 12 De Octubre

3509: Cardiologia, Bloque D, Avenida De Cordoba Sn, Madrid

Hospital Universitario Ramon Y Cajal

3510: Medicina interna, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid

Hospital Alta Resolución De Utrera

3513: Cardiología, Avda Brigadas Internacionales,s/n Consulta de Cardiología. Bloque 3., 41410, UTRERA. Sevilla

Hospital Universitario Puerta De Hierro De Majadahonda

3507: Cardiologia, Calle De Manuel De Falla 1, 28222, Majadahonda

Hospital Clinico Universitario De Valencia

3502: Cardiologia, Avenida Blasco Ibanez 17, 46010, Valencia

Hospital Clinico San Carlos

3512: Cardiologia, Calle Del Profesor Martin Lagos Sn, 28040, Madrid

El Hospital Universitario De Gran Canaria Dr. Negrin

3503: Cardiologia, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria

University Clinical Hospital Virgen De La Arrixaca

3506: Cardiologia, Carretera De Cartagena Sn, El Palmar, Murcia

Hospital Universitario Virgen De La Victoria

3504: Cardiologia, Calle Del Arroyo Teatinos Sn, 29010, Malaga

Hospital Universitario Y Politecnico La Fe

3505: Cardiologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Hospital Universitario Virgen De Valme

3501: Medicina interna, Avenida Bellavista S/n, 41014, Sevilla

Marina Salud S.A.

3511: Cardiologia, Partida Beniadla S/n, 03700, Denia

Complexo Hospitalario Universitario De Santiago

3508: Cardiologia, Calle Choupana Da S/n, 15706, Santiago De Compostela

Hospital Universitario Juan Ramon Jimenez

3514: Cardiologia, Ronda Exterior Norte S/n, 21005, Huelva

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start	Recruitment end
Bulgaria	2024-03-27	2024-03-27	2024-11-08
Czechia	2024-08-07	2024-08-07	2024-08-09
France	2024-08-09	2024-08-09	2024-08-09
Germany	2024-05-23	2024-05-23	2024-08-09
Hungary	2024-07-31	2024-07-31	2024-08-09
Italy	2024-04-26	2024-04-26	2024-08-09
Portugal	2024-03-13	2024-03-13	2024-08-09
Slovakia	2024-05-09	2024-05-09	2024-08-09
Spain	2024-04-17	2024-04-17	2024-08-09

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 9 · Art. 38 CTR

Temporary halt TH-40665

Halt date: 2024-08-09
Member states concerned: Spain
Publication date: 2024-08-13
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Temporary halt TH-40667

Halt date: 2024-08-09
Member states concerned: Slovakia
Publication date: 2024-08-13
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Temporary halt TH-40657

Halt date: 2024-08-09
Member states concerned: France
Publication date: 2024-08-13
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Temporary halt TH-40669

Halt date: 2024-08-09
Member states concerned: Czechia
Publication date: 2024-08-13
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Temporary halt TH-40659

Halt date: 2024-08-09
Member states concerned: Germany
Publication date: 2024-08-13
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Temporary halt TH-56475

Halt date: 2024-11-08
Member states concerned: Bulgaria
Publication date: 2024-11-08
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Temporary halt TH-40671

Halt date: 2024-08-09
Member states concerned: Hungary
Publication date: 2024-08-13
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Temporary halt TH-40661

Halt date: 2024-08-09
Member states concerned: Italy
Publication date: 2024-08-13
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Temporary halt TH-40663

Halt date: 2024-08-09
Member states concerned: Portugal
Publication date: 2024-08-13
Reason: Safety related (clinical or pre-clinical results)
Follow-up measures: The decision was taken to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.
Benefit-risk balance changed: Yes
Treatment stopped: Yes

Urgent safety measures 1 · Art. 54 CTR

Urgent safety measure US-40578

Event date: 2024-08-09
Submission date: 2024-08-13
In response to: OTHER
Member states affected: Bulgaria, Denmark, France, Germany, Italy, Portugal, Spain, Netherlands, Slovakia, Czechia, Hungary
Event description: The Sponsor’s decision to trigger this urgent safety measure follows a recommendation of the the Data Monitoring Committee after reviewing of aggregate safety data from Study CXXB750A12201. More details are provided in the attached letter.
Measures taken: After consulting with the DMC and the study’s academic Executive Committee, the Sponsor took the decision to temporary halt screening, randomizing and dosing of all double-blind injectable medication of XXB750 and matching placebo in Study CXXB750A12201 until further notice.
All randomized participants actively involved in the study should continue to attend study visits as per the study schedule and undergo all study procedures, with careful monitoring of study participants. See the attached letter for more details.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Title	Submission date	Status	Type
2023-504678-39-00_CXXB750A12201_Summary of Results SUM-104297	2025-10-30T14:34:04	Submitted	Summary of Results
2023-504678-39-00_CXXB750A12201_Summary of Results SUM-124357	2026-03-20T09:54:11	Submitted	Summary of Results

Layperson summary Annex V

Title	Submission date	Status	Type
CXXB750A12201_PatientSummary_English-US	2025-10-30T15:34:59	Submitted	Laypersons Summary of Results
CXXB750A12201_PatientSummary	2026-02-27T13:03:02	Submitted	Laypersons Summary of Results

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_Chinese-Taiwan	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_English-US_28Oct2025	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_German	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_HaitianCreole-US	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_Hungarian	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_Italian	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_Japanese	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_Portuguese	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_Slovak	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_Spanish-Spain	1
Laypersons summary of results (for publication)	CXXB750A12201_PatientSummary_Spanish-US	1
Recruitment arrangements (for publication)	K1_Recruitment Arrangements - Country_1_BG_Bulgarian_NonRed	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangements - Country_1_ES_Spanish_NonRed	18Dec2023
Recruitment arrangements (for publication)	K2_Advertisements - Country_1_ES_Spanish_NonRed	v01
Recruitment arrangements (for publication)	K2_Advertisements - Country_2_ES_Spanish_NonRed	v01
Recruitment arrangements (for publication)	K2_Advertisements - Country_3_ES_Spanish_NonRed	v01
Subject information and informed consent form (for publication)	L1_ICF - Follow up for pregnant participant_1_BG_Bulgarian_NonRed	00.00.01
Subject information and informed consent form (for publication)	L1_ICF - Follow up for pregnant participant_1_BG_English_NonRed	00.00.01
Subject information and informed consent form (for publication)	L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed	v00.00.00
Subject information and informed consent form (for publication)	L1_ICF - Genetics_1_BG_Bulgarian_NonRed	00.00.02
Subject information and informed consent form (for publication)	L1_ICF - Genetics_1_BG_English_NonRed	00.00.02
Subject information and informed consent form (for publication)	L1_ICF - Genetics_1_ES_Spanish_NonRed	v00.00.00
Subject information and informed consent form (for publication)	L1_ICF - Main ICF - Adult_1_BG_Bulgarian_Red	00.00.02
Subject information and informed consent form (for publication)	L1_ICF - Main ICF - Adult_1_BG_English_Red	00.00.02
Subject information and informed consent form (for publication)	L1_ICF - Main ICF - Adult_1_ES_Spanish_NonRed	v00.00.01
Subject information and informed consent form (for publication)	L1_ICF - Separate Data Protection Consent_1_ES_Spanish_NonRed	v03
Subject information and informed consent form (for publication)	L1_ICF - Separate Data Protection Consent_2_ES_Spanish_NonRed	v03
Subject information and informed consent form (for publication)	L2_ICF Procedure_1_ES_Spanish_NonRed	5Oct2023
Summary of results (for publication)	2023-504678-39-00_CXXB750A12201_Summary of Results	1
Summary of results (for publication)	2023-504678-39-00_CXXB750A12201_Summary of Results_ updated	1

Application history

11 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-10-31	Italy	Acceptable 2024-03-04	2024-03-04
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2024-04-05	Italy	Acceptable 2024-03-04	2024-04-05
3	SUBSEQUENT ADDITION OF MSC	APP-3	2024-04-19			2024-06-13
4	SUBSEQUENT ADDITION OF MSC	APP-4	2024-04-19		Acceptable 2024-03-04	2024-07-10
5	SUBSTANTIAL MODIFICATION	SM-1	2024-04-26		Acceptable	2024-05-31
6	SUBSTANTIAL MODIFICATION	SM-3	2024-06-14		Acceptable	2024-07-03
7	SUBSTANTIAL MODIFICATION	SM-4	2024-06-14		Acceptable	2024-07-03
8	SUBSTANTIAL MODIFICATION	SM-5	2024-06-14		Acceptable	2024-07-17
9	NON SUBSTANTIAL MODIFICATION	NSM-2	2024-07-17			2024-07-17
10	NON SUBSTANTIAL MODIFICATION	NSM-3	2024-07-17			2024-07-17
11	NON SUBSTANTIAL MODIFICATION	NSM-4	2024-11-08			2024-11-08

A proof of concept and dose-finding study of XXB750 in patients with heart failure

Overview

Key facts

Trial design

Main objective

Secondary objectives 3

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 7

Exclusion criteria 6

Endpoints

Primary endpoints 1

Secondary endpoints 2

Investigational products

Test 1

Comparator 1

Placebo 1

Auxiliary 22

Sponsors and contacts

Novartis Pharma AG

Scientific contact point

Public contact point

Third parties 24

Locations

By country

Investigational sites

Country notifications

Oversight and notifications

Temporary halts 9 · Art. 38 CTR

Urgent safety measures 1 · Art. 54 CTR

Results and documents

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 30 files

Application history

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