Clinical trial • Phase IV • Cardiology

SOTATERCEPT for Pulmonary arterial hypertension

Phase IV trial of SOTATERCEPT for Pulmonary arterial hypertension. open-label. 145 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Pulmonary arterial hypertension
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
30-01-2025
First CTIS Authorization Date
26-05-2025

Trial design

open-label Phase IV trial in Czechia, Hungary, Spain and others.

Open Label
Yes
Target Sample Size
145

Eligibility

Recruits 145 No vulnerable populations selected. Participants are adults only; informed consent is obtained from participants. No assent for minors is described..

Vulnerable Population
No vulnerable populations selected. Participants are adults only; informed consent is obtained from participants. No assent for minors is described.

Inclusion criteria

  • {"criterion_text":"- Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION)"}
  • {"criterion_text":"- Has not started treatment with commercially available sotatercept"}

Exclusion criteria

  • {"criterion_text":"- Has prior exposure to luspatercept and/or is planning to begin treatment with luspatercept while enrolled in the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants with one or more adverse events (AEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants who discontinue study intervention due to an AE","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
145
Recruitment Window Months
28
Consent Approach
Informed consent is required from participants (adult population). Country-specific subject information and informed consent forms are available (documents listed for Czech Republic, Hungary, Spain, Poland, Netherlands, France, Italy and others). Optional/ancillary consent forms (e.g. pregnant partner, pregnancy follow-up) are provided where applicable. No assent procedures for minors are described.

Geography

Total Number Of Sites
28
Total Number Of Participants
67

Czechia

Earliest CTIS Part Ii Submission Date
07-05-2025
Latest Decision Or Authorization Date
30-05-2025
Processing Time Days
23
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
II. interní klinika kardiologie a angiologie VFN a 1.LF UK
Contact Person Name
Pavel Jansa
Contact Person Email
pavel.jansa@vfn.cz

Hungary

Earliest CTIS Part Ii Submission Date
14-05-2025
Latest Decision Or Authorization Date
29-05-2025
Processing Time Days
15
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
University Of Szeged
Department Name
Szent-Györgyi Albert Klinikai Központ, Családorvosi Intézet és Rendelő
Contact Person Name
Gergely Ágoston
Site Name
Gottsegen National Cardiovascular Center
Department Name
Felnőtt Kardiológiai Osztály
Contact Person Name
Hajnalka Balint
Contact Person Email
balint@gmail.com
Site Name
Clinic Of Pulmonology Semmelweis University
Department Name
Pulmonológiai Klinika
Contact Person Name
Kristóf Karlócai
Contact Person Email
kristof@karlocai.hu

Spain

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
28-05-2025
Processing Time Days
15
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Hospital Universitario De Toledo
Department Name
Neumology
Contact Person Name
María Lázaro Salvador
Contact Person Email
maria.lasal@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neumology
Contact Person Name
Luis Jara Palomares
Site Name
Hospital Clinic De Barcelona
Department Name
Neumology
Contact Person Name
Isabel Blanco Vich
Contact Person Email
iblanco2@clinic.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neumology
Contact Person Name
Pilar Escribano Subias
Site Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name
Neumology
Contact Person Name
Berta Saez Jimenez
Contact Person Email
berta.saez@vallhebron.cat
Site Name
Hospital Universitario La Paz
Department Name
Neumology
Contact Person Name
Clara Soto Abadanes
Contact Person Email
clarasoto27@gmail.com
Site Name
University Hospital Son Espases
Department Name
Neumology
Contact Person Name
Ernest Sala Llinas
Contact Person Email
ernest.sala@ssib.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neumology
Contact Person Name
José Cifrián Martínez
Contact Person Email
josemanuel.cifrian@scsalud.es

Poland

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
01-06-2025
Processing Time Days
23
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
Contact Person Name
Grzegorz Kopeć
Contact Person Email
g.kopec@szpitaljp2.krakow.pl

Netherlands

Earliest CTIS Part Ii Submission Date
08-05-2025
Latest Decision Or Authorization Date
26-05-2025
Processing Time Days
18
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Cardiology
Contact Person Name
Marco Post
Contact Person Email
m.post@antoniusziekenhuis.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Cardiology
Contact Person Name
Toon Duijnhouwer
Contact Person Email
onderzoek.cardio@radboudumc.nl

France

Earliest CTIS Part Ii Submission Date
17-03-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
105
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires
Contact Person Name
Elise Artaud-Macari
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Cardiologie
Contact Person Name
Francois Picard
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service de Pneumologie
Contact Person Name
Martine Reynaud-Gaubert
Contact Person Email
martine.reynaud@ap-hm.fr
Site Name
CHU Gabriel-Montpied
Department Name
Cardiologie médicale et médecine vasculaire
Contact Person Name
Romain Tresorier

Italy

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
30-05-2025
Processing Time Days
24
Number Of Sites
9
Number Of Participants
22

Sites

Site Name
Azienda Ospedaliero Universitaria Di Sassari
Department Name
Sc Cardiologia Clinica e Interventistica
Contact Person Name
Gavino Casu
Contact Person Email
gavino.casu@aouss.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Malattie Cardiovascolari
Contact Person Name
Roberto Badagliacca
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Dipartimento Cardiotoracovascolare
Contact Person Name
Andrea Garascia
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
S.C. Cardiologia
Contact Person Name
Laura Scelsi
Contact Person Email
l.scelsi@smatteo.pv.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
U.O.C. Pneumologia
Contact Person Name
Giuseppe Paciocco
Contact Person Email
giuseppe.paciocco@unimib.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
U.O.C. Cardiologia
Contact Person Name
Daniele Prati
Contact Person Email
daniele.prati@aovr.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
U.O.C. Cardiologia
Contact Person Name
Fabio Dardi
Contact Person Email
fabio_dardi@yahoo.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
DICATOV Dipartimento CardioToracoVascolare
Contact Person Name
Pietro Ameri
Contact Person Email
pietro.ameri@unige.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dipartimento cardio-toraco-vascolare
Contact Person Name
Alessandro Santaniello

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Imperial Clinical Research Services International Ltd.
Responsibilities
Retention Materials
Name
Parexel International Corp.
Responsibilities
EUB Call center and medical escalation service
Name
PPD International Holdings LLC

Third parties

  • {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Retention Materials","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB Call center and medical escalation service","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Travel & Reimbursment","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Sotatercept (MK-7962)
Active Substance
SOTATERCEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Mixed: product records include both prodAuthStatus=1 (authorised formulations) and prodAuthStatus=2 (investigational/unlicensed formulations)
Orphan Designation
Yes
Maximum Dose
90 mg
Combination Treatment
Yes

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