Clinical trial • Phase III • Immunology|Rare Disease

BELUMOSUDIL MESILATE for Chronic graft versus host disease

Phase III trial of BELUMOSUDIL MESILATE for Chronic graft versus host disease.

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Chronic graft versus host disease
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
05-10-2023
First CTIS Authorization Date
12-02-2024

Trial design

Randomised, belumosudil in combination with corticosteroids versus placebo in combination with corticosteroids (comparator described as placebo + corticosteroids); no specific belumosudil dose/schedule stated in the ctis record for the randomized comparison-controlled Phase III trial across 70 sites in Denmark, Portugal, Germany and others.

Randomised
Yes
Comparator
Belumosudil in combination with corticosteroids versus placebo in combination with corticosteroids (comparator described as placebo + corticosteroids); no specific belumosudil dose/schedule stated in the CTIS record for the randomized comparison
Target Sample Size
193

Eligibility

Recruits 193 paediatric patients.

Pregnancy Exclusion
Female participants who are pregnant or breastfeeding
Vulnerable Population
The study includes adolescents (minimum age 12 years). Consent requirements state: 'Participants or their legally authorized representative must be capable of giving signed informed consent.' Age-specific information and consent/assent documents are provided (e.g. L1-sis-icf-children, L1-sis-icf-parents, adolescent/assent forms) in multiple language versions.

Inclusion criteria

  • {"criterion_text":"- Patients must be at least 12 years of age inclusive, at the time of signing the informed consent\n- Participants who have undergone allogenic HCT with newly diagnosed moderate to severe cGVHD according to NIH consensus diagnosis and staging criteria (2014)\n- Participants who require systemic treatment with corticosteroids for cGVHD\n- Participants who have not received any prior systemic treatment for cGVHD (including ECP)\n- If participants are receiving other immunosuppressive agents for the prophylaxis or treatment of acute GVHD, the dose should be under the threshold pre-defined in protocol\n- For adult participants, the body weight should be ≥40 kg. For adolescent participants, the body weight should be ≥30 kg.\n- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- Participants or their legally authorized representative must be capable of giving signed informed consent"}

Exclusion criteria

  • {"criterion_text":"- Active uncontrolled cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection worsening are present according to Investigator’s judgement\n- Received any investigational agents, or any investigational device or procedure, or prohibited therapy for this study within 28 days or 5 elimination half-lives prior to randomization, whichever is longer\n- -\tAbsolute neutrophil count (ANC) <0.5 x 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed to reach this level during screening\n- Karnofsky (if aged ≥16 years)/Lansky (if aged <16 years) Performance Score of < 60\n- -\tPlatelets <25 x 109/L. Platelet transfusion is not allowed within 3 days before the screening hematological test\n- Any active, uncontrolled infections assessed to be clinically significant by the Investigator\n- Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged <18 years)\n- -\tAspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN without liver cGVHD or>5 × ULN with liver) cGVHD\n- Total bilirubin >1.5 × (ULN) (>3 × ULN if Gilbert syndrome)\n- Participant has forced expiratory volume in 1 second (FEV1) of predicted ≤39% or has lung score of 3 according to NIH consensus diagnostic and staging criteria (2014)\n- History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease or coronary artery disease)\n- Diagnosed or treated for another malignancy other than the underlying disease allogeneic HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy\n- Known history of human immunodeficiency virus (HIV)\n- Active viral disease including hepatitis B virus (HBV) or hepatitis C virus (HCV)\n- -\tAny evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease after the most recent allogeneic HCT\n- Post-transplant lymphoproliferative disease within 4 weeks prior to randomization\n- Unable to swallow tablets\n- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures\n- Female participants who are pregnant or breastfeeding\n- Unable to tolerate a prednisone equivalent dose of corticosteroids ≥ 1 mg/kg/day\n- Participant has had previous exposure to belumosudil.\n- Received any previous systemic treatment for cGVHD with the following exception: Corticosteroids for cGVHD received within 7 days prior to the planned administration of IMP only if in the interest of participant."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Event-Free Survival (EFS) from the date of randomization to the date of any predefined event, whichever occurs first","definition_or_measurement_approach":"EFS measured from date of randomization to the date of any predefined event (whichever occurs first) as stated in the protocol."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants who achieve a clinically relevant reduction in mLSS of at least 6 points from baseline (Only in participants at least 18 years of age)","definition_or_measurement_approach":"Measured as proportion achieving ≥6-point reduction in modified Lee Symptom Scale (mLSS) from baseline; applicable only to participants ≥18 years."}
  • {"endpoint_text":"- Demonstrate the superiority of belumosudil in combination with prednisone vs prednisone alone in durable overall response rate (ORR)","definition_or_measurement_approach":"Overall response rate (ORR) per 2014 NIH consensus response criteria; durability defined in protocol (e.g., maintained for at least 6 months as specified in other endpoints)."}
  • {"endpoint_text":"- Demonstrate the superiority of belumosudil in combination with prednisone vs prednisone alone in the rate of corticosteroid withdrawal","definition_or_measurement_approach":"Proportion of participants who successfully discontinue all systemic corticosteroids for cGVHD for at least 30 days before cGVHD progression, start of new systemic treatment for cGVHD, relapse/recurrence of underlying disease, or unacceptable toxicity."}
  • {"endpoint_text":"- Overall response rate (ORR)","definition_or_measurement_approach":"ORR determined according to 2014 NIH consensus response criteria (PR or CR)."}
  • {"endpoint_text":"- ORR by 24 weeks","definition_or_measurement_approach":"Proportion achieving ORR within 24 weeks."}
  • {"endpoint_text":"- Duration of response (DOR)","definition_or_measurement_approach":"Time from date of first response to date of cGVHD progression, start of new systemic treatment for cGVHD, or death, whichever occurs first; determined only for participants who achieved overall response (PR or CR) per 2014 NIH criteria."}
  • {"endpoint_text":"- Dose reduction in corticosteroids","definition_or_measurement_approach":"Proportion or extent of reduction in daily corticosteroid dose (as defined in protocol)."}
  • {"endpoint_text":"- Failure Free Survival (FFS)","definition_or_measurement_approach":"FFS defined as time from randomization to start of a new systemic treatment for cGVHD, relapse/recurrence of underlying disease, or death, whichever occurs first."}
  • {"endpoint_text":"- Change in patient reported outcome (PRO)","definition_or_measurement_approach":"Change from baseline in PROMIS-GH (only participants ≥18 years) and EQ-5D-5L as specified in protocol."}
  • {"endpoint_text":"- Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)","definition_or_measurement_approach":"Counts and summaries of TEAEs, serious TEAEs and AESIs per safety reporting procedures."}
  • {"endpoint_text":"- The time from the date of randomization to the date of death due to any cause","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause."}
  • {"endpoint_text":"- Time to Response is defined as the time from randomization to the date the patient has first response (CR or PR).","definition_or_measurement_approach":"Measured as time from randomization to first documented CR or PR per 2014 NIH criteria."}
  • {"endpoint_text":"- Proportion of participants who achieve CR or PR as per NIH consensus response criteria (2014) at any time point in each involved organ and before the start of a new systemic therapy for cGVHD.","definition_or_measurement_approach":"Organ-specific response rates per 2014 NIH consensus response criteria, assessed prior to initiation of new systemic therapy for cGVHD."}

Recruitment

Planned Sample Size
193
Recruitment Window Months
40
Consent Approach
Informed consent must be signed by the participant or their legally authorized representative ('Participants or their legally authorized representative must be capable of giving signed informed consent'). Age-specific information and consent/assent materials are provided (e.g. L1-sis-icf-children, L1-sis-icf-parents, adolescent/assent forms) and multiple language versions of ICFs are included in the documents list.

Methods

  • K1 recruitment arrangements and K2 recruitment materials are provided (leaflets/infographics, doctor-to-doctor referral letters); materials available in multiple languages per country-specific documentation (documents titled K1-recruitment-arrangements and K2-recruitment-material-... in the document list).

Geography

Total Number Of Sites
70
Total Number Of Participants
157

Denmark

Latest Decision Or Authorization Date
12-02-2024
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Aarhus Universitetshospital
Department Name
Oncology
Contact Person Name
Gitte Olesen
Contact Person Email
gitolese@rm.dk
Site Name
Odense University Hospital
Department Name
Oncology
Contact Person Name
Duruta Weber
Contact Person Email
Duruta.Weber@rsyd.dk
Site Name
Rigshospitalet
Department Name
Oncology
Contact Person Name
Brian Kornblit

Portugal

Latest Decision Or Authorization Date
04-06-2024
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Hospital De Santa Maria E.P.E.
Department Name
Centro Hospitalar Universitario Lisboa Norte- Hospital Santa Maria (#1)
Contact Person Name
Joao Forjaz De Lacerda
Contact Person Email
jlacerda@medicina.ulisboa.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
INSTITUITO PORTUGUES DE ONCOLOGIA DO PORTO CLIN. ONCOL. IV( #22)
Contact Person Name
Gil Paiva Brás

Germany

Latest Decision Or Authorization Date
13-02-2024
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Charite-Campus Virchow-Klinikum - Universitatsmedizin Berlin / Klinik fur Padiatrie
Contact Person Name
Olaf Penack
Contact Person Email
olaf.penack@charite.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Hamatologie, Onkologie, Immunologie, Rheumatologie und Pulmonologie
Contact Person Name
Wolfgang Bethge
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Medizinische Klinik und Poliklinik A Hamatologie, Hamostaseologie, Onkologie, Pneumologie
Contact Person Name
Matthias Stelljes
Site Name
Medical Center - University Of Freiburg
Department Name
Cardiology
Contact Person Name
Robert Zeiser
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik und Poliklinik I Hamatologie, Zelltherapie und Medizinische Onkologie
Contact Person Name
Katharina Egger-Heidrich
Contact Person Email
Katharina.Heidrich@ukdd.de
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Klinik für Innere Medizin II / Sektion für Stammzelltransplatation und zelluläre Immuntherapie
Contact Person Name
Friedrich Stölzel
Contact Person Email
friedrich.stoelzel@uksh.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Innere Medizin III: Hamatologie/Onkologie
Contact Person Name
Daniel Wolff
Contact Person Email
daniel.wolff@ukr.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik I - Innere Medizin
Contact Person Name
Udo Holtick
Contact Person Email
udo.holtick@uk-koeln.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation
Contact Person Name
Silke Heidenreich
Contact Person Email
s.heidenreich@uke.de

Czechia

Latest Decision Or Authorization Date
13-02-2024
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interni hematologicka klinika
Contact Person Name
Pavel Zak
Contact Person Email
pavel.zak@fnhk.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Contact Person Name
Zdenek Koristek
Contact Person Email
zdenek.koristek@fno.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Contact Person Name
Jiří Mayer
Contact Person Email
mayer.jiri@fnbrno.cz
Site Name
Institute Of Hematology And Blood Transfusion
Department Name
Ustav hematologie a krevni transfuze (#1)
Contact Person Name
Veronika Valkova
Contact Person Email
veronika.valkova@uhkt.cz

Austria

Latest Decision Or Authorization Date
19-02-2024
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Interne 1 - Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie
Contact Person Name
Johannes Clausen
Site Name
St. Anna Kinderspital GmbH
Department Name
Zentrum für Kinder- und Jugendheilkunde, Stammzelltransplantations-Station (1A)
Contact Person Name
Anita Lawitschka
Contact Person Email
anita.lawitschka@stanna.at
Site Name
Medical University Of Graz
Department Name
Klinische Abteilung fur Hamatologie
Contact Person Name
Bianca Huber-Kraßnitzer

Sweden

Latest Decision Or Authorization Date
16-02-2024
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Hematology
Contact Person Name
Beata Tomaszewska-Toporska
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
Department of Hematology
Contact Person Name
Krista Vaht
Contact Person Email
krista.vaht@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Karolinska Comprehensive Cancer Center
Contact Person Name
Johan Torlen

France

Latest Decision Or Authorization Date
07-06-2024
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'Hematologie
Contact Person Name
Patrice Chevallier
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hematologie clinique et Therapie cellulaire
Contact Person Name
Edouard Forcade
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département d'Hématologie Clinique et de Thérapie Cellulaire
Contact Person Name
Florent Malard
Contact Person Email
florent.malard@inserm.fr
Site Name
Hospices Civils De Lyon
Department Name
Service Hematologie Clinique
Contact Person Name
Helene Labussiere Wallet
Site Name
CHRU De Nancy
Department Name
Département d'hématologie
Contact Person Name
Maud Daveni-Piney
Contact Person Email
m.daveni-piney@chru-nancy.fr
Site Name
Assistance Publique Hopitaux De Paris (Claude Vellefaux)
Department Name
Service hematologie
Contact Person Name
David Michonneau
Contact Person Email
david.michonneau@aphp.fr
Site Name
Institut Paoli-Calmettes
Department Name
Departement Hematologie
Contact Person Name
Raynier Devillier
Contact Person Email
DEVILLIERR@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service Hematologie
Contact Person Name
Jean-Baptiste Mear

Belgium

Latest Decision Or Authorization Date
13-02-2024
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology
Contact Person Name
Dries Deeren
Contact Person Email
Dries.Deeren@azdelta.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Contact Person Name
Alexander Schauwvlieghe
Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Contact Person Name
Anke Delie
Contact Person Email
anke.delie@uzgent.be
Site Name
CHU De Liege
Department Name
Hematology
Contact Person Name
Evelyne Willems
Contact Person Email
ewillems@chuliege.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology
Contact Person Name
Xavier Poire
Site Name
UZ Leuven
Department Name
Hematology
Contact Person Name
Helene Schoemans
Contact Person Email
helene.schoemans@uzleuven.be

Italy

Latest Decision Or Authorization Date
15-02-2024
Number Of Sites
12
Number Of Participants
27

Sites

Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
Onco-ematologico e radioterapico
Contact Person Name
Massimo Martino
Contact Person Email
massimo.martino@ospedalerc.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
U.O. Clinica Ematologica
Contact Person Name
Anna Maria Raiola
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Ematologia
Contact Person Name
Francesca Patriarca
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Ematologia
Contact Person Name
Antonio Pierini
Contact Person Email
antonio.pierini@unipg.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Ematologia
Contact Person Name
Francesca Bonifazi
Contact Person Email
francesca.bonifazi@unibo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia
Contact Person Name
Maria Teresa Lupo Stanghellini
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Clinica Ematologica
Contact Person Name
Giorgia Mancini
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Ematologia e Trapianto di cellule staminali emopoietiche
Contact Person Name
Simona Sica
Contact Person Email
simona.sica@unicatt.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Ematologia I
Contact Person Name
Nicola Polverelli
Contact Person Email
n.polverelli@smatteo.pv.it
Site Name
Humanitas Research Hospital
Department Name
Ematologia
Contact Person Name
Stefania Bramanti
Site Name
Azienda Ospedaliera Papa Giovanni XXIII
Department Name
Oncologia
Contact Person Name
Alessandro Rambaldi
Contact Person Email
arambaldi@asst-pg23.it
Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
Ematologia
Contact Person Name
Benedetto Bruno
Contact Person Email
benedetto.bruno@unito.it

Spain

Latest Decision Or Authorization Date
13-02-2024
Number Of Sites
10
Number Of Participants
27

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Servicio de Hematología
Contact Person Name
Jaime Sanz
Contact Person Email
jaime.sanz@uv.es
Site Name
Institut Catala D'oncologia
Department Name
Servicio de Hematología
Contact Person Name
Alberto Mussetti
Contact Person Email
amussetti@iconcologia.net
Site Name
Hospital Universitario De Salamanca
Department Name
Servicio de Hematología
Contact Person Name
Lucia Lopez Corral
Contact Person Email
lucialopezcorral@usal.es
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Servicio de Hematología
Contact Person Name
Marta Gonzalez-Vicent
Contact Person Email
martagonzalezvicent@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Hematología
Contact Person Name
Carmen Martinez Muñoz
Contact Person Email
cmarti@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology Service
Contact Person Name
Maria Aranzazu Bermudez Rodriguez
Contact Person Email
maranzazu.bermudez@scsalud.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Hematología
Contact Person Name
Jose Antonio Perez Simon
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Hematología
Contact Person Name
Maria Jesus Pascual
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology Service
Contact Person Name
Carlos Solano Vercet
Contact Person Email
carlos.solano@uv.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio Hematología
Contact Person Name
Mi Kwon
Contact Person Email
m.kwon@salud.madrid.org

Greece

Latest Decision Or Authorization Date
16-02-2024
Number Of Sites
1
Number Of Participants
7

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department -BMT Unit
Contact Person Name
Ioanna Sakellari
Contact Person Email
ioannamarilena@gmail.com

Poland

Latest Decision Or Authorization Date
16-02-2024
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Transplantacji Szpiku i Onkohematologii
Contact Person Name
Sebastian Giebel
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Contact Person Name
Agnieszka Piekarska
Contact Person Email
babajaga@gumed.edu.pl
Site Name
Uniwersytecki Szpital Dzieciecy W Krakowie
Department Name
Osrodek Transplantacji, Uniwersytecki Szpital Dzieciecy( #1)
Contact Person Name
Jolanta Gozdzik
Contact Person Email
jgozdzik@cm-uj.krakow.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Im.Adrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
Department Name
Oddzial Hematologii i Transplantacji Szpiku
Contact Person Name
Anna Koclega
Contact Person Email
ohits@spskm.katowice.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
Department Name
Klinika Hematologii z Oddzialem Transplantacji Szpiku
Contact Person Name
Boguslaw Machalinski

Netherlands

Latest Decision Or Authorization Date
19-02-2024
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Afdeling Hematologie
Contact Person Name
Goda Choi
Contact Person Email
c.w.choi@umcg.nl
Site Name
Amsterdam UMC
Department Name
Department of Hematology
Contact Person Name
Man Wai Tang
Contact Person Email
m.w.tang@amsterdamumc.nl
Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Afdeling hematologie
Contact Person Name
Caroline Lindemans
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Afdeling hematologie
Contact Person Name
Annoek BROERS
Contact Person Email
a.broers@erasmusmc.nl

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Research & Development
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Endpoint Clinical Inc.
Responsibilities
sponsorDuties codes: ["3"]
Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties codes: ["7"]
Name
ESMS Global Limited
Responsibilities
Centralized 24-Hour Emergency System: eSMS (sponsorDuties code: 15)
Name
Precision for Medicine GmbH
Responsibilities
sponsorDuties codes: ["4"]
Name
Labcorp Central Laboratory Services LP
Responsibilities
sponsorDuties codes: ["4"]
Name
Labcorp Early Development Laboratories Inc.
Responsibilities
sponsorDuties codes: ["4"]

Third parties

  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [\"7\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties codes: [\"14\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties codes: [\"14\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties codes: [\"14\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A. (Warsaw address)","duties_or_roles":"sponsorDuties codes: [\"14\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Peifasyn Pharmaceutical Coop Of Piraeus Ltd.","duties_or_roles":"sponsorDuties codes: [\"14\"]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
SAR445761 - belumosudil
Active Substance
BELUMOSUDIL MESILATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 1
Orphan Designation
Yes
Maximum Dose
400 mg per day (maxDailyDoseAmount: 400 mg)
Investigational Product Name
same excipients except no hypromellose (placebo)
Modality
Other
Investigational Product Name
PREDNISONE / PREDNISOLONE (auxiliary corticosteroid)
Active Substance
PREDNISOLONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2 (listed as auxiliary medicinal product)
Maximum Dose
1 mg/kg per day (maxDailyDoseAmount: 1; doseUom mg/Kg)
Combination Treatment
Yes

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