Clinical trial • Phase III • Immunology|Rare Disease

RILZABRUTINIB for Immune thrombocytopenia (ITP)|Autoimmune thrombocytopenia|Primary immune thrombocytopenia

Phase III trial of RILZABRUTINIB for Immune thrombocytopenia (ITP)|Autoimmune thrombocytopenia|Primary immune thrombocytopenia. open-label.

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Immune thrombocytopenia (ITP)|Autoimmune thrombocytopenia|Primary immune thrombocytopenia
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
13-06-2025
First CTIS Authorization Date
07-10-2025

Trial design

open-label Phase III trial in France, Spain, Hungary and others.

Open Label
Yes
Target Sample Size
41

Eligibility

Recruits 41 Participants must be capable of giving signed informed consent as described in Appendix 1 Section 10.1 of the protocol; this includes compliance with requirements listed in the ICF and protocol. In countries where the legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative (Appendix 1 Section 10.1.3). The trial excludes individuals institutionalized by legal order or prisoners (E 27) and employees or immediate family of study site staff (E 29)..

Pregnancy Exclusion
E 26. Participant during pregnancy or nursing.
Vulnerable Population
Participants must be capable of giving signed informed consent as described in Appendix 1 Section 10.1 of the protocol; this includes compliance with requirements listed in the ICF and protocol. In countries where the legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative (Appendix 1 Section 10.1.3). The trial excludes individuals institutionalized by legal order or prisoners (E 27) and employees or immediate family of study site staff (E 29).

Inclusion criteria

  • {"criterion_text":"- I 01. Participant must be 18 or above years of age inclusive, at the time of signing the informed consent.\n- I 10. Capable of giving signed informed consent as described in Appendix 1 Section 10.1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative (Appendix 1 Section 10.1.3).\n- I 02. Male and female participants with a documented diagnosis of primary ITP in the medical history.\n- I 03. Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.\n- I 04. Participant received at least one course of first-line therapy per international guidelines or local standard of care (eg, oral or parenteral CS, IVIg, anti-D). Note: Participants may have received multiple courses of first-line therapy, either sequentially or in combination.\n- I 05. History of platelet response while on-treatment with first-line therapy.\n- I 06. Participant has loss of response, relapse, or steroid dependency.\n- I 07. Please see study protocol.\n- I 08. All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- I 09. Adequate hematologic, hepatic, and renal function (hemoglobin >9 g/dL within 1 week prior to Study Day 1), absolute neutrophil count ≥1500/μL,, AST and ALT ≤1.5×upper limit of normal (ULN), albumin ≥3 g/dL, total bilirubin ≤1.5×ULN (unless the participant has documented Gilbert syndrome), estimated glomerular filtration rate (GFR) >50mL/min/1.73m² (CKD-EPI 2021 Creatinine Equation [Race-Free]), International normalized ratio (INR) and activated partial thromboplastin time (APTT) values are within 20% of the normal ranges."}

Exclusion criteria

  • {"criterion_text":"- E 01. Participants with diagnosis of secondary ITP.\n- E 18. Participant received subsequent/advanced treatment for the treatment of ITP or was splenectomized before Study Day 1\n- E 19. Participant received drugs known to potentially improve thrombocytopenia to treat other conditions within 5 times the elimination half-life of the drug or within 14 days of Study Day 1, whichever is longer, or the participant is planned to receive treatment with drugs known to potentially improve thrombocytopenia for any indication during the course of the study.\n- E 10. HIV infection.\n- E 20. Please see study protocol.\n- E 21. Please see study protocol.\n- E 22. Please see study protocol.\n- E 23. Please see study protocol.\n- E 24. Please see study protocol.\n- E 25. Received any investigational drug within 6 months or 5 half-lives, whichever is longer, or is participating in another clinical trial.\n- E 26. Participant during pregnancy or nursing.\n- E 02. Participants with a diagnosis of Evans syndrome.\n- E 27. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n- E 28. 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- E 11. A history of active or latent tuberculosis (TB) (unless the participant has completed a full course of anti-tuberculosis therapy or it is documented by a specialist that the participant has been adequately treated and can begin treatment with an immunosuppressive agent). A positive test for TB (QuantiFERON-TB-Gold [QFT] or equivalent) performed at the screening visit or within the 3 months prior to screening.\n- E 29. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the International Council for Harmonization Good Clinical Practice [GCP] Ordinance E6).\n- E 30. Sensitivity to any of the study intervention, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.\n- E 12. Participants with uncontrolled or active HBV infection: Participants with positive HBsAg and/or HBV DNA.\n- E 13. Participants with active HCV infection: positive HCV-RNA and positive anti-HCV.\n- E 14. Current drug or alcohol abuse.\n- E 15. Refractory nausea and vomiting, malabsorption, external biliary shunt, significant bowel resection, or any other condition that would preclude adequate study drug absorption.\n- E 16. Participants who have undergone major surgery within 28 days prior to Study Day 1 or have planned surgery in the time frame of the study.\n- E 03. Participants with history of myelodysplastic syndrome\n- E 17. Please see study protocol.\n- E 04. Participant with history of or current life-threatening bleeding (eg., a bleed that results in hemodynamic instability or respiratory compromise) due to ITP.\n- E 05. Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.\n- E 06. Participants with history of solid organ transplant.\n- E 07. Participants with history of coagulation or bleeding disorders, including genetic conditions, other than ITP.\n- E 08. Please see the study protocol.\n- E 09. Positive COVID-19 molecular test (if COVID-19 testing required per local guidelines to be determined for each site)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The main study endpoint is to check the durable platelet response ie, to see how many participants can keep their platelet count at a safe level.","definition_or_measurement_approach":"The durable platelet response is the percentage of participants who can maintain a platelet count of at least 50,000 /μL (or between 30,000/μL and 50,000/μL and at least double their starting count) for at least half of their scheduled platelet checks every 2 weeks and for at least 4 valid visits in the last 12 weeks of the study, without needing rescue treatment."}
  • {"endpoint_text":"- The durable platelet response is the percentage of participants who can maintain a platelet count of at least 50,000 /μL (or between 30,000/μL and 50,000/μL and at least double their starting count) for at least half of their scheduled platelet checks every 2 weeks and for at least 4 valid visits in the last 12 weeks of the study, without needing rescue treatment.","definition_or_measurement_approach":"Durable platelet response defined as above: percentage of participants meeting the platelet count criteria (≥50,000/μL or 30,000–50,000/μL with ≥2× baseline) for at least half of scheduled biweekly platelet checks and at least 4 valid visits in the last 12 study weeks, without rescue treatment."}

Secondary endpoints

  • {"endpoint_text":"- 1.\tOverall platelet response: The percentage of participants who can achieve 2 platelet counts, at least 5 days apart, of at least 50,000/μL (or between 30,000/μL and 50,000/μL but at least double their starting count) without needing rescue treatment in the 4 weeks before the first high platelet count.","definition_or_measurement_approach":"Percentage of participants achieving two platelet counts ≥50,000/μL (or 30,000–50,000/μL with ≥2× baseline) at least 5 days apart, without rescue treatment in the 4 weeks prior to first high count."}
  • {"endpoint_text":"- 2.\tDuration of platelet response: The total number and proportion of weeks where participants maintain platelet counts of at least 50,000/μL (or between 30,000/μL and 50,000/μL but at least double their starting count) without needing rescue treatment in the 4 weeks before the high platelet count in participants who achieve a response.","definition_or_measurement_approach":"Total number and proportion of weeks with platelet counts meeting response criteria (≥50,000/μL or 30,000–50,000/μL with ≥2× baseline) without rescue treatment in the 4 weeks before the high count, among responders."}
  • {"endpoint_text":"- 3.\tBleeding: The change in immune thrombocytopenia bleeding scale score from the start of the study to the end of Week 28.","definition_or_measurement_approach":"Change from baseline to end of Week 28 in the immune thrombocytopenia bleeding scale (IBLS) score."}
  • {"endpoint_text":"- 4.\tCorticosteroid-sparing effect: The percentage of participants who can stop or reduce their corticosteroid dose by at least 50% or to less than 5 mg/day (prednisone equivalent) from the start of the study by the end of Week 28","definition_or_measurement_approach":"Percentage of participants who discontinue or reduce corticosteroid dose by ≥50% or to <5 mg/day prednisone-equivalent from baseline to Week 28."}

Recruitment

Planned Sample Size
41
Recruitment Window Months
36
Consent Approach
Participants must provide signed informed consent as described in Appendix 1 Section 10.1 of the protocol. The ICF includes compliance requirements and restrictions; in countries where the legal age of majority is above 18 years a specific ICF must also be signed by the participant’s legally authorized representative (Appendix 1 Section 10.1.3). Subject information and ICF documents are provided (multiple L1/L2 ICF documents and language-specific versions are present in the dossier, including English, Spanish, French, Polish, Italian, Czech, German, Hungarian).

Geography

Total Number Of Sites
42
Total Number Of Participants
41

France

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
21
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Médecine interne
Principal Investigator Name
Marc MICHEL
Principal Investigator Email
marc.michel2@aphp.fr
Contact Person Name
Marc MICHEL
Contact Person Email
marc.michel2@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medecine interne et maladies infectieuses
Principal Investigator Name
Jean-Francois VIALLARD
Principal Investigator Email
Jean-francois.viallard@chu-bordeaux.fr
Contact Person Name
Jean-Francois VIALLARD
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Médecine interne et immunologie clinique
Principal Investigator Name
Sylvain AUDIA
Principal Investigator Email
Sylvain.audia@chu-dijon.fr
Contact Person Name
Sylvain AUDIA
Contact Person Email
Sylvain.audia@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Médecine interne
Principal Investigator Name
Guillaume MOULIS
Principal Investigator Email
moulis.g@chu-toulouse.fr
Contact Person Name
Guillaume MOULIS
Contact Person Email
moulis.g@chu-toulouse.fr

Spain

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
09-10-2025
Processing Time Days
17
Number Of Sites
9
Number Of Participants
11

Sites

Site Name
Hospital Universitario De Canarias
Department Name
Hematology
Principal Investigator Name
Sunil Lakhwani
Principal Investigator Email
sunillakhwani@hotmail.com
Contact Person Name
Sunil Lakhwani
Contact Person Email
sunillakhwani@hotmail.com
Site Name
Hospital Universitario La Paz
Department Name
Hematology
Principal Investigator Name
Maria Teresa Alvarez Roman
Principal Investigator Email
talvarez.ensayos@gmail.com
Contact Person Name
Maria Teresa Alvarez Roman
Contact Person Email
talvarez.ensayos@gmail.com
Site Name
Hospital Del Mar
Department Name
Hematology
Principal Investigator Name
Blanca Sanchez Gonzalez
Principal Investigator Email
97894@hospitaldelmar.cat
Contact Person Name
Blanca Sanchez Gonzalez
Contact Person Email
97894@hospitaldelmar.cat
Site Name
Hospital General Universitario Morales Meseguer
Department Name
Hematology
Principal Investigator Name
Maria Luisa Lozano Almela
Principal Investigator Email
mllozano@um.es
Contact Person Name
Maria Luisa Lozano Almela
Contact Person Email
mllozano@um.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Maria Eva Mingot Castellano
Principal Investigator Email
mariae.mingot.sspa@juntadeandalucia.es
Contact Person Name
Maria Eva Mingot Castellano
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Principal Investigator Name
Cristina Pascual Izquierdo
Principal Investigator Email
cpascuali@salud.madrid.org
Contact Person Name
Cristina Pascual Izquierdo
Contact Person Email
cpascuali@salud.madrid.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
David Valcarcel Ferreiras
Principal Investigator Email
dvalcarcel@vhio.net
Contact Person Name
David Valcarcel Ferreiras
Contact Person Email
dvalcarcel@vhio.net
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Jose Ramon Gonzalez Porras
Principal Investigator Email
jrgp@usal.es
Contact Person Name
Jose Ramon Gonzalez Porras
Contact Person Email
jrgp@usal.es
Site Name
Hospital Universitario De Burgos
Department Name
Hematology
Principal Investigator Name
Tomas Jose Gonzalez Lopez
Principal Investigator Email
tjgonzalez@saludcastillayleon.es
Contact Person Name
Tomas Jose Gonzalez Lopez

Hungary

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
232
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
University Of Debrecen
Department Name
Haematology
Principal Investigator Name
Árpád Illés
Principal Investigator Email
illes.arpad@med.unideb.hu
Contact Person Name
Árpád Illés
Contact Person Email
illes.arpad@med.unideb.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Haematology
Principal Investigator Name
Peter Rajnics
Principal Investigator Email
rajnicsp@hotmail.com
Contact Person Name
Peter Rajnics
Contact Person Email
rajnicsp@hotmail.com
Site Name
Semmelweis University
Department Name
Department of Internal Medicine and Haematology
Principal Investigator Name
Zsolt Gyorgy Nagy
Principal Investigator Email
nagy.zsolt@med.semmelweis-univ.hu
Contact Person Name
Zsolt Gyorgy Nagy

Italy

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
256
Number Of Sites
10
Number Of Participants
8

Sites

Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
UOC Ematologia
Principal Investigator Name
Giuseppe Carli
Principal Investigator Email
g.carli@aulss8.veneto.it
Contact Person Name
Giuseppe Carli
Contact Person Email
g.carli@aulss8.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Hematology
Principal Investigator Name
Cristina Santoro
Principal Investigator Email
santoro@bce.uniroma1.it
Contact Person Name
Cristina Santoro
Contact Person Email
santoro@bce.uniroma1.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Hematology
Principal Investigator Name
Elena Rossi
Principal Investigator Email
Elena.rossi@unicatt.it
Contact Person Name
Elena Rossi
Contact Person Email
Elena.rossi@unicatt.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UOC Hematology
Principal Investigator Name
Francesca Palandri
Principal Investigator Email
francesca.palandri@unibo.it
Contact Person Name
Francesca Palandri
Contact Person Email
francesca.palandri@unibo.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Hematology and Bone Marrow Transplant
Principal Investigator Name
Fabrizio Pane
Principal Investigator Email
fabrizio.pane@unina.it
Contact Person Name
Fabrizio Pane
Contact Person Email
fabrizio.pane@unina.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Ematologia
Principal Investigator Name
Bruno Fattizzo
Principal Investigator Email
bruno.fattizzo@policlinico.mi.it
Contact Person Name
Bruno Fattizzo
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Dipartimento di Ematologia, Oncologia e Medicina Molecolare
Principal Investigator Name
Monica Carpenedo
Principal Investigator Email
monica.carpenedo@ospedaleniguarda.it
Contact Person Name
Monica Carpenedo
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
UOC Ematologia
Principal Investigator Name
Francesco Zaja
Principal Investigator Email
francesco.zaja@asugi.sanita.fvg.it
Contact Person Name
Francesco Zaja
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Alessandro Lucchesi
Principal Investigator Email
alessandro.lucchesi@irst.emr.it
Contact Person Name
Alessandro Lucchesi
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Ematologia U
Principal Investigator Name
Alessandra Borchiellini
Principal Investigator Email
aborchiellini@cittadellasalute.to.it
Contact Person Name
Alessandra Borchiellini

Germany

Earliest CTIS Part Ii Submission Date
24-09-2025
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
230
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Karolin Trautmann Grill
Principal Investigator Email
Karolin.trautmann@ukdd.de
Contact Person Name
Karolin Trautmann Grill
Contact Person Email
Karolin.trautmann@ukdd.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Marburg UKGM
Principal Investigator Name
Mathias J. Rummel
Principal Investigator Email
Mathias.rummel@innere.med.uni-giessen.de
Contact Person Name
Mathias J. Rummel
Site Name
Goethe University Frankfurt
Department Name
ZIM Med II
Principal Investigator Name
Wolfgang Miesbach
Principal Investigator Email
Wolfgang.miesbach@unimedizin-ffm.de
Contact Person Name
Wolfgang Miesbach
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Charite Universitiy Medicine Berlin
Principal Investigator Name
Marie Luise Huetter-Kroenke
Principal Investigator Email
Luise.huetter-kroenke@charite.de
Contact Person Name
Marie Luise Huetter-Kroenke
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik fuer Haematologie und Stammzelltransplantation
Principal Investigator Name
Alexander Roeth
Principal Investigator Email
Alexander.roeth@uk-essen.de
Contact Person Name
Alexander Roeth
Contact Person Email
Alexander.roeth@uk-essen.de
Site Name
MVZ Leipzig Mitte
Department Name
MVZ Leipzig
Principal Investigator Name
Baerbel Schaedlich
Principal Investigator Email
Baerbel.schaedlich@doceins.de
Contact Person Name
Baerbel Schaedlich
Contact Person Email
Baerbel.schaedlich@doceins.de

Austria

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
226
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Medicine I
Principal Investigator Name
Johanna Gebhart
Principal Investigator Email
Johanna.gebhart@meduniwien.ac.at
Contact Person Name
Johanna Gebhart
Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
3rd Medical Department
Principal Investigator Name
Michael Fillitz
Principal Investigator Email
michael.fillitz@oegk.at
Contact Person Name
Michael Fillitz
Contact Person Email
michael.fillitz@oegk.at

Poland

Earliest CTIS Part Ii Submission Date
16-09-2025
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
241
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddzial Hematologiczny
Principal Investigator Name
Wojciech Homenda
Principal Investigator Email
hematologia@szpital.slupsk.pl
Contact Person Name
Wojciech Homenda
Contact Person Email
hematologia@szpital.slupsk.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Andrej Mital
Principal Investigator Email
amital@uck.gda.pl
Contact Person Name
Andrej Mital
Contact Person Email
amital@uck.gda.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii Ogolnej i Chorob Wewnetrznych
Principal Investigator Name
Tadeusz Robak
Principal Investigator Email
robaktad@csk.umed.lodz.pl
Contact Person Name
Tadeusz Robak
Contact Person Email
robaktad@csk.umed.lodz.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Wojewodzkie Centrum Onkologii
Principal Investigator Name
Hanna Ciepluch
Principal Investigator Email
ciepluch@gumed.edu.pl
Contact Person Name
Hanna Ciepluch
Contact Person Email
ciepluch@gumed.edu.pl
Site Name
Aidport Sp. z o.o.
Principal Investigator Name
Michał Kwiatek
Principal Investigator Email
michal.kwiatek@aidport.pl
Contact Person Name
Michał Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl

Czechia

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
230
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie FNO a LF OUFN Ostrava
Principal Investigator Name
Ivo Demel
Principal Investigator Email
ivo.demel@fno.cz
Contact Person Name
Ivo Demel
Contact Person Email
ivo.demel@fno.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika FN Brno
Principal Investigator Name
Libor Cervinek
Principal Investigator Email
cervinek.libor@fnbrno.cz
Contact Person Name
Libor Cervinek
Contact Person Email
cervinek.libor@fnbrno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interni klinika - klinika hematologie
Principal Investigator Name
Marek Trneny
Principal Investigator Email
trneny@cesnet.cz
Contact Person Name
Marek Trneny
Contact Person Email
trneny@cesnet.cz

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
Rilzabrutinib
Active Substance
RILZABRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Orphan Designation
Yes
Maximum Dose
800 mg (max daily dose amount 800 mg)

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