Clinical trial • Phase III • Immunology|Dermatology

REMIBRUTINIB for Hidradenitis suppurativa (moderate to severe)

Phase III trial of REMIBRUTINIB for Hidradenitis suppurativa (moderate to severe).

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Hidradenitis suppurativa (moderate to severe)
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
22-01-2025
First CTIS Authorization Date
12-05-2025

Trial design

Randomised, placebo (matching film-coated tablet) administered as double-dummy placebo-controlled arm; no active comparator specified. Phase III trial in Germany, Greece, Portugal and others.

Randomised
Yes
Comparator
Placebo (matching film-coated tablet) administered as double-dummy placebo-controlled arm; no active comparator specified.
Target Sample Size
282
Trial Duration For Participant
476

Eligibility

Recruits 282 paediatric patients.

Vulnerable Population
Adolescents are included (participants ≥12 to <18 years). For participants aged ≥ 12 to < 18 years: parent’s or legal guardian’s signed written informed consent and the child’s assent, if appropriate, must be obtained before any assessment is performed. If a participant reaches the age of consent (as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study. For participants aged ≥ 12 to < 18 years: parent’s or legal guardian’s signed written informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.\n- Male and female participants ≥ 12 years of age at the time of signing of the informed consent forms.\n- Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit.\n- Participants with moderate to severe HS at baseline defined as: •\tA total of at least 5 AN, i.e. abscesses and/or inflammatory nodules AND •\tInflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)"}

Exclusion criteria

  • {"criterion_text":"- Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.\n- History of hypersensitivity to any of the study drug constituents.\n- Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility.\n- History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment\n- Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.\n- Any active skin disease or conditions that may interfere with the assessment of HS.\n- Previous exposure to remibrutinib or other BTK inhibitors.\n- Use of other investigational drugs within 5 half-lives, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.\n- Significant bleeding risk or coagulation disorders\n- History of gastrointestinal bleeding.\n- Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.\n- History or current hepatic disease.\n- Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the Investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Achievement of HiSCR50 at Week 16. HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.","definition_or_measurement_approach":"HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline; measured at Week 16."}

Secondary endpoints

  • {"endpoint_text":"- Achievement of AN50 at Week 16. AN50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count compared to baseline","definition_or_measurement_approach":"AN50: at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count compared to baseline; measured at Week 16."}
  • {"endpoint_text":"- Percentage change from baseline in IHS4 at Week 16","definition_or_measurement_approach":"Percent change from baseline in IHS4 score at Week 16."}
  • {"endpoint_text":"- Achievement of HiSCR75 at Week 16. HiSCR75 is defined as at least a 75% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.","definition_or_measurement_approach":"HiSCR75: at least a 75% decrease in AN count with no increase in abscesses or draining tunnels/fistulae compared to baseline; measured at Week 16."}
  • {"endpoint_text":"- Flaring up to Week 16. Flare is defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline.","definition_or_measurement_approach":"Flare: ≥25% increase in AN count with minimum increase of 2 AN relative to baseline; assessed up to Week 16."}
  • {"endpoint_text":"- Achievement of HiSCR50 at Week 8.","definition_or_measurement_approach":"HiSCR50 at Week 8 defined as for primary endpoint but measured at Week 8."}
  • {"endpoint_text":"- Achievement of HiSCR90 at Week 16. HiSCR90 is defined as at least a 90% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.","definition_or_measurement_approach":"HiSCR90: ≥90% decrease in AN count with no increase in abscesses or draining tunnels/fistulae vs baseline; measured at Week 16."}
  • {"endpoint_text":"- Achievement of NRS30 at Week 16, among participants with baseline NRS ≥ 3 (pooled data from studies CLOU064J12301 and CLOU064J12302). NRS30 is defined as at least a 30% reduction and at least 2-unit reduction from baseline in Patient's Global Assessment of Skin Pain - at worst over the past 7 days","definition_or_measurement_approach":"NRS30: ≥30% and ≥2-unit reduction from baseline in Patient's Global Assessment of Skin Pain (worst over past 7 days); assessed at Week 16 among participants with baseline NRS≥3."}
  • {"endpoint_text":"- Occurrence of treatment emergent adverse events and serious adverse events during the study","definition_or_measurement_approach":"Recording and reporting of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study period."}

Recruitment

Planned Sample Size
282
Recruitment Window Months
31
Consent Approach
Adults provide signed informed consent. For participants aged ≥12 to <18 years, parent/legal guardian signed written informed consent and child assent (if appropriate) must be obtained before any assessments. If a participant reaches the legal age of consent during the study, they must sign the study ICF at the next visit. Age-specific ICFs and assent/parent/guardian forms are provided (documents available in country-specific languages and English).

Methods

  • Recruitment advertisements (K2_Advertisements and K1_Recruitment Arrangements documents listed for multiple countries).
  • Third-party patient recruitment via vendors listed in sponsor third parties (e.g., Subject Well Inc. listed with duty 'Patient Recrtuitment').
  • Patient convenience and support services via vendors (e.g., Greenphire LLC listed with duty 'Patient Convenience').

Geography

Total Number Of Sites
60
Total Number Of Participants
205

Germany

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
362
Number Of Sites
17
Number Of Participants
75

Sites

Site Name
Hautaerzte Zentrum Hannover
Department Name
3116: Practice
Principal Investigator Name
Florian Schenck
Principal Investigator Email
schenck@hautaerzte-zentrum.de
Contact Person Name
Florian Schenck
Contact Person Email
schenck@hautaerzte-zentrum.de
Site Name
Praxis Dr. med. Abdou Zarzour
Department Name
3113: Practice
Principal Investigator Name
Abdou Zarzour
Principal Investigator Email
Zarzour@gmx.de
Contact Person Name
Abdou Zarzour
Contact Person Email
Zarzour@gmx.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
3107: Psoriasis-Zentrum-Kiel Klinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Sascha Gerdes
Principal Investigator Email
Sascha.Gerdes@uksh.de
Contact Person Name
Sascha Gerdes
Contact Person Email
Sascha.Gerdes@uksh.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
3105: Hautklinik
Principal Investigator Name
Lukas Sollfrank
Principal Investigator Email
Lukas.sollfrank@uk-erlangen.de
Contact Person Name
Lukas Sollfrank
Contact Person Email
Lukas.sollfrank@uk-erlangen.de
Site Name
ISA Interdisciplinary Study Association GmbH
Department Name
3110
Principal Investigator Name
Margrit Simon
Principal Investigator Email
msimon@isa-research.de
Contact Person Name
Margrit Simon
Contact Person Email
msimon@isa-research.de
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
3109: Klinik fuer Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Falk Bechara
Principal Investigator Email
Falk.bechara@klinikum-bochum.de
Contact Person Name
Falk Bechara
Site Name
Universitaet Muenster
Department Name
3108: Klinik für Hautkrankheiten
Principal Investigator Name
Nina Magnolo
Principal Investigator Email
Nina.Magnolo@ukmuenster.de
Contact Person Name
Nina Magnolo
Contact Person Email
Nina.Magnolo@ukmuenster.de
Site Name
Beldio Research GmbH
Department Name
3119: Beldio Research GmbH
Principal Investigator Name
Nicolai Treiber
Principal Investigator Email
Treiber@beldio.com
Contact Person Name
Nicolai Treiber
Contact Person Email
Treiber@beldio.com
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
3101: Hautklinik u Poliklinik d Universitaetsmedizin Mainz/ Clinical Research Center
Principal Investigator Name
Petra Staubach-Renz
Principal Investigator Email
petra.staubach@unimedizin-mainz.de
Contact Person Name
Petra Staubach-Renz
Site Name
Studienzentrum Dr. med. Beate Schwarz
Department Name
3103: Practice
Principal Investigator Name
Beate Schwarz
Principal Investigator Email
beate@hautarzt-langenau.de
Contact Person Name
Beate Schwarz
Contact Person Email
beate@hautarzt-langenau.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
3102: Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studienzentrum
Principal Investigator Name
Sonja Molin
Principal Investigator Email
sonja-christine.molin@charite.de
Contact Person Name
Sonja Molin
Site Name
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
Department Name
3120: Klinik für Dermatologie
Principal Investigator Name
Andreas Karl Kleinheinz
Principal Investigator Email
Andreas.Kleinheinz@elbekliniken.de
Contact Person Name
Andreas Karl Kleinheinz
Site Name
Eurofins bioskin GmbH
Department Name
3115
Principal Investigator Name
Swarna Ekanayake-Bohlig
Principal Investigator Email
Swarna.Ekanayake@cpt.eurofinseu.com
Contact Person Name
Swarna Ekanayake-Bohlig
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
3118: Klinik fuer Dermatologie
Principal Investigator Name
Roland Aschoff
Principal Investigator Email
Roland.Aschoff@uniklinikum-dresden.de
Contact Person Name
Roland Aschoff
Site Name
Universitaetsklinikum Bonn AöR
Department Name
3114: Klinik für Dermatologie und Allergologie
Principal Investigator Name
Jörg Wenzel
Principal Investigator Email
joerg.wenzel@ukbonn.de
Contact Person Name
Jörg Wenzel
Contact Person Email
joerg.wenzel@ukbonn.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
3117: Klinik für Dermatologie und Allergologie
Principal Investigator Name
Amir Yazdi
Principal Investigator Email
Ayazdi@ukaachen.de
Contact Person Name
Amir Yazdi
Contact Person Email
Ayazdi@ukaachen.de
Site Name
Klinikum Darmstadt GmbH
Department Name
3106: Dermatology
Principal Investigator Name
Mana Zur Brügge
Contact Person Name
Mana Zur Brügge

Greece

Earliest CTIS Part Ii Submission Date
04-02-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
437
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
3152: 1st Dermatology and Venereology Department
Principal Investigator Name
Eleni Sotiriou
Principal Investigator Email
elenasotiriou@yahoo.gr
Contact Person Name
Eleni Sotiriou
Contact Person Email
elenasotiriou@yahoo.gr
Site Name
University General Hospital Of Heraklion
Department Name
3153: Department of Dermatology
Principal Investigator Name
Konstantinos Krasagakis
Principal Investigator Email
krasagak@med.uoc.gr
Contact Person Name
Konstantinos Krasagakis
Contact Person Email
krasagak@med.uoc.gr
Site Name
University General Hospital Attikon
Department Name
3151: 4th Department of Internal Medicine
Principal Investigator Name
Evangelos Giamarellos Bourboulis
Principal Investigator Email
egiamarel@med.uoa.gr
Contact Person Name
Evangelos Giamarellos Bourboulis
Contact Person Email
egiamarel@med.uoa.gr

Portugal

Earliest CTIS Part Ii Submission Date
21-04-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
358
Number Of Sites
6
Number Of Participants
19

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
3305: Serviço de Dermatologia
Principal Investigator Name
Ricardo Vieira
Principal Investigator Email
6817@ulscoimbra.min-saude.pt
Contact Person Name
Ricardo Vieira
Contact Person Email
6817@ulscoimbra.min-saude.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
3301: Serviço de Dermatologia
Principal Investigator Name
Celeste Brito
Principal Investigator Email
celeste.brito@hb.min-saude.pt
Contact Person Name
Celeste Brito
Contact Person Email
celeste.brito@hb.min-saude.pt
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
3306: Serviço de Dermatologia
Principal Investigator Name
Rita Figueiredo Pimenta
Principal Investigator Email
rita.pimenta@hgo.min-saude.pt
Contact Person Name
Rita Figueiredo Pimenta
Contact Person Email
rita.pimenta@hgo.min-saude.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
3303: Serviço de Dermatologia
Principal Investigator Name
Joana Cabete
Principal Investigator Email
Joana.cabete@ulssjose.min-saude.pt
Contact Person Name
Joana Cabete
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
3304: Serviço de Dermatologia
Principal Investigator Name
Inês Lobo
Principal Investigator Email
u08253@chporto.min-saude.pt
Contact Person Name
Inês Lobo
Contact Person Email
u08253@chporto.min-saude.pt
Site Name
Hospital Cuf Descobertas S.A.
Department Name
3302: Serviço de Dermatologia
Principal Investigator Name
Pedro Mendes Bastos
Principal Investigator Email
pedro.mm.bastos@cuf.pt
Contact Person Name
Pedro Mendes Bastos
Contact Person Email
pedro.mm.bastos@cuf.pt

Bulgaria

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
369
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
ASMC IPSMC Skin And Venereal Diseases
Department Name
3001
Principal Investigator Name
Ivan Botev
Principal Investigator Email
botev2@yahoo.com
Contact Person Name
Ivan Botev
Contact Person Email
botev2@yahoo.com
Site Name
Medical Center Kordis OOD
Department Name
3003
Principal Investigator Name
Dimitar Gospodinov
Principal Investigator Email
dkg@abv.bg
Contact Person Name
Dimitar Gospodinov
Contact Person Email
dkg@abv.bg
Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
3004: Clinic of Dermatology and Venereology disease
Principal Investigator Name
Ivan Bogdanov
Principal Investigator Email
iv.bogdanov@gmail.com
Contact Person Name
Ivan Bogdanov
Contact Person Email
iv.bogdanov@gmail.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
3002: Dermatology and Venereology clinic
Principal Investigator Name
Evgenia Hristakieva
Principal Investigator Email
ehristakieva@gmail.com
Contact Person Name
Evgenia Hristakieva
Contact Person Email
ehristakieva@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
369
Number Of Sites
10
Number Of Participants
39

Sites

Site Name
Hospital Universitario De Fuenlabrada
Department Name
3451: Servicio Dermatología
Principal Investigator Name
Alberto Romero Maté
Principal Investigator Email
romerom@salud.madrid.org
Contact Person Name
Alberto Romero Maté
Contact Person Email
romerom@salud.madrid.org
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
3452: Servicio Dermatología
Principal Investigator Name
Almudena Mateu Puchades
Principal Investigator Email
mateu_alm@gva.es
Contact Person Name
Almudena Mateu Puchades
Contact Person Email
mateu_alm@gva.es
Site Name
Hospital General Universitario De Valencia
Department Name
3460: Servicio Dermatología
Principal Investigator Name
José María Ortiz Salvador
Principal Investigator Email
ortiz_jossal@gva.es
Contact Person Name
José María Ortiz Salvador
Contact Person Email
ortiz_jossal@gva.es
Site Name
Hospital Universitario Puerta Del Mar
Department Name
3455: Servicio Dermatología
Principal Investigator Name
David Jimenez Gallo
Contact Person Name
David Jimenez Gallo
Site Name
Hospital Universitario La Paz
Department Name
3459: Servicio Dermatología
Principal Investigator Name
Pedro Herranz Pinto
Principal Investigator Email
pedro.herranz@salud.madrid.org
Contact Person Name
Pedro Herranz Pinto
Contact Person Email
pedro.herranz@salud.madrid.org
Site Name
Parc Tauli Hospital Universitari
Department Name
3458: Servicio Dermatología
Principal Investigator Name
Patricia Garbayo Salmons
Principal Investigator Email
pgarbayo.parctauli@gmail.com
Contact Person Name
Patricia Garbayo Salmons
Contact Person Email
pgarbayo.parctauli@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
3454: Servicio Dermatología
Principal Investigator Name
Cristina Ciudad Blanco
Principal Investigator Email
cristina.ciudad@salud.madrid.org
Contact Person Name
Cristina Ciudad Blanco
Site Name
Hospital Germans Trias I Pujol
Department Name
3457: Servicio Dermatología
Principal Investigator Name
Julio Bassas Vila
Principal Investigator Email
jbassas@igtp.cat
Contact Person Name
Julio Bassas Vila
Contact Person Email
jbassas@igtp.cat
Site Name
Hospital Del Mar
Department Name
3456: Servicio Dermatología
Principal Investigator Name
Gemma Martín Ezquerra
Principal Investigator Email
GMartin@parcdesalutmar.cat
Contact Person Name
Gemma Martín Ezquerra
Contact Person Email
GMartin@parcdesalutmar.cat
Site Name
Hospital De Manises
Department Name
3453: Servicio Dermatología
Principal Investigator Name
Antonio Martorell Calatayud
Principal Investigator Email
antmarto@hotmail.com
Contact Person Name
Antonio Martorell Calatayud
Contact Person Email
antmarto@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
374
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
Department Name
3252
Principal Investigator Name
Joanna Narbutt
Principal Investigator Email
joanna.narbutt@onet.pl
Contact Person Name
Joanna Narbutt
Contact Person Email
joanna.narbutt@onet.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
3251: Klinika Dermatologii, Wenerologii i Alergologii
Principal Investigator Name
Roman Nowicki
Principal Investigator Email
nowicki@gumed.edu.pl
Contact Person Name
Roman Nowicki
Contact Person Email
nowicki@gumed.edu.pl
Site Name
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Department Name
3253: Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunodermatologii
Principal Investigator Name
Luiza Marek-Jozefowicz
Principal Investigator Email
lui06@interia.pl
Contact Person Name
Luiza Marek-Jozefowicz
Contact Person Email
lui06@interia.pl

Italy

Earliest CTIS Part Ii Submission Date
04-02-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
440
Number Of Sites
11
Number Of Participants
22

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
3201: U.O.C. Dermatologia
Principal Investigator Name
Ketty Peris
Principal Investigator Email
ketty.peris@unicatt.it
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
3210: U.O.C. Clinica Dermatologica
Principal Investigator Name
Giuseppe Micali
Principal Investigator Email
gmicalitrial@gmail.com
Contact Person Name
Giuseppe Micali
Contact Person Email
gmicalitrial@gmail.com
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
3202: S.C. Dermatologia
Principal Investigator Name
Cristina Magnoni
Principal Investigator Email
cristina.magnoni@unimore.it
Contact Person Name
Cristina Magnoni
Contact Person Email
cristina.magnoni@unimore.it
Site Name
University Hospital Of Ferrara
Department Name
3209: U.O. di Dermatologia
Principal Investigator Name
Alessandro Borghi
Principal Investigator Email
brglsn1@unife.it
Contact Person Name
Alessandro Borghi
Contact Person Email
brglsn1@unife.it
Site Name
Azienda USL Toscana Centro
Department Name
3206: U.O. Dermatologia II
Principal Investigator Name
Francesca Prignano
Principal Investigator Email
francesca.prignano@unifi.it
Contact Person Name
Francesca Prignano
Contact Person Email
francesca.prignano@unifi.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
3207: U.O.C. Dermatologia
Principal Investigator Name
Marco Romanelli
Principal Investigator Email
m.romanelli@med.unipi.it
Contact Person Name
Marco Romanelli
Contact Person Email
m.romanelli@med.unipi.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
3205: U.O. Dermatologia
Principal Investigator Name
Marina Venturini
Principal Investigator Email
marina.venturini@unibs.it
Contact Person Name
Marina Venturini
Contact Person Email
marina.venturini@unibs.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
3212: U.O. Dermatologia e Venereologia
Principal Investigator Name
Mario Valenti
Principal Investigator Email
mario.valenti@hunimed.eu
Contact Person Name
Mario Valenti
Contact Person Email
mario.valenti@hunimed.eu
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
3204: S.C. Dermatologia
Principal Investigator Name
Angelo Valerio Marzano
Principal Investigator Email
angelo.marzano@unimi.it
Contact Person Name
Angelo Valerio Marzano
Contact Person Email
angelo.marzano@unimi.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
3213: SOD Clinica di Dermatologia
Principal Investigator Name
Elisa Molinelli
Principal Investigator Email
elisa.molinelli@ospedaliriuniti.marche.it
Contact Person Name
Elisa Molinelli
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
3211: Osp. Dermatologico San Lazzaro
Principal Investigator Name
Simone Ribero
Principal Investigator Email
simone.ribero@unito.it
Contact Person Name
Simone Ribero
Contact Person Email
simone.ribero@unito.it

Slovakia

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
369
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Cliniq s.r.o.
Department Name
3353: Dermatovenerologická ambulancia
Principal Investigator Name
Barbora Ondrak
Principal Investigator Email
ondrak@polibez.sk
Contact Person Name
Barbora Ondrak
Contact Person Email
ondrak@polibez.sk
Site Name
University Hospital Bratislava
Department Name
3355: Dermatovenerologická klinika
Principal Investigator Name
Martina Part
Principal Investigator Email
martina.part@icloud.com
Contact Person Name
Martina Part
Contact Person Email
martina.part@icloud.com
Site Name
Fakultna Nemocnica Trnava
Department Name
3351: Dermatovenerologické oddelenie
Principal Investigator Name
Peter Kozub
Principal Investigator Email
peter.kozub.derm@gmail.com
Contact Person Name
Peter Kozub
Contact Person Email
peter.kozub.derm@gmail.com
Site Name
Medikard s.r.o.
Department Name
3354: Kožná ambulancia Youderm
Principal Investigator Name
Tomáš Uhrin
Principal Investigator Email
tomasuhrin404@gmail.com
Contact Person Name
Tomáš Uhrin
Contact Person Email
tomasuhrin404@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
07-05-2025
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
364
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Region Sjaelland
Department Name
3053: Dermatologisk afdeling
Principal Investigator Name
Peter Theut Riis
Principal Investigator Email
pmik@regionsjaelland.dk
Contact Person Name
Peter Theut Riis
Contact Person Email
pmik@regionsjaelland.dk
Site Name
Region Hovedstaden
Department Name
3051: Dermatologisk-Venerologisk Afdeling og videncenter for sårheling D/S
Principal Investigator Name
Simon Francis Thomsen
Principal Investigator Email
simon.francis.thomsen.02@regionh.dk
Contact Person Name
Simon Francis Thomsen

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsorDuties codes: 1; contact eu_clinical_trials_information@iqvia.com
Name
Parexel International (IRL) Limited
Responsibilities
sponsorDuties codes: 12
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: 1
Name
PRA Hellas CRO A.E.
Responsibilities
sponsorDuties codes: 1
Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: 1

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1 (contact eu_clinical_trials_information@iqvia.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"PRO management, PRO licensing and translations, data collection via tablet","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Subject Well Inc.","duties_or_roles":"Patient Recrtuitment","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Q Squared Solutions (Beijing) Co. Ltd.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Labor Dr. Spranger","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1 (duplicate entry)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Convenience","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"PRO formatting and translations and Trial Feedback Questionnaire","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photography","organisation_type":"Pharmaceutical company"}
  • {"country":"Bulgaria","full_name":"S & D Pharma Logistics BG EOOD","duties_or_roles":"Storage and destruction of IMPD.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG reading","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Freezer and cooler bag supplies","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LOU064
Active Substance
REMIBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
Placebo to Remibrutinib (LOU064) 0 mg matching 00 mg film-coated tablet
Modality
Other

Related trials

Other published trials that may interest you.