Clinical trial • Phase III • Musculoskeletal

FILGOTINIB for Polyarticular juvenile idiopathic arthritis (pJIA)

Phase III trial of FILGOTINIB for Polyarticular juvenile idiopathic arthritis (pJIA). open-label, none/not specified-controlled. 65 participants.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Polyarticular juvenile idiopathic arthritis (pJIA)
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
26-11-2025
First CTIS Authorization Date
07-04-2026

Trial design

open-label, none/not specified-controlled Phase III trial across 46 sites in Belgium, Bulgaria, Czechia and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
65
Trial Duration For Participant
540

Eligibility

Recruits 65 paediatric patients.

Vulnerable Population
Participants are children and adolescents aged 8 to <18 years. Consent is provided by the parent/legal guardian and the participant must sign assent where required by local regulation (see inclusion criterion: "Subject and/or parent/legal guardian must be able and willing to comply ... and must sign and date the ICF and assent (if required per local regulation) ..."). Age-appropriate assent and information materials are provided (assent for non-readers, assent for young readers ages 8–12, assent for adolescents 12–<18, assent/turning-18 guidance), parent/guardian ICFs, and pregnancy information/ICF materials for adolescent girls. Country- and language-specific ICF/assent documents and recruitment materials are provided (multiple country translations and recruitment-arrangement documents listed per Member State).

Inclusion criteria

  • {"criterion_text":"- Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board, prior to any screening evaluations.\n- Female or male subject 8 to <18 years of age, on the date of signing the informed consent and assent (per local regulation).\n- Subject must meet the ILAR classification and have moderately to severely active disease for one of the following categories that is not adequately controlled with his/her current therapy (see Protocol Appendix 1 for disease activity assessment criteria): • Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease) • RF-positive polyarthritis • RF-negative polyarthritis • PsA • ERA\n- Subject with intolerance or a history of inadequate response to at least one of the following medications for the treatment of pJIA, administered for at least 3 months, based on current treatment guidelines: conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs; including methotrexate) and/or biologic disease modifying anti-rheumatic drugs (bDMARDS) administered per local label, and/or non-steroidal anti-inflammatory drugs for ERA and PsA subtypes.\n- Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the protocol."}

Exclusion criteria

  • {"criterion_text":"- Subject with a body weight <15 kg.\n- Subject with persistent oligoarthritis (i.e. affecting not more than 4 joints throughout the disease course).\n- Subject with undifferentiated arthritis.\n- Subject with anterior uveitis (active or uncontrolled) ≤12 weeks prior to baseline.\n- Subject with systemic JIA.\n- Subject with any other rheumatic disease, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus).\n- Subject has any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.\n- Subject has an active infection.\n- Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation (up to approximately Week 22 or throughout the duration of the study)","definition_or_measurement_approach":"Safety assessment by recording frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to discontinuation up to ~Week 22 or throughout study duration (as stated in endpoint)."}

Secondary endpoints

  • {"endpoint_text":"- − Percentage of subjects with juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response at Week 12 and Week 18 − Percentage of subjects with JIA ACR inactive disease at Week 12 and Week 18 − Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 erythrocyte sedimentation rate (ESR) and JADAS-27 C-reactive protein (CRP) at Week 12 and Week 18","definition_or_measurement_approach":"Clinical efficacy measured by JIA ACR response rates (ACR 30) and ACR inactive disease status at Weeks 12 and 18; change from baseline in JADAS-27 using ESR and CRP at Weeks 12 and 18."}
  • {"endpoint_text":"- Incidence of uveitis at various timepoints (including occurrence, type, and severity)","definition_or_measurement_approach":"Uveitis events captured at prespecified timepoints, recording occurrence, type and severity."}
  • {"endpoint_text":"- PK parameters of filgotinib and its primary metabolite GS-829845 (including maximum observed plasma concentration at steady-state [Cmax,ss], area under the plasma concentration-time curve over the dosing interval at steady-state [AUC0-24,ss], and area under the plasma concentration-time curve over the dosing interval at steady-state for the effective exposure [AUCeff,ss])","definition_or_measurement_approach":"Pharmacokinetic sampling and analysis to determine Cmax,ss, AUC0-24,ss, AUCeff,ss for filgotinib and GS-829845."}
  • {"endpoint_text":"- Acceptability of the age-appropriate pediatric formulation and the adult commercially developed film-coated tablet formulation assessed by Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P)","definition_or_measurement_approach":"Acceptability measured using the POMAQ-P questionnaire completed by patients to assess formulation acceptability."}

Recruitment

Planned Sample Size
65
Recruitment Window Months
24
Consent Approach
Informed consent is provided by the parent/legal guardian and the subject where applicable; assent is required per local regulation. Age-appropriate assent forms and information materials are provided (assent for non-readers, assent for young readers ages 8–12, assent for adolescents 12–<18, 'turning 18' materials). Parent/guardian ICFs, pregnancy ICF and pregnancy handouts for adolescent girls are provided. Multiple language and country-specific versions of ICF/assent/recruitment materials are available as indicated in the submission (e.g. English, French, Dutch, Bulgarian, Czech, German, Greek, Hungarian, Italian, Polish, Spanish and others as per Member State documents).

Methods

  • Physician referral letters (country-specific physician referral letter documents listed: e.g. Physician Referral Letter _English/Dutch/French and country-specific versions).
  • Participant brochures / patient brochures (country-specific Participant Brochure documents listed).
  • Recruitment arrangements documents (K1 documents) per Member State describing local recruitment procedures and materials.
  • Use of site/hospital-based recruitment via clinical sites listed (pediatric rheumatology departments).

Geography

Total Number Of Sites
46
Total Number Of Participants
57

Belgium

Earliest CTIS Part Ii Submission Date
18-03-2026
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
20
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Rheumatology
Principal Investigator Name
Rik Joos
Principal Investigator Email
rik.joos@zas.be
Contact Person Name
Rik Joos
Contact Person Email
rik.joos@zas.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Rheumatology
Principal Investigator Name
Benson Ogunjimi
Principal Investigator Email
benson.ogunjimi@uza.be
Contact Person Name
Benson Ogunjimi
Contact Person Email
benson.ogunjimi@uza.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Rheumatology
Principal Investigator Name
Joke Dehoorne
Principal Investigator Email
joke.dehoorne@uzgent.be
Contact Person Name
Joke Dehoorne
Contact Person Email
joke.dehoorne@uzgent.be
Site Name
UZ Leuven
Department Name
Rheumatology
Principal Investigator Name
Lien De Somer
Principal Investigator Email
lien.desomer@uzleuven.be
Contact Person Name
Lien De Somer
Contact Person Email
lien.desomer@uzleuven.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Rheumatology
Principal Investigator Name
Benoît Florkin
Principal Investigator Email
benoit.florkin@chrcitadelle.be
Contact Person Name
Benoît Florkin
Contact Person Email
benoit.florkin@chrcitadelle.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Rheumatology
Principal Investigator Name
Patrick Durez
Principal Investigator Email
patrick.durez@saintluc.uclouvain.be
Contact Person Name
Patrick Durez

Bulgaria

Earliest CTIS Part Ii Submission Date
20-03-2026
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
25
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Pediatrics
Principal Investigator Name
Krastina Stefanova-Kelly
Principal Investigator Email
krastinakelly@yahoo.co.uk
Contact Person Name
Krastina Stefanova-Kelly
Contact Person Email
krastinakelly@yahoo.co.uk
Site Name
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev
Department Name
Clinic of Pediatric Rheumatology
Principal Investigator Name
Katya Temelkova
Principal Investigator Email
temelkovakatya@gmail.com
Contact Person Name
Katya Temelkova
Contact Person Email
temelkovakatya@gmail.com
Site Name
Medical Center For Specialized Medical Care For Cardiovascular Diseases EAD
Principal Investigator Name
Stefan Stefanov
Principal Investigator Email
prof.s.stefanov.md@gmail.com
Contact Person Name
Stefan Stefanov
Contact Person Email
prof.s.stefanov.md@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
05-03-2026
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
34
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Klinika pediatrie a dědičných poruch metabolismu
Principal Investigator Name
Pavla Doležalová
Principal Investigator Email
pavla.dolezalova@vfn.cz
Contact Person Name
Pavla Doležalová
Contact Person Email
pavla.dolezalova@vfn.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Pediatrická klinika
Principal Investigator Name
Marcel Schüller
Principal Investigator Email
Schuller.Marcel@fnbrno.cz
Contact Person Name
Marcel Schüller
Contact Person Email
Schuller.Marcel@fnbrno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Oddělení revmatologie dětí a dospělých
Principal Investigator Name
Rudolf Horváth
Principal Investigator Email
rudolf.horvath@fnmotol.cz
Contact Person Name
Rudolf Horváth
Contact Person Email
rudolf.horvath@fnmotol.cz
Site Name
University Hospital Olomouc
Department Name
Dětská klinika, Dětská revmatologie
Principal Investigator Name
Kateřina Bouchalová
Principal Investigator Email
katerina.bouchalova@fnol.cz
Contact Person Name
Kateřina Bouchalová
Contact Person Email
katerina.bouchalova@fnol.cz

France

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
32
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pediatric Immunology-Hematology and Rheumatology
Principal Investigator Name
Pierre QUARTIER DIT MAIRE
Principal Investigator Email
pierre.quartier@aphp.fr
Contact Person Name
Pierre QUARTIER DIT MAIRE
Contact Person Email
pierre.quartier@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Immuno-Hematology and Rheumatology
Principal Investigator Name
Isabelle KONE-PAUT
Principal Investigator Email
isabelle.kone-paut@aphp.fr
Contact Person Name
Isabelle KONE-PAUT
Contact Person Email
isabelle.kone-paut@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
General pediatrics
Principal Investigator Name
Aurelia CARBASSE
Principal Investigator Email
a-carbasse@chu-montpellier.fr
Contact Person Name
Aurelia CARBASSE
Contact Person Email
a-carbasse@chu-montpellier.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Pediatric Rheumatology and Pediatric pain
Principal Investigator Name
Florence UETTWILLER
Principal Investigator Email
f.uettwiller@chu-tours.fr
Contact Person Name
Florence UETTWILLER
Contact Person Email
f.uettwiller@chu-tours.fr

Germany

Earliest CTIS Part Ii Submission Date
20-03-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
20
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
paediatric rheumatology
Principal Investigator Name
Kirsten Minden
Principal Investigator Email
kirsten.minden@charite.de
Contact Person Name
Kirsten Minden
Contact Person Email
kirsten.minden@charite.de
Site Name
Hamburger Zentrum fuer Kinder und Jugendrheumatologie
Department Name
Pediatric rheumatology
Principal Investigator Name
Ivan Foeldvari
Principal Investigator Email
foeldvari@t-online.de
Contact Person Name
Ivan Foeldvari
Contact Person Email
foeldvari@t-online.de
Site Name
Klinikum St. Georg gGmbH
Department Name
paediatric rheumatology
Principal Investigator Name
Maria Fasshauer
Principal Investigator Email
maria.fasshauer@sanktgeorg.de
Contact Person Name
Maria Fasshauer
Contact Person Email
maria.fasshauer@sanktgeorg.de
Site Name
Asklepios Klinik Sankt Augustin GmbH
Department Name
Pediatric rheumatology, immunology
Principal Investigator Name
Gerd Horneff
Principal Investigator Email
g.horneff@asklepios.com
Contact Person Name
Gerd Horneff
Contact Person Email
g.horneff@asklepios.com

Greece

Earliest CTIS Part Ii Submission Date
19-01-2026
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
79
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Nosokomeio Paidon I Agia Sofia
Department Name
1st University Pediatric Clinic
Principal Investigator Name
Elena Tsitsami
Principal Investigator Email
elena@tsitsamis.gr
Contact Person Name
Elena Tsitsami
Contact Person Email
elena@tsitsamis.gr
Site Name
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Department Name
Second Department of Pediatrics
Principal Investigator Name
Despoina Maritsi
Principal Investigator Email
dmaritsi@yahoo.co.uk
Contact Person Name
Despoina Maritsi
Contact Person Email
dmaritsi@yahoo.co.uk
Site Name
Hippokration Hospital
Department Name
1st Department of Pediatrics
Principal Investigator Name
Vasiliki Sgouropoulou
Principal Investigator Email
vsgouro@auth.gr
Contact Person Name
Vasiliki Sgouropoulou
Contact Person Email
vsgouro@auth.gr

Hungary

Earliest CTIS Part Ii Submission Date
03-02-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
69
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
University Of Szeged
Department Name
Rheumatology and Immunology
Principal Investigator Name
Viktoria Sumegi
Principal Investigator Email
sumegi.viktoria@med.u.szeged.hu
Contact Person Name
Viktoria Sumegi
Site Name
Semmelweis University
Department Name
Gyermekgyógyászati Klinika Tűzoltó utcai részleg
Principal Investigator Name
Tamas Constantin
Principal Investigator Email
constantin.tamas@semmelweis.hu
Contact Person Name
Tamas Constantin
Contact Person Email
constantin.tamas@semmelweis.hu
Site Name
University Of Pecs
Department Name
Pediatric Clinic
Principal Investigator Name
Bernadett Mosdosi
Principal Investigator Email
mosdosi.bernadett@pte.hu
Contact Person Name
Bernadett Mosdosi
Contact Person Email
mosdosi.bernadett@pte.hu

Italy

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
33
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
Pediatric Rheumatology
Principal Investigator Name
Achille Marino
Principal Investigator Email
achille.marino@asst-pini-cto.it
Contact Person Name
Achille Marino
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Pediatria Immunoreumatologia
Principal Investigator Name
Stefano Lanni
Principal Investigator Email
stefano.lanni@policlinico.mi.it
Contact Person Name
Stefano Lanni
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
UOC pediatria
Principal Investigator Name
Francesca Biscaro
Principal Investigator Email
francesca.biscaro@aulss2.veneto.it
Contact Person Name
Francesca Biscaro
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Pediatric Rheumatology
Principal Investigator Name
Gabriele Simonini
Principal Investigator Email
gabriele.simonini@unifi.it
Contact Person Name
Gabriele Simonini
Contact Person Email
gabriele.simonini@unifi.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Pediatric
Principal Investigator Name
Adele Civino
Principal Investigator Email
adele.civino@asl.lecce.it
Contact Person Name
Adele Civino
Contact Person Email
adele.civino@asl.lecce.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Pediatric Rheumatology
Principal Investigator Name
Giovanni Conti
Principal Investigator Email
gconti@unime.it
Contact Person Name
Giovanni Conti
Contact Person Email
gconti@unime.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Pediatric Rheumatology
Principal Investigator Name
Alessandro Consolaro
Principal Investigator Email
alessandroconsolaro@gaslini.org
Contact Person Name
Alessandro Consolaro
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Pediatric Rheumatology

Spain

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
65
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Rheumatology
Principal Investigator Name
Antonio Mera Varela
Principal Investigator Email
antonio.mera.varela@sergas.es
Contact Person Name
Antonio Mera Varela
Contact Person Email
antonio.mera.varela@sergas.es
Site Name
Hospital Universitario La Paz
Department Name
Pediatric Rheumatology
Principal Investigator Name
Rosa Maria Alcobendas Rueda
Principal Investigator Email
rosaalcobendasrueda@gmail.com
Contact Person Name
Rosa Maria Alcobendas Rueda
Contact Person Email
rosaalcobendasrueda@gmail.com
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Rheumatology
Principal Investigator Name
Jordi Anton Lopez
Principal Investigator Email
janton@sjdhospitalbarcelona.org
Contact Person Name
Jordi Anton Lopez
Site Name
Hospital HM Nens
Department Name
Pediatric Rheumatology
Principal Investigator Name
Violeta Bittermann
Principal Investigator Email
vbittermann@fundacionhm.com
Contact Person Name
Violeta Bittermann
Contact Person Email
vbittermann@fundacionhm.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric Rheumatology
Principal Investigator Name
Lucia Lacruz Perez
Principal Investigator Email
lacruz_lucper@gva.es
Contact Person Name
Lucia Lacruz Perez
Contact Person Email
lacruz_lucper@gva.es
Site Name
Hospital Universitario De Cruces
Department Name
Pediatrics
Principal Investigator Name
Maria del Carmen Pinedo Gago
Principal Investigator Email
MARIADELCARMEN.PINEDOGAGO@osakidetza.eus
Contact Person Name
Maria del Carmen Pinedo Gago
Site Name
Hospital Universitari Vall D Hebron
Department Name
Rheumatology
Principal Investigator Name
Estefania Moreno Ruzafa
Principal Investigator Email
estefania.moreno@vallhebron.cat
Contact Person Name
Estefania Moreno Ruzafa

Poland

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
34
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Centrum Medyczne Justmed Sp. z o.o.
Department Name
ETG JustMed
Principal Investigator Name
Marta Szwarc-Bronikowska
Principal Investigator Email
m.szwarcbronikowska@etg-network.com
Contact Person Name
Marta Szwarc-Bronikowska
Site Name
Centrum Medyczne "Hipokrates" S.C. Elżbieta i Grzegorz Grześk
Department Name
Centrum Medyczne "Hipokrates" S.C Elżbieta i Grzegorz Grześk
Principal Investigator Name
Elżbieta Grześk
Principal Investigator Email
hipokrates@farmepo.com
Contact Person Name
Elżbieta Grześk
Contact Person Email
hipokrates@farmepo.com
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Department Name
Małopolskie Badania Kliniczne
Principal Investigator Name
Zbigniew Żuber
Principal Investigator Email
zbyszekzuber@interia.pl
Contact Person Name
Zbigniew Żuber
Contact Person Email
zbyszekzuber@interia.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Toruń
Principal Investigator Name
Sławomir Jeka
Principal Investigator Email
s.jeka@wp.pl
Contact Person Name
Sławomir Jeka
Contact Person Email
s.jeka@wp.pl

Sponsor

Primary sponsor

Full Name
Alfasigma S.p.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Italy

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsorDuties codes: 1,10,12,2,5,8 (as listed in submission)
Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
sponsorDuties codes: 1,8 (as listed in submission)
Name
Almac Clinical Services Limited
Responsibilities
Medicinal product production, QP certification and release, overall distribution and destruction of reconciled IMP
Name
QPS Netherlands B.V.
Responsibilities
sponsorDuties code 4
Name
Labcorp Central Laboratory Services SARL
Responsibilities
sponsorDuties code 4 (central laboratory services)

Third parties

  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"equipment supply (code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Medicinal product production, QP certification and release, overall distribution and destruction of reconciled IMP (code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,10,12,2,5,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code 3","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
GLPG0634
Active Substance
FILGOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
prodAuthStatus: 1 (no marketing authorisation indicated in productDictionaryInfo)
Maximum Dose
100 mg (maxDailyDoseAmount: 100)
Investigational Product Name
Jyseleca 100 mg film-coated tablets
Active Substance
FILGOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised (marketingAuthNumber: EU/1/20/1480/001; prodAuthStatus: 2)
Maximum Dose
100 mg (maxDailyDoseAmount: 100)
Investigational Product Name
Jyseleca 200 mg film-coated tablets
Active Substance
FILGOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised (marketingAuthNumber: EU/1/20/1480/003; prodAuthStatus: 2)
Maximum Dose
200 mg (maxDailyDoseAmount: 200)

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