Clinical trial • Phase III • Gastroenterology

Filgotinib for Ulcerative colitis

Phase III trial of Filgotinib for Ulcerative colitis. open-label. 20 participants.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
17-07-2024
First CTIS Authorization Date
11-11-2024

Trial design

open-label Phase III trial in Ireland, Belgium, Romania and others.

Open Label
Yes
Target Sample Size
20
Trial Duration For Participant
434

Eligibility

Recruits 20 paediatric patients.

Pregnancy Exclusion
Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.
Vulnerable Population
Paediatric participants (age 8 to <18 years) are included. Parental/guardian informed consent is required and age-appropriate assent is used: assent forms for non-readers, early readers, and young adult readers are provided, as well as parental ICFs. There are dedicated adolescent pregnancy assent/ICF documents and guidance for participants turning 18. eConsent materials (videos, participation invitation emails, on-screen text and security/data custody information) are available to support consent/assent processes.

Inclusion criteria

  • {"criterion_text":"- Subject must have a minimum BW of 15 kg\n- Subject: a.\thas documented diagnosis of UC with a minimum duration of 3 months, b.\thas mMCS of 5 to 9, and an MCS endoscopic score >=2, rectal bleeding >=1, and stool frequency >=1, c.\thas had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids.\n- Female or male subjects from 8 to <18 years of age, on the date of signing the ICF."}

Exclusion criteria

  • {"criterion_text":"- Subject has a diagnosis of inflammatory bowel disease (IBD)-unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon\n- Subject has a history of colectomy or extensive small bowel resection.\n- Subject with psychological or cognitive difficulties that might interfere with study participation.\n- Subject has any previous exposure to a Janus kinase (JAK) inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib).\n- Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.\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).\n- Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS) at Week 10","definition_or_measurement_approach":"Clinical remission assessed by modified Mayo Clinical Score (mMCS) at Week 10."}
  • {"endpoint_text":"- Proportion of subjects achieving clinical remission based on mMCS2 at Week 58","definition_or_measurement_approach":"Clinical remission assessed by mMCS2 at Week 58."}

Secondary endpoints

  • {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs), adverse events of interest, and laboratory abnormalities through follow-up (Week 62)","definition_or_measurement_approach":"Incidence of TEAEs, specified adverse events of interest and lab abnormalities up to follow-up at Week 62."}
  • {"endpoint_text":"- Change from baseline in body mass index (BMI) at Week 58","definition_or_measurement_approach":"Change from baseline BMI measured at Week 58."}
  • {"endpoint_text":"- Change from baseline in height velocity at Week 58","definition_or_measurement_approach":"Change from baseline in height velocity measured at Week 58."}
  • {"endpoint_text":"- Proportion of subjects achieving clinical remission defined by Pediatric Ulcerative Colitis Activity Index (PUCAI) <10 at Week 10","definition_or_measurement_approach":"Proportion meeting PUCAI <10 at Week 10."}
  • {"endpoint_text":"- Proportion of subjects achieving clinical remission defined by PUCAI <10 at Week 58","definition_or_measurement_approach":"Proportion meeting PUCAI <10 at Week 58."}
  • {"endpoint_text":"- Proportion of subjects achieving endoscopic remission defined by Mayo endoscopic subscore of 0 at Week 10","definition_or_measurement_approach":"Endoscopic remission defined by Mayo endoscopic subscore = 0 at Week 10."}
  • {"endpoint_text":"- Proportion of subjects achieving endoscopic remission defined by Mayo endoscopic subscore of 0 at Week 58","definition_or_measurement_approach":"Endoscopic remission defined by Mayo endoscopic subscore = 0 at Week 58."}
  • {"endpoint_text":"- Proportion of subjects achieving mMCS response defined as mMCS reduction by >=2 points and >=30% from induction baseline, with decrease in rectal bleeding subscore of >=1 or absolute rectal bleeding subscore of 0 or 1 at Week 10","definition_or_measurement_approach":"mMCS response defined as >=2 point and >=30% reduction from induction baseline plus rectal bleeding subscore decrease >=1 or absolute rectal bleeding subscore 0 or 1 at Week 10."}
  • {"endpoint_text":"- Proportion of subjects achieving MCS response defined as mMCS reduction by >=2 points and >=30% from induction baseline, with decrease in rectal bleeding subscore of >=1 or absolute rectal bleeding subscore of 0 or 1 at Week 58","definition_or_measurement_approach":"mMCS response defined as >=2 point and >=30% reduction from induction baseline plus rectal bleeding subscore decrease >=1 or absolute rectal bleeding subscore 0 or 1 at Week 58."}
  • {"endpoint_text":"- Proportion of subjects achieving 6-month corticosteroid-free mMCS remission at Week 58","definition_or_measurement_approach":"Proportion achieving mMCS remission without corticosteroids for 6 months at Week 58."}
  • {"endpoint_text":"- Change from baseline in TUMMY-UC score at Week 10 and Week 58","definition_or_measurement_approach":"Change from baseline in TUMMY-UC patient-reported score at Weeks 10 and 58."}
  • {"endpoint_text":"- Proportion of subjects with TUMMY-UC remission at Week 10 and Week 58","definition_or_measurement_approach":"Proportion meeting TUMMY-UC remission at Weeks 10 and 58."}
  • {"endpoint_text":"- Change from baseline in IMPACT-III score at Week 10 and Week 58","definition_or_measurement_approach":"Change from baseline in IMPACT-III quality-of-life score at Weeks 10 and 58."}
  • {"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 parameters for filgotinib and GS-829845 including Cmax,ss, AUC0-24,ss and AUCeff,ss."}
  • {"endpoint_text":"- Acceptability of the age-appropriate pediatric film-coated tablet formulation assessed by Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P)","definition_or_measurement_approach":"Acceptability assessed using POMAQ-P for pediatric formulation."}
  • {"endpoint_text":"- Acceptability of the adult tablet formulation assessed by POMAQ-P","definition_or_measurement_approach":"Acceptability assessed using POMAQ-P for adult tablet formulation."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
68
Recruitment Window Months
43
Consent Approach
Parental/guardian informed consent is required for paediatric participants; age-appropriate assent documents are used (assent for non-readers, early readers, young adult readers). Dedicated parental ICFs and adolescent/participant-facing information sheets are provided. eConsent is supported (custom videos, invite/update emails, product description and security/data custody information). Specific materials are provided for adolescent pregnancy and for participants turning 18. Documents are available in multiple languages across country-specific submissions.

Methods

  • Recruitment materials for patients/adolescents: Adolescent Brochure, Parent/Guardian Brochure, Patient Poster (site-facing recruitment materials) to be distributed at sites and to families.
  • Clinician channel: 'Dr to Parent-Guardian' letters provided for investigators/clinicians to invite eligible patients.
  • Digital/eConsent channel: eConsent participation invitation emails, custom eConsent videos, trial introduction videos and on-screen eConsent materials to invite and consent participants remotely.
  • Site materials and supportive guides: Participant ID cards, study guides, parent study guides, visit reminder cards and study medication instruction cards available for sites to support retention and recruitment.

Geography

Total Number Of Sites
43
Total Number Of Participants
68

Ireland

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
375
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Children's Health Ireland
Department Name
Paediatric Gastroenterolgy
Principal Investigator Name
Seamus Hussey
Principal Investigator Email
seamus.hussey@olchc.ie
Contact Person Name
Seamus Hussey
Contact Person Email
seamus.hussey@olchc.ie

Belgium

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
375
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
gastroenterology
Principal Investigator Name
Patrick Bontems
Principal Investigator Email
patrick.bontems@huderf.be
Contact Person Name
Patrick Bontems
Contact Person Email
patrick.bontems@huderf.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
gastro-entérologie, hépatologie et nutrition pédiatrique
Principal Investigator Name
Marie Leonard
Principal Investigator Email
marie.leonard@citadelle.be
Contact Person Name
Marie Leonard
Contact Person Email
marie.leonard@citadelle.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Pédiatrie générale, Gastro-entérologie pédiatrique
Principal Investigator Name
Sabine Jespers
Principal Investigator Email
sabine.jespers@chuuclnamur.uclouvain.be
Contact Person Name
Sabine Jespers

Romania

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
462
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara
Department Name
Pediatrie III
Principal Investigator Name
Oana Belei
Principal Investigator Email
oana22_99@yahoo.com
Contact Person Name
Oana Belei
Contact Person Email
oana22_99@yahoo.com
Site Name
Dr. Victor Gomoiu Clinical Children Hospital
Department Name
Pediatrie 2
Principal Investigator Name
Iulia Florentina Tincu
Principal Investigator Email
if_boian@yahoo.com
Contact Person Name
Iulia Florentina Tincu
Contact Person Email
if_boian@yahoo.com

Poland

Earliest CTIS Part Ii Submission Date
29-10-2024
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
374
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Gabinet Lekarski Bartosz Korczowski
Principal Investigator Name
Bartosz Korczowski
Principal Investigator Email
korczowski@op.pl
Contact Person Name
Bartosz Korczowski
Contact Person Email
korczowski@op.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Gastroenterologii, Alergologii i Pediatrii
Principal Investigator Name
Elżbieta Czkwianianc
Principal Investigator Email
elzbieta.czkwianianc@iczmp.edu.pl
Contact Person Name
Elżbieta Czkwianianc
Site Name
In Vivo Sp. z o.o.
Principal Investigator Name
Piotr Korbal
Principal Investigator Email
kontakt@in-vivo.pl
Contact Person Name
Piotr Korbal
Contact Person Email
kontakt@in-vivo.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Szpital im. M. Kopernika, Kliniczny Oddział Gastroenterologii, Alergologii i Żywienia Dzieci GUMed
Principal Investigator Name
Michał Brzeziński
Principal Investigator Email
mbrzezinski@copernicus.gda.pl
Contact Person Name
Michał Brzeziński
Contact Person Email
mbrzezinski@copernicus.gda.pl
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Gastroenterologii, Hepatologii, Zaburzeń odżywiania i Pediatrii
Principal Investigator Name
Jarosław Kierkuś
Principal Investigator Email
j.kierkus@wip.waw.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@wip.waw.pl

Norway

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
374
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Sykehuset I Vestfold HF
Department Name
Pediatric
Principal Investigator Name
Johannes Rolin
Principal Investigator Email
rolijo@siv.no
Contact Person Name
Johannes Rolin
Contact Person Email
rolijo@siv.no
Site Name
Oslo University Hospital HF
Department Name
Pediatric
Principal Investigator Name
Gori Perminow
Principal Investigator Email
goeper@ous-hf.no
Contact Person Name
Gori Perminow
Contact Person Email
goeper@ous-hf.no

Spain

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
05-11-2025
Processing Time Days
376
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Hospital Germans Trias I Pujol
Department Name
Pediatría
Principal Investigator Name
Alba Alcaraz Hurtado
Principal Investigator Email
aalcaraz.germanstrias@gencat.cat
Contact Person Name
Alba Alcaraz Hurtado
Site Name
Hospital Universitario Reina Sofia
Department Name
Pediatría
Principal Investigator Name
Rafael González de Caldas
Principal Investigator Email
rgonzalezdecaldasmarchal@gmail.com
Contact Person Name
Rafael González de Caldas

Germany

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
377
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Kinder- und Jugendmedizin, Abt. I
Principal Investigator Name
Johannes Hilberath
Principal Investigator Email
johannes.hilberath@med.uni-tuebingen.de
Contact Person Name
Johannes Hilberath
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Zentrum für Kinder- und Jugendmedizin
Principal Investigator Name
Stephan Gehring
Principal Investigator Email
stephan.gehring@uni-mainz.de
Contact Person Name
Stephan Gehring
Contact Person Email
stephan.gehring@uni-mainz.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Kinder- und Jugendmedizin
Principal Investigator Name
Tobias Wenzl
Principal Investigator Email
twenzl@ukaachen.de
Contact Person Name
Tobias Wenzl
Contact Person Email
twenzl@ukaachen.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Kinder- und Jugendmedizin
Principal Investigator Name
Gunter Flemming
Principal Investigator Email
gunter.flemming@medizin.uni-leipzig.de
Contact Person Name
Gunter Flemming

Croatia

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
381
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Children's Hospital Zagreb
Department Name
Pediatric
Principal Investigator Name
Iva Hojsak
Principal Investigator Email
ivahojsak@gmail.com
Contact Person Name
Iva Hojsak
Contact Person Email
ivahojsak@gmail.com
Site Name
University Hospital Centre Zagreb
Department Name
Pediatric
Principal Investigator Name
Irena Senečić Čala
Principal Investigator Email
isenecic@yahoo.com
Contact Person Name
Irena Senečić Čala
Contact Person Email
isenecic@yahoo.com
Site Name
Klinicki Bolnicki Centar Osijek
Department Name
Pediatric
Principal Investigator Name
Vlatka Konjik
Principal Investigator Email
vlatkajurkovic@yahoo.com
Contact Person Name
Vlatka Konjik
Contact Person Email
vlatkajurkovic@yahoo.com

Portugal

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
380
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Juliana Roda
Principal Investigator Email
juroda@ulscoimbra.min-saude.pt
Contact Person Name
Juliana Roda
Contact Person Email
juroda@ulscoimbra.min-saude.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Pediatric
Principal Investigator Name
Henedina Antunes
Principal Investigator Email
henedina.antunes@hb.min-saude.pt
Contact Person Name
Henedina Antunes
Site Name
Unidade Local De Saude Do Alto Minho E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Isabel Martinho
Principal Investigator Email
isabel.martinho@ulsam.min-saude.pt
Contact Person Name
Isabel Martinho

Italy

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
550
Number Of Sites
7
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Department Name
Pediatric Unit
Principal Investigator Name
Enrico Felici
Principal Investigator Email
enrico.felici@ospedale.al.it
Contact Person Name
Enrico Felici
Contact Person Email
enrico.felici@ospedale.al.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Department of Paediatrics – Gastroenterology and Nutrition
Principal Investigator Name
Lorenzo Norsa
Principal Investigator Email
lorenzo.norsa@asst-fbf-sacco.it
Contact Person Name
Lorenzo Norsa
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Department of Translation al Medical Science, Section of Pediatrics
Principal Investigator Name
Erasmo Miele
Principal Investigator Email
erasmo.miele@unina.it
Contact Person Name
Erasmo Miele
Contact Person Email
erasmo.miele@unina.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Hepatogastroenterology and Nutrition
Principal Investigator Name
Daniela Knafelz
Principal Investigator Email
aniela.knafelz@opbg.net
Contact Person Name
Daniela Knafelz
Contact Person Email
aniela.knafelz@opbg.net
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
U.O.C. Pediatric Gastroenterology
Principal Investigator Name
Salvatore Oliva
Principal Investigator Email
salvatore.oliva@uniroma1.it
Contact Person Name
Salvatore Oliva
Contact Person Email
salvatore.oliva@uniroma1.it
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Pediatric Digestive Endoscopy and Nutrition Unit
Principal Investigator Name
Matteo Bramuzzo
Principal Investigator Email
matteo.bramuzzo@burlo.trieste.it
Contact Person Name
Matteo Bramuzzo
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department Name
DISCO
Principal Investigator Name
Simona Gatti
Principal Investigator Email
s.gatti@staff.univpm.it
Contact Person Name
Simona Gatti
Contact Person Email
s.gatti@staff.univpm.it

France

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
536
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service d'hépato-gastoentérologie et de nutrition pédiatrique
Principal Investigator Name
Laure Bridoux-Henno
Principal Investigator Email
laure.bridoux-henno@chu-rennes.fr
Contact Person Name
Laure Bridoux-Henno
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service de pédiatrie
Principal Investigator Name
Stéphanie Willot
Principal Investigator Email
s.willot@chu-tours.fr
Contact Person Name
Stéphanie Willot
Contact Person Email
s.willot@chu-tours.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Service de pédiatrie médicale et urgences pédiatriques
Principal Investigator Name
Ahlem Bouazza
Principal Investigator Email
bouazza.ahlem@ghicl.net
Contact Person Name
Ahlem Bouazza
Contact Person Email
bouazza.ahlem@ghicl.net
Site Name
CHU de Montpellier
Department Name
Service d'Hépatologie gastroentérologie et nutrition pédiatrique
Principal Investigator Name
Grégoire Lavaud
Principal Investigator Email
Gregoire.lavaud@chu-montpellier.fr
Contact Person Name
Grégoire Lavaud
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service de pédiatrie
Principal Investigator Name
Raphaëlle Maudinas
Principal Investigator Email
raphaelle.maudinas@chu-dijon.fr
Contact Person Name
Raphaëlle Maudinas
Site Name
Hospital Femme Mere Enfant
Department Name
Service de gastroentérologie, hépatologie et nutrition pédiatriques
Principal Investigator Name
Remi Duclaux-Loras
Principal Investigator Email
remi.duclaux-loras@chu-lyon.fr
Contact Person Name
Remi Duclaux-Loras
Contact Person Email
remi.duclaux-loras@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Rennes (additional listed site)
Department Name
Service d'hépato-gastoentérologie et de nutrition pédiatrique
Principal Investigator Name
Laure Bridoux-Henno
Principal Investigator Email
laure.bridoux-henno@chu-rennes.fr
Contact Person Name
Laure Bridoux-Henno

Greece

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
611
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Hippokration Hospital
Department Name
3rd Pediatric Department
Principal Investigator Name
Ioannis Xinias
Principal Investigator Email
xinias@email.com
Contact Person Name
Ioannis Xinias
Contact Person Email
xinias@email.com
Site Name
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Department Name
Second Department Pediatrics
Principal Investigator Name
Ioanna Argyri
Principal Investigator Email
ioarg@yahoo.gr
Contact Person Name
Ioanna Argyri
Contact Person Email
ioarg@yahoo.gr
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
4th Department of Pediatrics
Principal Investigator Name
Maria Fotoulaki
Principal Investigator Email
mfotoul@otenet.gr
Contact Person Name
Maria Fotoulaki
Contact Person Email
mfotoul@otenet.gr
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
3rd Department of Pediatrics
Principal Investigator Name
Smaragdi Fessatou
Principal Investigator Email
sfessatou@gmail.com
Contact Person Name
Smaragdi Fessatou
Contact Person Email
sfessatou@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
CRO
Name
Iqvia Biotech Limited
Responsibilities
CRO

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Endoscopy","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC (eConsent)","duties_or_roles":"eConsent","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Jyseleca 100 mg film-coated tablets
Active Substance
Filgotinib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation (EU/1/20/1480/001) indicated in product record
Investigational Product Name
Jyseleca 200 mg film-coated tablets
Active Substance
Filgotinib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation (EU/1/20/1480/003) indicated in product record
Investigational Product Name
GLPG0634
Active Substance
Filgotinib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Not marketed product record (sponsor product code GLPG0634)

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