Clinical trial • Phase III • Gastroenterology

UPADACITINIB for Crohn's disease

Phase III trial of UPADACITINIB for Crohn's disease.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
12-04-2024
First CTIS Authorization Date
05-08-2024

Trial design

Randomised, open-label, external placebo (randomized double-blind maintenance comparator); active treatment: upadacitinib (at least the 30 mg adult equivalent dose stated in objectives).-controlled Phase III trial in Greece, Belgium, Bulgaria and others.

Randomised
Yes
Open Label
Yes
Comparator
External placebo (randomized double-blind maintenance comparator); active treatment: Upadacitinib (at least the 30 mg adult equivalent dose stated in objectives).
Target Sample Size
98
Trial Duration For Participant
448

Eligibility

Recruits 98 paediatric patients.

Vulnerable Population
Paediatric participants: age-specific assent and parental/legal guardian consent procedures are provided. Multiple assent forms and parental/legal representative informed consent forms are available by age group (documents list assent/ICF for ages including 2-5 years, 6-9, 10-11, 12-17, 13-15, 16-17 and parental/legal guardian forms). Country-specific ICF and assent documents are provided (examples in English, French, Dutch, Greek, Bulgarian, Polish, Italian, Spanish). Optional substudy consent/assent documents and pregnancy-specific ICFs are available where applicable.

Inclusion criteria

  • {"criterion_text":"- Weight at Screening and Baseline must be ≥ 10 kg\n- Moderate to severe CD defined as PCDAI > 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of >/ 6 (or SES-CD of >/4 for isolated ileal disease) excluding the presence of narrowing component.\n- Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available\n- Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, IMMs, and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US, participants must have demonstrated an inadequate response, loss or response, or intolerance to one or more anti-TNFs (tumor necrosis factor)."}

Exclusion criteria

  • {"criterion_text":"- History of: A diagnosis of CD prior to 2 years of age.\n- Currently known complications of CD such as: Active abscess (abdominal or perianal);\n- Currently known complications of CD such as: Symptomatic bowel strictures\n- Currently known complications of CD such as: More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum\n- Currently known complications of CD such as: Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections.\n- History of Fulminant colitis or toxic megacolon\n- History of Gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and/ or intussusception (telescoping of bowels)\n- Current diagnosis of any primary immune deficiency\n- Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Achievement of clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) in the participants who achieved clinical response per PCDAI at Week 12","definition_or_measurement_approach":"Clinical remission assessed using the Pediatric Crohn's Disease Activity Index (PCDAI) in participants who achieved clinical response at Week 12."}
  • {"endpoint_text":"- Achievement of endoscopic response in participants who achieved clinical response per PCDAI at Week 12.","definition_or_measurement_approach":"Endoscopic response assessed by endoscopic evaluation (centrally read endoscopy / SES-CD referenced elsewhere for endoscopic assessment)."}
  • {"endpoint_text":"- Number of Participants with Adverse Events","definition_or_measurement_approach":"Count of participants experiencing adverse events (safety reporting)."}

Secondary endpoints

  • {"endpoint_text":"- Achievement of clinical remission per PCDAI at week 12","definition_or_measurement_approach":"Clinical remission assessed by PCDAI at Week 12."}
  • {"endpoint_text":"- Achievement of endoscopic response at week 12","definition_or_measurement_approach":"Endoscopic response assessed by endoscopic evaluation at Week 12."}
  • {"endpoint_text":"- Achievement of endoscopic remission at week 12","definition_or_measurement_approach":"Endoscopic remission assessed by endoscopy at Week 12."}
  • {"endpoint_text":"- Achievement of clinical response per PCDAI at week 12","definition_or_measurement_approach":"Clinical response assessed by PCDAI at Week 12."}
  • {"endpoint_text":"- Achievement of clinical response per PCDAI at week 64 in participants who achieved clinical response per PCDAI at Week 12","definition_or_measurement_approach":"Clinical response assessed by PCDAI at Week 64 in the subgroup who had clinical response at Week 12."}
  • {"endpoint_text":"- Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12","definition_or_measurement_approach":"Endoscopic remission assessed by endoscopy at Week 64 in participants who had clinical response at Week 12."}
  • {"endpoint_text":"- Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12","definition_or_measurement_approach":"Clinical remission per PCDAI at Week 64 with absence of corticosteroid use (CS-free) in participants who had clinical response at Week 12."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
98
Recruitment Window Months
123
Consent Approach
Informed consent obtained from parent(s)/legal guardian(s); assent obtained from paediatric participants using age-appropriate assent forms. Multiple age-specific assent/ICF documents are provided (examples: 2-5 years, 6-9 years, 10-11, 12-17, 13-15, 16-17). Country- and language-specific ICFs and assent forms are provided (documents present in English, French, Dutch, Greek, Bulgarian, Polish, Italian, Spanish as per document list). Optional substudy consent materials and pregnancy-specific ICFs are available where applicable.

Methods

  • Country-specific recruitment materials and procedures documented ("Recruitment and ICF Procedures" documents).
  • Healthcare professional referral letters (e.g., doctor-to-parent/guardian letters, general practitioner letters).
  • Printed materials: parent-guardian flyers, posters, brochures distributed in participating sites.
  • Pre-consent animated videos / storyboards and other pre-consent multimedia to inform families prior to consent.
  • Site-based recruitment via participating hospitals/clinics (pediatric gastroenterology and related departments).

Geography

Total Number Of Sites
25
Total Number Of Participants
39

Greece

Earliest CTIS Part Ii Submission Date
10-07-2024
Latest Decision Or Authorization Date
15-09-2025
Processing Time Days
432
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Gastroenterology Department
Principal Investigator Name
Ioannis Koutroubakis
Principal Investigator Email
ikoutroub2@gmail.com
Contact Person Name
Ioannis Koutroubakis
Contact Person Email
ikoutroub2@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Gastroenterology Department
Principal Investigator Name
Georgios Bamias
Principal Investigator Email
gbamias@gmail.com
Contact Person Name
Georgios Bamias
Contact Person Email
gbamias@gmail.com
Site Name
Nosokomeio Paidon I Agia Sofia
Department Name
Gastroenterology Department
Principal Investigator Name
Alexandra Papadopoulou
Principal Investigator Email
alexandra.papadopoulou.office@gmail.com
Contact Person Name
Alexandra Papadopoulou

Belgium

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
12-09-2025
Processing Time Days
423
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Gastro Enterology
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
Antwerp University Hospital
Department Name
Gastro Enterology
Principal Investigator Name
Nicolette Moes
Principal Investigator Email
Nicolette.moes@uza.be
Contact Person Name
Nicolette Moes
Contact Person Email
Nicolette.moes@uza.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Gastro Enterology
Principal Investigator Name
Isabelle Scheers
Principal Investigator Email
isabelle.scheers@saintluc.uclouvain.be
Contact Person Name
Isabelle Scheers
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Gastro Enterology
Principal Investigator Name
Sabine Jespers
Principal Investigator Email
isabelle.jespers@chuuclnamur.uclouvain.be
Contact Person Name
Sabine Jespers
Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Gastro Enterology
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
UZ Leuven
Department Name
Gastro Enterology
Principal Investigator Name
Ilse Hoffman
Principal Investigator Email
ilse.hoffman@uzleuven.be
Contact Person Name
Ilse Hoffman
Contact Person Email
ilse.hoffman@uzleuven.be

Bulgaria

Earliest CTIS Part Ii Submission Date
24-07-2024
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
419
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Pediatrics
Principal Investigator Name
Ivan Yankov
Principal Investigator Email
epediatrics@abv.bg
Contact Person Name
Ivan Yankov
Contact Person Email
epediatrics@abv.bg
Site Name
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev
Department Name
Clinic of Chidren Gastroenterology
Principal Investigator Name
Mila Baycheva
Principal Investigator Email
mila.baycheva@gmail.com
Contact Person Name
Mila Baycheva
Contact Person Email
mila.baycheva@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
18-07-2024
Latest Decision Or Authorization Date
17-09-2025
Processing Time Days
426
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Gastromed Sp. z o.o.
Principal Investigator Name
Ewa Hapyn
Principal Investigator Email
ehapyn@gmail.com
Contact Person Name
Ewa Hapyn
Contact Person Email
ehapyn@gmail.com
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@ipczd.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@ipczd.pl

Italy

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
440
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Pediatric Gastroenterology, Hepatology and Cystic Fibrosis Unit
Principal Investigator Name
Marina Aloi
Principal Investigator Email
marina.aloi@policlinico.mi.it
Contact Person Name
Marina Aloi
Contact Person Email
marina.aloi@policlinico.mi.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
UO Gastroenterologia pediatrica e unità di fibrosi cistica
Principal Investigator Name
Claudio Romano
Principal Investigator Email
romanoc@unime.it
Contact Person Name
Claudio Romano
Contact Person Email
romanoc@unime.it
Site Name
Bambino Gesu Childrens Hospital
Department Name
UO epatogastroenterologia e nutrizione
Principal Investigator Name
Fiammetta Bracci
Principal Investigator Email
fiammetta.bracci@opbg.net
Contact Person Name
Fiammetta Bracci
Contact Person Email
fiammetta.bracci@opbg.net
Site Name
Casa Sollievo Della Sofferenza
Department Name
U.O.S. Gastroenterologia ed Epatologia Pediatrica
Principal Investigator Name
Maria Rosa Pastore
Principal Investigator Email
m.pastore@operapadrepio.it
Contact Person Name
Maria Rosa Pastore
Contact Person Email
m.pastore@operapadrepio.it

Spain

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
438
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Servicio de Digestivo
Principal Investigator Name
Maria Teresa Arroyo Villarino
Principal Investigator Email
tarroyo.salud.aragon@gmail.com
Contact Person Name
Maria Teresa Arroyo Villarino
Contact Person Email
tarroyo.salud.aragon@gmail.com
Site Name
Sant Joan De Deu Barcelona Hospital
Department Name
Unitat de Recerca Clínica
Principal Investigator Name
Francisco Javier Martin de Carpi
Principal Investigator Email
javier.martinc@sjd.es
Contact Person Name
Francisco Javier Martin de Carpi
Contact Person Email
javier.martinc@sjd.es
Site Name
Area Sanitaria De Ferrol
Department Name
Servicio de Digestivo
Principal Investigator Name
Ana Echarri Piudo
Principal Investigator Email
ana.echarri.piudo@sergas.es
Contact Person Name
Ana Echarri Piudo
Contact Person Email
ana.echarri.piudo@sergas.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Gastroenterologia
Principal Investigator Name
Victor Manuel Navas Lopez
Principal Investigator Email
estudios.clinicos@ibima.eu
Contact Person Name
Victor Manuel Navas Lopez
Contact Person Email
estudios.clinicos@ibima.eu
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Seccion de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Principal Investigator Name
Alejandro Rodriguez Martinez
Contact Person Name
Alejandro Rodriguez Martinez

France

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
06-01-2026
Processing Time Days
544
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Pédiatrie
Principal Investigator Name
Claire DUPONT
Principal Investigator Email
dupont-c@chu-caen.fr
Contact Person Name
Claire DUPONT
Contact Person Email
dupont-c@chu-caen.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastro-entérologie pédiatrique et nutrition
Principal Investigator Name
Christine MARTINEZ-VINSON
Principal Investigator Email
christine.martinez-vinson@aphp.fr
Contact Person Name
Christine MARTINEZ-VINSON
Site Name
Hospices Civils De Lyon
Department Name
Gastro-entérologie pédiatrique
Principal Investigator Name
Nicolas CARON
Principal Investigator Email
nicolas.caron@chu-lyon.fr
Contact Person Name
Nicolas CARON
Contact Person Email
nicolas.caron@chu-lyon.fr

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
WCG Clinical Inc.
Responsibilities
Cardiac and Gastrointestinal Perforation Adjudication
Name
Iqvia Biotech Limited
Responsibilities
Code 2 (sponsor duties entry)
Name
Iqvia Biotech LLC
Responsibilities
Code 3 (sponsor duties entry)
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central laboratory functions (code 4)
Name
Cytel Inc.
Responsibilities
Independent Data Monitoring Committee
Name
Eresearchtechnology Inc.
Responsibilities
ePro & eDiaries
Name
Veeva Systems Inc.
Responsibilities
Code 7 (sponsor duties entry)
Name
Alimentiv Inc.
Responsibilities
Central Imaging

Third parties

  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Cardiac and Gastrointestinal Perforation Adjudication","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"2","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Independent Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePro & eDiaries","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Upadacitinib
Active Substance
UPADACITINIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (prodAuthStatus 1)

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