Clinical trial • Phase III • Gastroenterology
RISANKIZUMAB for Ulcerative colitis
Phase III trial of RISANKIZUMAB for Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 08-05-2025
- First CTIS Authorization Date
- 29-08-2025
Trial design
Randomised, open-label, risankizumab placebo (placebo comparator); dose and schedule not specified in provided data-controlled Phase III trial in Belgium, Greece, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- risankizumab placebo (placebo comparator); dose and schedule not specified in provided data
- Target Sample Size
- 87
Eligibility
Recruits 87 paediatric patients.
- Vulnerable Population
- Pediatric subjects aged 2 to <18 years are included. The study uses age-appropriate assent and parent/guardian consent procedures: assent forms and ICFs are provided for age groups (titles indicate assent/ICF for ages 2-5, 6-11, 12-17) and parental/guardian consent forms are provided. Country- and language-specific ICF/assent documents are available (examples in the file list: English, Dutch, French for BE; German for DE; Italian for IT; Spanish for ES; Greek for GR; Swedish for SE). Consent is provided by parent/guardian with assent from the child as appropriate to age.
Inclusion criteria
- {"criterion_text":"- Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).\n- Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.\n- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available."}
Exclusion criteria
- {"criterion_text":"- Subjects who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).\n- Subjects who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- PK Lead-in Cohort 1 and Cohort 2: Maximum Observed Serum Concentration (Cmax)","definition_or_measurement_approach":"Measured by serum concentrations (pharmacokinetic assessment)."}
- {"endpoint_text":"- PK Lead-in Cohort 1 and Cohort 2: Time to Maximum Serum Concentration (Tmax)","definition_or_measurement_approach":"Measured by serum concentration-time profile to determine time to peak concentration."}
- {"endpoint_text":"- PK Lead-in Cohort 1 and Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)","definition_or_measurement_approach":"Calculated from serum concentration-time data over the dosing interval (AUCtau)."}
- {"endpoint_text":"- Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) at Week 64 Among Week 12 Clinical Responders per mMS","definition_or_measurement_approach":"Assessed using the Modified Mayo Score (mMS) to determine clinical remission at Week 64 among Week 12 responders."}
Secondary endpoints
- {"endpoint_text":"- PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical remission per mMS at Week 64 among Week 12 responders per mMS","definition_or_measurement_approach":"Assessed using the Modified Mayo Score (mMS) at Weeks 12 and 64."}
- {"endpoint_text":"- PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical remission per mMS at Week 12","definition_or_measurement_approach":"Assessed using the Modified Mayo Score (mMS) at Week 12."}
- {"endpoint_text":"- PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical response per mMS at Week 12","definition_or_measurement_approach":"Assessed using the Modified Mayo Score (mMS) to define clinical response at Week 12."}
- {"endpoint_text":"- PK Lead-In Cohort 1 and Cohort 2: Achievement of endoscopic improvement at Week 12","definition_or_measurement_approach":"Endoscopic assessment to evaluate improvement at Week 12."}
- {"endpoint_text":"- PK Lead-In Cohort 1 and Cohort 2: Symptomatic response per partial mMS at Week 12","definition_or_measurement_approach":"Assessed using the partial Modified Mayo Score (partial mMS) for symptomatic response at Week 12."}
- {"endpoint_text":"- PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical response per mMS at Week 64 among Week 12 responders per mMS","definition_or_measurement_approach":"Assessed using the Modified Mayo Score (mMS) at Weeks 12 and 64."}
- {"endpoint_text":"- PK Lead-In Cohort 1 and Cohort 2: Achievement of endoscopic improvement at Week 64 among Week 12 responders per mMS","definition_or_measurement_approach":"Endoscopic assessment at Week 64 among Week 12 responders."}
- {"endpoint_text":"- PK Lead-In Cohort 1 and Cohort 2: Ability to discontinue corticosteroids prior to Week 64 (at least 90 days without corticosteroid exposure) and achievement of clinical remission per mMS among Week 12 responders per mMS","definition_or_measurement_approach":"Defined as at least 90 days without corticosteroid exposure prior to Week 64 and assessment of clinical remission by mMS among Week 12 responders."}
- {"endpoint_text":"- Expansion Cohort 3: Achievement of clinical remission per mMS at Week 12","definition_or_measurement_approach":"Assessed using the Modified Mayo Score (mMS) at Week 12."}
- {"endpoint_text":"- Expansion Cohort 3: Achievement of clinical response per mMS at Week 12","definition_or_measurement_approach":"Assessed using the Modified Mayo Score (mMS) at Week 12."}
- {"endpoint_text":"- Expansion Cohort 3: Achievement of endoscopic improvement at Week 12","definition_or_measurement_approach":"Endoscopic assessment to evaluate improvement at Week 12."}
- {"endpoint_text":"- Expansion Cohort 3: Symptomatic response per partial mMS at Week 12","definition_or_measurement_approach":"Assessed using the partial Modified Mayo Score (partial mMS) for symptomatic response at Week 12."}
- {"endpoint_text":"- Expansion Cohort 3: Achievement of clinical response per mMS at Week 64 among Week 12 responders per mMS","definition_or_measurement_approach":"Assessed using the Modified Mayo Score (mMS) at Week 64 among Week 12 responders."}
- {"endpoint_text":"- Expansion Cohort 3: Achievement of endoscopic improvement at Week 64 among Week 12 responders per mMS","definition_or_measurement_approach":"Endoscopic assessment at Week 64 among Week 12 responders."}
- {"endpoint_text":"- Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS at Week 64 among Week 12 responders per mMS","definition_or_measurement_approach":"Corticosteroid-free remission assessed by mMS at Week 64 among Week 12 responders (corticosteroid-free defined as no corticosteroid exposure for the specified period in the protocol)."}
Recruitment
- Planned Sample Size
- 87
- Recruitment Window Months
- 106
- Consent Approach
- Informed consent is provided by parent(s)/legal guardian(s); assent is obtained from pediatric participants using age-appropriate assent forms. ICF and assent documents are prepared by country and age group (documents in the file list include assent/ICF for ages 2-5, 6-11, 12-17 and parental/guardian ICFs). Country/language-specific documents are available (examples include English, Dutch, French for Belgium; German for Germany; Italian for Italy; Spanish for Spain; Greek for Greece; Swedish for Sweden).
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 33
Belgium
- Earliest CTIS Part Ii Submission Date
- 06-08-2025
- Latest Decision Or Authorization Date
- 29-08-2025
- Processing Time Days
- 23
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
- Department Name
- Gastroenterology (Pediatric)
- 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
- Gastroenterology (Pediatric)
- Principal Investigator Name
- Emeline Bequet
- Principal Investigator Email
- emeline.bequet@chrcitadelle.be
- Contact Person Name
- Emeline Bequet
- Contact Person Email
- emeline.bequet@chrcitadelle.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Gastroenterology (Pediatric)
- Principal Investigator Name
- Isabelle Scheers
- Principal Investigator Email
- isabelle.scheers@saintluc.uclouvain.be
- Contact Person Name
- Isabelle Scheers
- Contact Person Email
- isabelle.scheers@saintluc.uclouvain.be
Greece
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 36
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 3rd University Internal Medicine department
- Principal Investigator Name
- Georgios Bamias
- Principal Investigator Email
- gastro.sotiria@gmail.com
- Contact Person Name
- Georgios Bamias
- Contact Person Email
- gastro.sotiria@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- Paediatric gastroenterology unit, Hepatology and Dietetics, 3rd University Paediatric Clinic
- Principal Investigator Name
- Smaragdi Fessatou
- Principal Investigator Email
- sfessatou@yahoo.gr
- Contact Person Name
- Smaragdi Fessatou
- Contact Person Email
- sfessatou@yahoo.gr
- Site Name
- Hippokration Hospital
- Department Name
- 3rd Pediatric
- Principal Investigator Name
- Ioannis Xinias
- Principal Investigator Email
- xinias@auth.gr
- Contact Person Name
- Ioannis Xinias
- Contact Person Email
- xinias@auth.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 07-08-2025
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 26
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Pediatrics
- Principal Investigator Name
- Annamaria Staiano
- Principal Investigator Email
- staiano@unina.it
- Contact Person Name
- Annamaria Staiano
- Contact Person Email
- staiano@unina.it
- Site Name
- Casa Sollievo Della Sofferenza
- Department Name
- Pediatric department
- 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
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Medicina Interna e Gastroenterologia
- Principal Investigator Name
- Antonio Gasbarrini
- Principal Investigator Email
- antonio.gasbarrini@unicatt.it
- Contact Person Name
- Antonio Gasbarrini
- Contact Person Email
- antonio.gasbarrini@unicatt.it
- Site Name
- Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
- Department Name
- Paediatric Gastroenterology
- Principal Investigator Name
- Matteo Bramuzzo
- Principal Investigator Email
- matteo.bramuzzo@burlo.trieste.it
- Contact Person Name
- Matteo Bramuzzo
- Contact Person Email
- matteo.bramuzzo@burlo.trieste.it
Spain
- Earliest CTIS Part Ii Submission Date
- 03-06-2025
- Latest Decision Or Authorization Date
- 03-09-2025
- Processing Time Days
- 92
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Pediatric Gastroenterology Unit
- Principal Investigator Name
- Carolina Gutierrez Junquera
- Principal Investigator Email
- carolina.gutijun@salud.madrid.org
- Contact Person Name
- Carolina Gutierrez Junquera
- Contact Person Email
- carolina.gutijun@salud.madrid.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Servicio de Pediatría
- Principal Investigator Name
- Ana Moreno Alvarez
- Principal Investigator Email
- Ana.Moreno.Alvarez@sergas.es
- Contact Person Name
- Ana Moreno Alvarez
- Contact Person Email
- Ana.Moreno.Alvarez@sergas.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 24
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
- Department Name
- Sektionen för Pediatrisk Gastroenterologi, Hepatologi och Nutrition
- Principal Investigator Name
- Robert Saalman
- Principal Investigator Email
- robert.saalman@vgregion.se
- Contact Person Name
- Robert Saalman
- Contact Person Email
- robert.saalman@vgregion.se
- Site Name
- Soedersjukhuset AB
- Department Name
- Sachsska Barn- och Ungdomssjukhuset
- Principal Investigator Name
- Petter Malmborg
- Principal Investigator Email
- petter.malmborg@regionstockholm.se
- Contact Person Name
- Petter Malmborg
- Contact Person Email
- petter.malmborg@regionstockholm.se
- Site Name
- Karolinska University Hospital
- Department Name
- Astrid Lindgren's Children Hospital
- Principal Investigator Name
- Henrik Arnell
- Principal Investigator Email
- henrik.arnell@regionstockholm.se
- Contact Person Name
- Henrik Arnell
- Contact Person Email
- henrik.arnell@regionstockholm.se
Germany
- Earliest CTIS Part Ii Submission Date
- 22-08-2025
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 161
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Medical University Of Lausitz Carl Thiem
- Principal Investigator Name
- Simone Stolz
- Principal Investigator Email
- m.loebel@mul-ct.de
- Contact Person Name
- Simone Stolz
- Contact Person Email
- m.loebel@mul-ct.de
- Site Name
- Klinikum Westbrandenburg GmbH
- Department Name
- Klinik für Gastroenterologie, Hepatologie, Infektiologie und Rheumatologie
- Principal Investigator Name
- Daniel Baumgart
- Principal Investigator Email
- daniel.baumgart@klinikumevb.de
- Contact Person Name
- Daniel Baumgart
- Contact Person Email
- daniel.baumgart@klinikumevb.de
- Site Name
- Klinikum Kassel GmbH
- Principal Investigator Name
- Ralph Melchior
- Principal Investigator Email
- ralph.melchior@gnh.net
- Contact Person Name
- Ralph Melchior
- Contact Person Email
- ralph.melchior@gnh.net
- Site Name
- Universitaetsklinikum Muenster AöR
- Principal Investigator Name
- Thomas Kaiser
- Principal Investigator Email
- Thomas.Kaiser@ukmuenster.de
- Contact Person Name
- Thomas Kaiser
- Contact Person Email
- Thomas.Kaiser@ukmuenster.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medizinische Klinik 4
- Principal Investigator Name
- André Hörning
- Principal Investigator Email
- gastroenterologie.kinder@uk-erlangen.de
- Contact Person Name
- André Hörning
- Contact Person Email
- gastroenterologie.kinder@uk-erlangen.de
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- sponsorDuties codes: 4
- Name
- Signant Health Management Limited
- Responsibilities
- sponsorDuties codes: 7
- Name
- Alimentiv Inc.
- Responsibilities
- Imaging (sponsorDuties id 15)
- Name
- WCG Clinical Inc.
- Responsibilities
- Data monitoring committee (sponsorDuties id 15)
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 3
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"sponsorDuties: 15 (Imaging)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties: 15 (Data monitoring committee)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Risankizumab
- Active Substance
- RISANKIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- ABBV-066 / Risankizumab
- Active Substance
- RISANKIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- ABBV-066
- Active Substance
- RISANKIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- risankizumab placebo
- Modality
- Other
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