A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 110 pediatric participants with CD will be enrolled at around 100 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• Pediatric individuals, 2 to \< 18 years old

• Must have moderately to severely active CD, as defined by the PCDAI score \> 30 assessed at Baseline

• Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)

• Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies

Locations
United States
Arkansas
Arkansas Children's Hospital /ID# 255762
RECRUITING
Little Rock
Arizona
Phoenix Children's Hospital /ID# 255766
RECRUITING
Phoenix
California
UCSF Benioff Children's Hospital - Oakland /ID# 258327
RECRUITING
Oakland
Colorado
Children's Hospital Colorado - Aurora /ID# 255764
RECRUITING
Aurora
Florida
Arnold Palmer Hospital for Children Center Digestive Health & Nutrition - Orland /ID# 255437
RECRUITING
Orlando
Indiana
Indiana University Health Riley Hospital for Children /ID# 256454
RECRUITING
Indianapolis
Massachusetts
Massachusetts General Hospital /ID# 255767
RECRUITING
Boston
Minnesota
MNGI Digestive Health, P. A. /ID# 255366
RECRUITING
Minneapolis
New Jersey
Goryeb Children's Hospital /ID# 256452
RECRUITING
Morristown
New York
Icahn School of Medicine at Mount Sinai /ID# 254880
RECRUITING
New York
Other Locations
Belgium
Hospital Universite Enfants Reine Fabiola /ID# 255112
RECRUITING
Bruxelles
Uza /Id# 255114
RECRUITING
Edegem
Universitair Ziekenhuis Brussel /ID# 255109
RECRUITING
Jette
Universitair Ziekenhuis Leuven /ID# 255098
RECRUITING
Leuven
Groupe Sante CHC - Clinique du MontLegia /ID# 255620
RECRUITING
Liege
Cliniques Universitaires UCL Saint-Luc /ID# 255108
RECRUITING
Woluwe-saint-lambert
Bulgaria
UMHAT Sveti Georgi /ID# 255386
RECRUITING
Plovdiv
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384
RECRUITING
Sofiya
UMHAT Sveta Marina /ID# 256358
RECRUITING
Varna
Canada
Alberta Children's Hospital /ID# 255357
RECRUITING
Calgary
London Health Sciences Center- University Hospital /ID# 258598
RECRUITING
London
China
Beijing Children's Hospital /ID# 256081
RECRUITING
Beijing
Peking University Third Hospital /ID# 255876
RECRUITING
Beijing
Hunan Children's Hospital /ID# 255610
RECRUITING
Changsha
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688
RECRUITING
Shanghai
France
CHU Bordeaux - Hopital Pellegrin /ID# 257060
RECRUITING
Bordeaux
HCL - Hopital Femme Mere Enfant /ID# 255443
RECRUITING
Bron Cedex
AP-HP - Hopital Necker /ID# 255608
RECRUITING
Paris
CHU Toulouse - Hopital Paule de Viguier /ID# 255609
RECRUITING
Toulouse
CHRU Tours - Hopital Gatien de Clocheville /ID# 255052
RECRUITING
Tours
Germany
Dr. von Haunerschen Kinderspital /ID# 255577
RECRUITING
Muenchen
Universitaetsklinikum Muenster /ID# 256762
RECRUITING
Muenster
Israel
Shaare Zedek Medical Center /ID# 254951
RECRUITING
Jerusalem
Schneider Children's Medical Center /ID# 254950
RECRUITING
Petah Tikva
Italy
IRCCS Istituto Giannina Gaslini /ID# 255262
RECRUITING
Genoa
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044
RECRUITING
Messina
Azienda Ospedaliera Universitaria Federico II /ID# 255045
RECRUITING
Naples
Netherlands
Amsterdam UMC, locatie AMC /ID# 254827
RECRUITING
Amsterdam
Poland
Gastromed Sp. z o.o /ID# 255939
RECRUITING
Torun
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938
RECRUITING
Warszawa
Puerto Rico
Puerto Rico Health Institute /ID# 255071
RECRUITING
Dorado
Clinical Research Puerto Rico /ID# 266479
RECRUITING
San Juan
Republic of Korea
Kyungpook National University Chilgok Hospital /ID# 255817
RECRUITING
Daegu
Samsung Medical Center /ID# 255284
RECRUITING
Seoul
Seoul National University Hospital /ID# 255318
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 256976
RECRUITING
Seoul
Spain
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614
RECRUITING
Ferrol
Hospital Infantil Universitario Nino Jesus /ID# 255012
RECRUITING
Madrid
Hospital Regional Universitario de Malaga /ID# 257553
RECRUITING
Malaga
Sweden
Sahlgrenska Universitetssjukhuset /ID# 255236
RECRUITING
Göteborg
Karolinska University Hospital Solna /ID# 255240
RECRUITING
Solna
Sodersjukhuset /ID# 255239
RECRUITING
Stockholm
Switzerland
Inselspital, Universitaetsspital Bern /ID# 255321
RECRUITING
Bern
Kinderspital Zurich - Eleonorenstiftung /ID# 255337
RECRUITING
Zurich
Taiwan
Changhua Christian Hospital /ID# 256082
RECRUITING
Changhua City, Changhua County
National Taiwan University Hospital /ID# 255679
RECRUITING
Taipei City
Turkey
Gazi University Medical Faculty /ID# 255086
RECRUITING
Ankara
Kocaeli University Med Faculty /ID# 256922
RECRUITING
Kocaeli
United Kingdom
Barts Health NHS Trust /ID# 255757
RECRUITING
London
Sheffield Children's Hospital NHS Foundation Trust /ID# 255758
RECRUITING
Sheffield
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2029-04
Participants
Target number of participants: 110
Treatments
Experimental: PK Cohort 1: SS1
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
Experimental: PK Cohort 1: SS2 Dose A
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Experimental: PK Cohort 1: SS2 Dose B
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Experimental: PK Cohort 1: SS3 Dose A
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Experimental: PK Cohort 1: SS3 Dose B
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Experimental: PK Cohort 2: SS1
Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
Experimental: PK Cohort 2: SS2 Dose A
Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Experimental: PK Cohort 2: SS2 Dose B
Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Experimental: PK Cohort 2: SS3 Dose A
Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Experimental: PK Cohort 2: SS3 Dose B
Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Experimental: Expansion Cohort 3: SS1
Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
Experimental: Expansion Cohort 3: SS2 Dose A
Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Experimental: Expansion Cohort 3: SS2 Dose B
Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Experimental: Expansion Cohort 3: SS3 Dose A
Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Experimental: Expansion Cohort 3: SS3 Dose B
Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov