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A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease

NCT05995353 · AbbVie
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Official title
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
About this study
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. Approximately 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 criteria
Inclusion Criteria: * 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 Exclusion Criteria: * History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class * Any of the following medical disorders: 1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD. 2. A diagnosis of CD prior to 2 years of age. 3. A diagnosis or suspected diagnosis of a primary immunodeficiency. 4. Currently known complications of CD such as: * Active abscess (abdominal or perianal); * Symptomatic bowel strictures; * \> 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; * Fulminant colitis; * Toxic megacolon; * Or any other manifestation that might require surgery while enrolled in the study. 5. Ostomy or ileoanal pouch. 6. Diagnosis of short gut or short bowel syndrome. 7. Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of \>3 bowel resections.
Study design
Enrollment target: 110 participants
Allocation: randomized
Masking: quadruple
Age groups: child
Timeline
Starts: 2023-12-11
Estimated completion: 2029-04
Last updated: 2026-03-18
Interventions
Drug: RisankizumabDrug: Risankizumab
Primary outcomes
  • Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission (At 64 weeks)
  • Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD) (At 64 weeks)
  • Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab (Up to approximately Week 64)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (85)
Phoenix Children's Hospital /ID# 255766Recruiting
Phoenix, Arizona, United States
Arkansas Children's Hospital /ID# 255762Recruiting
Little Rock, Arkansas, United States
UCSF Benioff Children's Hospital - Oakland /ID# 258327Recruiting
Oakland, California, United States
Children's Hospital Colorado - Aurora /ID# 255764Recruiting
Aurora, Colorado, United States
Arnold Palmer Hospital for Children Center Digestive Health & Nutrition - Orland /ID# 255437Recruiting
Orlando, Florida, United States
Indiana University Health Riley Hospital for Children /ID# 256454Recruiting
Indianapolis, Indiana, United States
Massachusetts General Hospital /ID# 255767Recruiting
Boston, Massachusetts, United States
MNGI Digestive Health, P. A. /ID# 255366Recruiting
Minneapolis, Minnesota, United States
Goryeb Childrens Hospital /ID# 256452Recruiting
Morristown, New Jersey, United States
Icahn School of Medicine at Mount Sinai /ID# 254880Recruiting
New York, New York, United States
Cleveland Clinic - Cleveland /ID# 256453Recruiting
Cleveland, Ohio, United States
Uza /Id# 255114Recruiting
Edegem, Antwerpen, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 255108Recruiting
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel /ID# 255109Recruiting
Jette, Brussels Capital, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 255620Recruiting
Liège, Liege, Belgium
Universitair Ziekenhuis Leuven /ID# 255098Recruiting
Leuven, Vlaams-Brabant, Belgium
Hospital Universite Enfants Reine Fabiola /ID# 255112Recruiting
Brussels, Belgium
UMHAT Sveti Georgi /ID# 255386Recruiting
Plovdiv, Bulgaria
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384Recruiting
Sofia, Bulgaria
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358Recruiting
Varna, Bulgaria
Alberta Children's Hospital /ID# 255357Recruiting
Calgary, Alberta, Canada
Edmonton Clinic Health Academy /ID# 255361Recruiting
Edmonton, Alberta, Canada
BC Children's Hospital /ID# 255359Recruiting
Vancouver, British Columbia, Canada
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598Recruiting
London, Ontario, Canada
Beijing Children's Hospital /ID# 256081Recruiting
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 255876Recruiting
Beijing, Beijing Municipality, China
Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428Recruiting
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589Recruiting
Guangzhou, Guangdong, China
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562Recruiting
Zhengzhou, Henan, China
Hunan Children's Hospital /ID# 255610Recruiting
Changsha, Hunan, China
Jiangxi Provincial Children's Hospital /ID# 255564Recruiting
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University /ID# 255563Recruiting
Shenyang, Liaoning, China
Children's Hospital of Shanghai /ID# 255531Recruiting
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688Recruiting
Shanghai, Shanghai Municipality, China
Vseobecna Fakultni Nemocnice v Praze /ID# 256096Recruiting
Prague, Praha 17, Czechia
Fakultní nemocnice v Motole /ID# 256547Recruiting
Prague, Praha 5, Czechia
CHRU Tours - Hopital Gatien de Clocheville /ID# 255052Recruiting
Tours, Centre-Val de Loire, France
CHU Bordeaux - Hopital Pellegrin /ID# 257060Recruiting
Bordeaux, New Aquitaine, France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 255443Recruiting
Bron, Rhone, France
AP-HP - Hopital Necker /ID# 255608Recruiting
Paris, France
CHU Toulouse - Hopital Paule de Viguier /ID# 255609Recruiting
Toulouse, France
Dr. von Haunerschen Kinderspital /ID# 255577Recruiting
Munich, Bavaria, Germany
Universitaetsklinikum Muenster /ID# 256762Recruiting
Münster, North Rhine-Westphalia, Germany
Schneider Children's Medical Center /ID# 254950Recruiting
Petah Tikva, Central District, Israel
Shaare Zedek Medical Center /ID# 254951Recruiting
Jerusalem, Jerusalem, Israel
IRCCS Istituto Giannina Gaslini /ID# 255262Recruiting
Genoa, Genova, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 255045Recruiting
Naples, Napoli, Italy
Ospedale Pediatrico Bambino Gesù /ID# 255043Recruiting
Rome, Roma, Italy
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044Recruiting
Messina, Italy
Aichi Children'S Health And Medical Center /ID# 272085Recruiting
Ōbu, Aichi-ken, Japan
Tsujinaka Hospital - Kashiwanoha /ID# 268409Recruiting
Kashiwa-shi, Chiba, Japan
Kurume University Hospital /ID# 268418Recruiting
Kurume-shi, Fukuoka, Japan
Gunma University Hospital /ID# 270560Recruiting
Maebashi, Gunma, Japan
Japanese Red Cross Kumamoto Hospital /ID# 268586Recruiting
Kumamoto, Kumamoto, Japan
Osaka Women's and Children's Hospital /ID# 268419Recruiting
Izumi-Shi, Osaka, Japan
Saitama Children's Medical Center /ID# 268410Recruiting
Saitama-shi, Saitama, Japan
Institute of Science Tokyo Hospital /ID# 269175Recruiting
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Children's Medical Center /ID# 268415Recruiting
Fuchu-shi, Tokyo, Japan
National Center For Child Health And Development /ID# 268420Recruiting
Setagaya City, Tokyo, Japan
Amsterdam UMC, locatie AMC /ID# 254827Recruiting
Amsterdam, North Holland, Netherlands
Gastromed Sp. z o.o /ID# 255939Completed
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938Recruiting
Warsaw, Masovian Voivodeship, Poland
Puerto Rico Health Institute /ID# 255071Recruiting
Dorado, Puerto Rico
Clinical Research Puerto Rico /ID# 266479Recruiting
San Juan, Puerto Rico
Seoul National University Hospital /ID# 255318Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 256976Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 255284Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Kyungpook National University Chilgok Hospital /ID# 255817Recruiting
Daegu, South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614Recruiting
Ferrol, A Coruna, Spain
Hospital Infantil Universitario Nino Jesus /ID# 255012Recruiting
Madrid, Spain
Hospital Regional Universitario de Malaga /ID# 257553Recruiting
Málaga, Spain
Sodersjukhuset /ID# 255239Recruiting
Stockholm, Stockholm County, Sweden
Astrid Lindgrens Barnsjukhus /ID# 255240Recruiting
Stockholm, Stockholm County, Sweden
Sahlgrenska Universitetssjukhuset /ID# 255236Recruiting
Gothenburg, Västra Götaland County, Sweden
University Children's Hospital Zurich - Eleonorenstiftung /ID# 255337Recruiting
Zurich, Canton of Zurich, Switzerland
Inselspital, Universitaetsspital Bern /ID# 255321Recruiting
Bern, Switzerland
National Taiwan University Hospital /ID# 255679Recruiting
Taipei City, Taipei, Taiwan
Changhua Christian Hospital /ID# 256082Recruiting
Changhua City, Changhua County, Taiwan
Gazi University Medical Faculty /ID# 255086Recruiting
Ankara, Turkey (Türkiye)
Sariyer Hamidiye Etfal Eğitim Ve Araştirma Hastanesi /ID# 257143Recruiting
Istanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020Recruiting
Istanbul, Turkey (Türkiye)
Kocaeli University Med Faculty /ID# 256922Recruiting
Kocaeli, Turkey (Türkiye)
Sheffield Children's Hospital NHS Foundation Trust /ID# 255758Recruiting
Sheffield, England, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757Recruiting
London, Greater London, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust /ID# 255759Recruiting
Birmingham, United Kingdom
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease · TrialPath