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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT05995353

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Risankizumab (Drug)
    Intravenous (IV) Infusion
  • Risankizumab (Drug)
    Subcutaneous (SC) Injection

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.

Conditions

Crohn's Disease

Locations

  • Phoenix Children's Hospital /ID# 255766 — Phoenix, Arizona, United States
  • Arkansas Children's Hospital /ID# 255762 — Little Rock, Arkansas, United States
  • UCSF Benioff Children's Hospital - Oakland /ID# 258327 — Oakland, California, United States
  • Children's Hospital Colorado - Aurora /ID# 255764 — Aurora, Colorado, United States
  • Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437 — Orlando, Florida, United States
  • Indiana University Health Riley Hospital for Children /ID# 256454 — Indianapolis, Indiana, United States
  • Massachusetts General Hospital - Mass General Waltham /ID# 255767 — Waltham, Massachusetts, United States
  • MNGI Digestive Health, P. A. /ID# 255366 — Minneapolis, Minnesota, United States
  • Goryeb Childrens Hospital /ID# 256452 — Morristown, New Jersey, United States
  • Icahn School of Medicine at Mount Sinai /ID# 254880 — New York, New York, United States
  • Cleveland Clinic - Cleveland /ID# 256453 — Cleveland, Ohio, United States
  • Uza /Id# 255114 — Edegem, Antwerpen, Belgium
  • Cliniques Universitaires UCL Saint-Luc /ID# 255108 — Brussels, Brussels Capital, Belgium
  • Universitair Ziekenhuis Brussel /ID# 255109 — Jette, Brussels Capital, Belgium
  • Universitair Ziekenhuis Leuven /ID# 255098 — Leuven, Vlaams-Brabant, Belgium
  • Hospital Universite Enfants Reine Fabiola /ID# 255112 — Brussels, Belgium
  • Groupe Sante CHC - Clinique du MontLegia /ID# 255620 — Liège, Belgium
  • UMHAT Sveti Georgi EAD /ID# 255386 — Plovdiv, Bulgaria
  • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384 — Sofia, Bulgaria
  • UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358 — Varna, Bulgaria
  • Alberta Children's Hospital /ID# 255357 — Calgary, Alberta, Canada
  • Edmonton Clinic Health Academy /ID# 255361 — Edmonton, Alberta, Canada
  • BC Children's Hospital /ID# 255359 — Vancouver, British Columbia, Canada
  • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598 — London, Ontario, Canada
  • Beijing Children's Hospital /ID# 256081 — Beijing, Beijing Municipality, China
  • Peking University Third Hospital /ID# 255876 — Beijing, Beijing Municipality, China
  • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428 — Guangzhou, Guangdong, China
  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589 — Guangzhou, Guangdong, China
  • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562 — Zhengzhou, Henan, China
  • Hunan Children's Hospital /ID# 255610 — Changsha, Hunan, China
  • Jiangxi Provincial Children's Hospital /ID# 255564 — Nanchang, Jiangxi, China
  • Shengjing Hospital of China Medical University /ID# 255563 — Shenyang, Liaoning, China
  • Children's Hospital of Shanghai /ID# 255531 — Shanghai, Shanghai Municipality, China
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688 — Shanghai, Shanghai Municipality, China
  • Vseobecna Fakultni nemocnice v Praze /ID# 256096 — Prague, Praha 17, Czechia
  • Fakultni nemocnice Motol a Homolka /ID# 256547 — Prague, Praha 5, Czechia
  • CHRU Tours - Hopital Gatien de Clocheville /ID# 255052 — Tours, Centre-Val de Loire, France
  • Chu Bordeaux - Hopital Pellegrin /ID# 257060 — Bordeaux, New Aquitaine, France
  • CHU Toulouse - Hopital Paule de Viguier /ID# 255609 — Toulouse, Occitanie, France
  • Hospices Civils de Lyon - Hopital Femme Mere Enfant /ID# 255443 — Bron, Rhone, France
  • AP-HP - Hopital Necker /ID# 255608 — Paris, France
  • Dr. von Haunerschen Kinderspital /ID# 255577 — Munich, Bavaria, Germany
  • Universitaetsklinikum Muenster /ID# 256762 — Münster, North Rhine-Westphalia, Germany
  • Schneider Children's Medical Center /ID# 254950 — Petah Tikva, Central District, Israel
  • Shaare Zedek Medical Center /ID# 254951 — Jerusalem, Jerusalem, Israel
  • IRCCS Istituto Giannina Gaslini /ID# 255262 — Genoa, Genova, Italy
  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 255045 — Naples, Napoli, Italy
  • Ospedale Pediatrico Bambino Gesu /ID# 255043 — Rome, Roma, Italy
  • Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044 — Messina, Italy
  • Aichi Children's Health And Medical Center /ID# 272085 — Ōbu, Aichi-ken, Japan
  • Tsujinaka Hospital - Kashiwanoha /ID# 268409 — Kashiwa-shi, Chiba, Japan
  • Kurume University Hospital /ID# 268418 — Kurume-shi, Fukuoka, Japan
  • Gunma University Hospital /ID# 270560 — Maebashi, Gunma, Japan
  • Japanese Red Cross Kumamoto Hospital /ID# 268586 — Kumamoto, Kumamoto, Japan
  • Osaka Women's and Children's Hospital /ID# 268419 — Izumi-Shi, Osaka, Japan
  • Saitama Children's Medical Center /ID# 268410 — Saitama-shi, Saitama, Japan
  • Institute of Science Tokyo Hospital /ID# 269175 — Bunkyo-ku, Tokyo, Japan
  • Tokyo Metropolitan Children's Medical Center /ID# 268415 — Fuchu-shi, Tokyo, Japan
  • National Center For Child Health And Development /ID# 268420 — Setagaya City, Tokyo, Japan
  • Amsterdam University Medical Center /ID# 254827 — Amsterdam, North Holland, Netherlands
  • Gastromed Sp. z o.o /ID# 255939 — Torun, Kuyavian-Pomeranian Voivodeship, Poland
  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938 — Warsaw, Masovian Voivodeship, Poland
  • Puerto Rico Health Institute /ID# 255071 — Dorado, Puerto Rico
  • Clinical Research Puerto Rico /ID# 266479 — San Juan, Puerto Rico
  • Seoul National University Hospital /ID# 255318 — Seoul, Seoul Teugbyeolsi, South Korea
  • Yonsei University Health System - Severance Hospital /ID# 256976 — Seoul, Seoul Teugbyeolsi, South Korea
  • Samsung Medical Center /ID# 255284 — Seoul, Seoul Teugbyeolsi, South Korea
  • Kyungpook National University Chilgok Hospital /ID# 255817 — Daegu, South Korea
  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614 — Ferrol, A Coruna, Spain
  • Hospital Infantil Universitario Nino Jesus /ID# 255012 — Madrid, Spain
  • Hospital Regional Universitario de Malaga /ID# 257553 — Málaga, Spain
  • Sodersjukhuset /ID# 255239 — Stockholm, Stockholm County, Sweden
  • Astrid Lindgrens Barnsjukhus /ID# 255240 — Stockholm, Stockholm County, Sweden
  • Sahlgrenska Universitetssjukhuset /ID# 255236 — Gothenburg, Västra Götaland County, Sweden
  • Kinderspital Zurich - Eleonorenstiftung /ID# 255337 — Zurich, Canton of Zurich, Switzerland
  • Inselspital, Universitaetsspital Bern /ID# 255321 — Bern, Switzerland
  • Changhua Christian Hospital /ID# 256082 — Changhua City, Changhua County, Taiwan
  • National Taiwan University Hospital /ID# 255679 — Taipei, Taiwan
  • Gazi University Medical Faculty /ID# 255086 — Ankara, Turkey (Türkiye)
  • Sariyer Hamidiye Etfal Egitim Ve Araştirma Hastanesi /ID# 257143 — Istanbul, Turkey (Türkiye)
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020 — Istanbul, Turkey (Türkiye)
  • Kocaeli University Med Faculty /ID# 256922 — Kocaeli, Turkey (Türkiye)
  • Sheffield Children's Hospital NHS Foundation Trust /ID# 255758 — Sheffield, England, United Kingdom
  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757 — London, Greater London, United Kingdom
  • Birmingham Women's and Children's NHS Foundation Trust /ID# 255759 — Birmingham, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record