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 (RISE)

May 27, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Recruiting
        • Hospital Universite Enfants Reine Fabiola /ID# 255112
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Uza /Id# 255114
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires UCL Saint-Luc /ID# 255108
      • Jette, Brussels Capital, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel /ID# 255109
    • Liege
      • Liège, Liege, Belgium, 4000
        • Recruiting
        • Groupe Sante CHC - Clinique du MontLegia /ID# 255620
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven /ID# 255098
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • UMHAT Sveti Georgi /ID# 255386
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384
      • Varna, Bulgaria, 9009
        • Recruiting
        • UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital /ID# 255357
      • Edmonton, Alberta, Canada, T6G 1C9
        • Recruiting
        • Edmonton Clinic Health Academy /ID# 255361
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • BC Children's Hospital /ID# 255359
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100045
        • Recruiting
        • Beijing Children's Hospital /ID# 256081
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital /ID# 255876
        • Contact:
          • Site Coordinator
          • Phone Number: +86 010-82266699
    • Guangdong
      • Guangzhou, Guangdong, China, 510620
        • Recruiting
        • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589
    • Henan
      • Zhengzhou, Henan, China, 450018
        • Recruiting
        • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562
    • Hunan
      • Changsha, Hunan, China, 410007
        • Recruiting
        • Hunan Children's Hospital /ID# 255610
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Jiangxi Provincial Children's Hospital /ID# 255564
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Recruiting
        • Shengjing Hospital of China Medical University /ID# 255563
        • Contact:
          • Site Coordinator
          • Phone Number: +86 024 96615
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200062
        • Recruiting
        • Children's Hospital of Shanghai /ID# 255531
      • Shanghai, Shanghai Municipality, China, 200065
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688
  • Czechia
    • Praha 17
      • Prague, Praha 17, Czechia, 128 00
        • Completed
        • Vseobecna Fakultni nemocnice v Praze /ID# 256096
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Completed
        • Fakultni nemocnice Motol a Homolka /ID# 256547
  • France
      • Paris, France, 75015
        • Recruiting
        • AP-HP - Hopital Necker /ID# 255608
    • Centre-Val de Loire
      • Tours, Centre-Val de Loire, France, 37044
        • Recruiting
        • CHRU Tours - Hopital Gatien de Clocheville /ID# 255052
    • New Aquitaine
      • Bordeaux, New Aquitaine, France, 33076
        • Recruiting
        • CHU Bordeaux - Hopital Pellegrin /ID# 257060
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • Recruiting
        • CHU Toulouse - Hopital Paule de Viguier /ID# 255609
    • Rhone
      • Bron, Rhone, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 255443
  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80337
        • Recruiting
        • Dr. von Haunerschen Kinderspital /ID# 255577
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitaetsklinikum Muenster /ID# 256762
  • Israel
    • Central District
      • Petah Tikva, Central District, Israel, 4920235
        • Recruiting
        • Schneider Children's Medical Center /ID# 254950
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Recruiting
        • Shaare Zedek Medical Center /ID# 254951
  • Italy
      • Messina, Italy, 98125
        • Recruiting
        • Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044
    • Genova
      • Genoa, Genova, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini /ID# 255262
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 255045
    • Roma
      • Rome, Roma, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù /ID# 255043
  • Japan
    • Aichi-ken
      • Ōbu, Aichi-ken, Japan, 474-8710
        • Recruiting
        • Aichi Children'S Health And Medical Center /ID# 272085
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital - Kashiwanoha /ID# 268409
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital /ID# 268418
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Recruiting
        • Gunma University Hospital /ID# 270560
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 861-8520
        • Recruiting
        • Japanese Red Cross Kumamoto Hospital /ID# 268586
    • Osaka
      • Izumi-Shi, Osaka, Japan, 594-1101
        • Recruiting
        • Osaka Women's and Children's Hospital /ID# 268419
    • Saitama
      • Saitama-shi, Saitama, Japan, 330-8777
        • Recruiting
        • Saitama Children's Medical Center /ID# 268410
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital /ID# 269175
      • Fuchu-shi, Tokyo, Japan, 183-8561
        • Recruiting
        • Tokyo Metropolitan Children's Medical Center /ID# 268415
      • Setagaya City, Tokyo, Japan, 157-8535
        • Recruiting
        • National Center For Child Health And Development /ID# 268420
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Recruiting
        • Amsterdam UMC, locatie AMC /ID# 254827
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Completed
        • Gastromed Sp. z o.o /ID# 255939
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 04-730
        • Recruiting
        • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Puerto Rico Health Institute /ID# 255071
      • San Juan, Puerto Rico, 00909-1711
        • Recruiting
        • Clinical Research Puerto Rico /ID# 266479
  • South Korea
      • Daegu, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital /ID# 255817
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital /ID# 255318
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Recruiting
        • Yonsei University Health System Severance Hospital /ID# 256976
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Recruiting
        • Samsung Medical Center /ID# 255284
  • Spain
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Nino Jesus /ID# 255012
      • Málaga, Spain, 29011
        • Recruiting
        • Hospital Regional Universitario de Malaga /ID# 257553
    • A Coruna
      • Ferrol, A Coruna, Spain, 15405
        • Recruiting
        • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 118 83
        • Recruiting
        • Sodersjukhuset /ID# 255239
      • Stockholm, Stockholm County, Sweden, 171 76
        • Recruiting
        • Astrid Lindgrens Barnsjukhus /ID# 255240
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 46
        • Recruiting
        • Sahlgrenska Universitetssjukhuset /ID# 255236
        • Contact:
          • Site Coordinator
          • Phone Number: +46313435865
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital, Universitaetsspital Bern /ID# 255321
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8032
        • Recruiting
        • University Children's Hospital Zurich - Eleonorenstiftung /ID# 255337
  • Taiwan
      • Changhua City, Changhua County, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital /ID# 256082
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital /ID# 255679
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi University Medical Faculty /ID# 255086
      • Istanbul, Turkey (Türkiye), 34453
        • Recruiting
        • Sariyer Hamidiye Etfal Eğitim Ve Araştirma Hastanesi /ID# 257143
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020
      • Kocaeli, Turkey (Türkiye), 41380
        • Recruiting
        • Kocaeli University Med Faculty /ID# 256922
  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Recruiting
        • Birmingham Women's and Children's NHS Foundation Trust /ID# 255759
    • England
      • Sheffield, England, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital NHS Foundation Trust /ID# 255758
        • Contact:
          • Site Coordinator
          • Phone Number: +44 114 273 0522
    • Greater London
      • London, Greater London, United Kingdom, E1 2ES
        • Recruiting
        • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Recruiting
        • Phoenix Children's Hospital /ID# 255766
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital /ID# 255762
    • California
      • Oakland, California, United States, 94609
        • Recruiting
        • UCSF Benioff Children's Hospital - Oakland /ID# 258327
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado - Aurora /ID# 255764
    • Florida
      • Orlando, Florida, United States, 32806-1141
        • Recruiting
        • Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Riley Hospital for Children /ID# 256454
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital /ID# 255767
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413-2195
        • Recruiting
        • MNGI Digestive Health, P. A. /ID# 255366
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Goryeb Childrens Hospital /ID# 256452
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai /ID# 254880
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic - Cleveland /ID# 256453
        • Contact:
          • Site Coordinator
          • Phone Number: 216-636-2007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI
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 participants who complete SS1 are eligible to enter SS2.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Time Frame: At 64 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
At 64 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time Frame: At 64 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
At 64 weeks
Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab
Time Frame: Up to approximately Week 64
Cmax of risankizumab
Up to approximately Week 64
Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab
Time Frame: Up to approximately 64 weeks
Tmax of risankizumab
Up to approximately 64 weeks
Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
Time Frame: Up to approximately 64 weeks
AUCtau of risankizumab
Up to approximately 64 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
Time Frame: At 12 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
At 12 weeks
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
Time Frame: At 12 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
At 12 weeks
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Time Frame: At 12 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
At 12 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Time Frame: At 64 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
At 64 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
Time Frame: At 64 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
At 64 weeks
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving PCDAI Clinical Remission
Time Frame: At 64 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
At 64 weeks
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per SES-CD
Time Frame: At 64 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
At 64 weeks
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
Time Frame: At 12 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
At 12 weeks
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
Time Frame: At 12 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
At 12 weeks
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Time Frame: At 12 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
At 12 weeks
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Time Frame: At 64 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
At 64 weeks
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
Time Frame: At 64 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
At 64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16-194
  • 2022-502050-14-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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