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
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
2 other identifiers
interventional
110
21 countries
85
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2023
Longer than P75 for phase_3
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
August 16, 2023
CompletedStudy Start
First participant enrolled
December 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
March 18, 2026
March 1, 2026
5.3 years
August 10, 2023
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
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)
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
Cmax of risankizumab
Up to approximately Week 64
Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab
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
AUCtau of risankizumab
Up to approximately 64 weeks
Secondary Outcomes (12)
Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
At 12 weeks
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
At 12 weeks
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
At 12 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
At 64 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
At 64 weeks
- +7 more secondary outcomes
Study Arms (15)
PK Cohort 1: SS1
EXPERIMENTALCohort 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.
PK Cohort 1: SS2 Dose A
EXPERIMENTALCohort 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.
PK Cohort 1: SS2 Dose B
EXPERIMENTALCohort 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.
PK Cohort 1: SS3 Dose A
EXPERIMENTALCohort 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.
PK Cohort 1: SS3 Dose B
EXPERIMENTALCohort 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.
PK Cohort 2: SS1
EXPERIMENTALCohort 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.
PK Cohort 2: SS2 Dose A
EXPERIMENTALCohort 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.
PK Cohort 2: SS2 Dose B
EXPERIMENTALCohort 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.
PK Cohort 2: SS3 Dose A
EXPERIMENTALCohort 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.
PK Cohort 2: SS3 Dose B
EXPERIMENTALCohort 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.
Expansion Cohort 3: SS1
EXPERIMENTALCohort 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.
Expansion Cohort 3: SS2 Dose A
EXPERIMENTALCohort 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.
Expansion Cohort 3: SS2 Dose B
EXPERIMENTALCohort 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.
Expansion Cohort 3: SS3 Dose A
EXPERIMENTALCohort 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.
Expansion Cohort 3: SS3 Dose B
EXPERIMENTALCohort 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.
Interventions
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
- A diagnosis of CD prior to 2 years of age.
- A diagnosis or suspected diagnosis of a primary immunodeficiency.
- 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.
- Ostomy or ileoanal pouch.
- Diagnosis of short gut or short bowel syndrome.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (85)
Phoenix Children's Hospital /ID# 255766
Phoenix, Arizona, 85016-7710, United States
Arkansas Children's Hospital /ID# 255762
Little Rock, Arkansas, 72202, United States
UCSF Benioff Children's Hospital - Oakland /ID# 258327
Oakland, California, 94609, United States
Children's Hospital Colorado - Aurora /ID# 255764
Aurora, Colorado, 80045, United States
Arnold Palmer Hospital for Children Center Digestive Health & Nutrition - Orland /ID# 255437
Orlando, Florida, 32806-1141, United States
Indiana University Health Riley Hospital for Children /ID# 256454
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital /ID# 255767
Boston, Massachusetts, 02114, United States
MNGI Digestive Health, P. A. /ID# 255366
Minneapolis, Minnesota, 55413-2195, United States
Goryeb Childrens Hospital /ID# 256452
Morristown, New Jersey, 07960, United States
Icahn School of Medicine at Mount Sinai /ID# 254880
New York, New York, 10029, United States
Cleveland Clinic - Cleveland /ID# 256453
Cleveland, Ohio, 44195, United States
Uza /Id# 255114
Edegem, Antwerpen, 2650, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 255108
Brussels, Brussels Capital, 1200, Belgium
Universitair Ziekenhuis Brussel /ID# 255109
Jette, Brussels Capital, 1090, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 255620
Liège, Liege, 4000, Belgium
Universitair Ziekenhuis Leuven /ID# 255098
Leuven, Vlaams-Brabant, 3000, Belgium
Hospital Universite Enfants Reine Fabiola /ID# 255112
Brussels, 1020, Belgium
UMHAT Sveti Georgi /ID# 255386
Plovdiv, 4002, Bulgaria
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384
Sofia, 1606, Bulgaria
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358
Varna, 9009, Bulgaria
Alberta Children's Hospital /ID# 255357
Calgary, Alberta, T3B 6A8, Canada
Edmonton Clinic Health Academy /ID# 255361
Edmonton, Alberta, T6G 1C9, Canada
BC Children's Hospital /ID# 255359
Vancouver, British Columbia, V6H 3V4, Canada
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598
London, Ontario, N6A 5W9, Canada
Beijing Children's Hospital /ID# 256081
Beijing, Beijing Municipality, 100045, China
Peking University Third Hospital /ID# 255876
Beijing, Beijing Municipality, 100191, China
Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428
Guangzhou, Guangdong, 510620, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589
Guangzhou, Guangdong, 510655, China
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562
Zhengzhou, Henan, 450018, China
Hunan Children's Hospital /ID# 255610
Changsha, Hunan, 410007, China
Jiangxi Provincial Children's Hospital /ID# 255564
Nanchang, Jiangxi, 330006, China
Shengjing Hospital of China Medical University /ID# 255563
Shenyang, Liaoning, 110022, China
Children's Hospital of Shanghai /ID# 255531
Shanghai, Shanghai Municipality, 200062, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688
Shanghai, Shanghai Municipality, 200065, China
Vseobecna Fakultni Nemocnice v Praze /ID# 256096
Prague, Praha 17, 128 00, Czechia
Fakultní nemocnice v Motole /ID# 256547
Prague, Praha 5, 150 06, Czechia
CHRU Tours - Hopital Gatien de Clocheville /ID# 255052
Tours, Centre-Val de Loire, 37044, France
CHU Bordeaux - Hopital Pellegrin /ID# 257060
Bordeaux, Nouvelle-Aquitaine, 33076, France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 255443
Bron, Rhone, 69500, France
AP-HP - Hopital Necker /ID# 255608
Paris, 75015, France
CHU Toulouse - Hopital Paule de Viguier /ID# 255609
Toulouse, 31059, France
Dr. von Haunerschen Kinderspital /ID# 255577
Munich, Bavaria, 80337, Germany
Universitaetsklinikum Muenster /ID# 256762
Münster, North Rhine-Westphalia, 48149, Germany
Schneider Children's Medical Center /ID# 254950
Petah Tikva, Central District, 4920235, Israel
Shaare Zedek Medical Center /ID# 254951
Jerusalem, Jerusalem, 91031, Israel
IRCCS Istituto Giannina Gaslini /ID# 255262
Genoa, Genova, 16147, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 255045
Naples, Napoli, 80131, Italy
Ospedale Pediatrico Bambino Gesù /ID# 255043
Rome, Roma, 00165, Italy
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044
Messina, 98125, Italy
Aichi Children'S Health And Medical Center /ID# 272085
Ōbu, Aichi-ken, 474-8710, Japan
Tsujinaka Hospital - Kashiwanoha /ID# 268409
Kashiwa-shi, Chiba, 277-0871, Japan
Kurume University Hospital /ID# 268418
Kurume-shi, Fukuoka, 830-0011, Japan
Gunma University Hospital /ID# 270560
Maebashi, Gunma, 371-8511, Japan
Japanese Red Cross Kumamoto Hospital /ID# 268586
Kumamoto, Kumamoto, 861-8520, Japan
Osaka Women's and Children's Hospital /ID# 268419
Izumi-Shi, Osaka, 594-1101, Japan
Saitama Children's Medical Center /ID# 268410
Saitama-shi, Saitama, 330-8777, Japan
Institute of Science Tokyo Hospital /ID# 269175
Bunkyo-ku, Tokyo, 113-8519, Japan
Tokyo Metropolitan Children's Medical Center /ID# 268415
Fuchu-shi, Tokyo, 183-8561, Japan
National Center For Child Health And Development /ID# 268420
Setagaya City, Tokyo, 157-8535, Japan
Amsterdam UMC, locatie AMC /ID# 254827
Amsterdam, North Holland, 1105 AZ, Netherlands
Gastromed Sp. z o.o /ID# 255939
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938
Warsaw, Masovian Voivodeship, 04-730, Poland
Puerto Rico Health Institute /ID# 255071
Dorado, 00646, Puerto Rico
Clinical Research Puerto Rico /ID# 266479
San Juan, 00909-1711, Puerto Rico
Seoul National University Hospital /ID# 255318
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Yonsei University Health System Severance Hospital /ID# 256976
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Samsung Medical Center /ID# 255284
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Kyungpook National University Chilgok Hospital /ID# 255817
Daegu, 41404, South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614
Ferrol, A Coruna, 15405, Spain
Hospital Infantil Universitario Nino Jesus /ID# 255012
Madrid, 28009, Spain
Hospital Regional Universitario de Malaga /ID# 257553
Málaga, 29011, Spain
Sodersjukhuset /ID# 255239
Stockholm, Stockholm County, 118 83, Sweden
Astrid Lindgrens Barnsjukhus /ID# 255240
Stockholm, Stockholm County, 171 76, Sweden
Sahlgrenska Universitetssjukhuset /ID# 255236
Gothenburg, Västra Götaland County, 413 46, Sweden
University Children's Hospital Zurich - Eleonorenstiftung /ID# 255337
Zurich, Canton of Zurich, 8032, Switzerland
Inselspital, Universitaetsspital Bern /ID# 255321
Bern, 3010, Switzerland
National Taiwan University Hospital /ID# 255679
Taipei City, Taipei, 100, Taiwan
Changhua Christian Hospital /ID# 256082
Changhua City, Changhua County, 50006, Taiwan
Gazi University Medical Faculty /ID# 255086
Ankara, 06560, Turkey (Türkiye)
Sariyer Hamidiye Etfal Eğitim Ve Araştirma Hastanesi /ID# 257143
Istanbul, 34453, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020
Istanbul, 34899, Turkey (Türkiye)
Kocaeli University Med Faculty /ID# 256922
Kocaeli, 41380, Turkey (Türkiye)
Sheffield Children's Hospital NHS Foundation Trust /ID# 255758
Sheffield, England, S10 2TH, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757
London, Greater London, E1 2ES, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust /ID# 255759
Birmingham, B4 6NH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2023
First Posted
August 16, 2023
Study Start
December 11, 2023
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.