Crohn'sRecruiting

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

Phase 3 · Testing Risankizumab · 85 sites · AbbVie

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Risankizumab (a drug) and Risankizumab (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

Participants are assigned to groups by chance (randomized).

It is blinded: participants and the study team do not know who receives what.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

Ages 2 to 17
Any sex

Some of the main requirements, copied from the record:

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)

Plus 1 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 110 participants are expected to take part.
Start date: 2023-12-11.
Main results expected around 2029-04 (estimate from the record).
85 study sites listed (80 marked recruiting) in Belgium, Bulgaria, Canada, China and Czechia and 16 more countries.

Main thing being measured

Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission (At 64 weeks)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Phase 3
Study type	Interventional
Conditions	Crohn's Disease
Lead sponsor	AbbVie
Enrollment	110 (estimated)
Start date	2023-12-11
Primary completion (est.)	2029-04
First posted	2023-08-16
Last updated	2026-09-23
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
ClinicalTrials.gov ID	NCT05995353

Interventions

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

Full eligibility criteria (from the record)

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.

Locations (85)

Show all 85 sites

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

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.