Recruiting
Phase 3

Risankizumab

Sponsor:

AbbVie

Code:

NCT05995353

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Risankizumab

Risankizumab

Study Details

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.

Conditions

Crohn's Disease

Study ID

NCT05995353

Start date

Dec 11, 2023

Status verified date

May, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

Risankizumab

Intravenous (IV) Infusion

Risankizumab

Subcutaneous (SC) Injection

Primary outcome measure

  • Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission [ Time Frame: 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 ]
  • Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab [ Time Frame: Up to approximately Week 64 ]
  • Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Phoenix Children's Hospital /ID# 255766

Recruiting

Phoenix, Arizona, United States, 85016-7710

Arkansas Children's Hospital /ID# 255762

Recruiting

Little Rock, Arkansas, United States, 72202

UCSF Benioff Children's Hospital - Oakland /ID# 258327

Recruiting

Oakland, California, United States, 94609

Children's Hospital Colorado - Aurora /ID# 255764

Recruiting

Aurora, Colorado, United States, 80045

Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437

Recruiting

Orlando, Florida, United States, 32806-1141

Indiana University Health Riley Hospital for Children /ID# 256454

Recruiting

Indianapolis, Indiana, United States, 46202

Massachusetts General Hospital /ID# 255767

Recruiting

Boston, Massachusetts, United States, 02114

MNGI Digestive Health, P. A. /ID# 255366

Recruiting

Minneapolis, Minnesota, United States, 55413-2195

Goryeb Childrens Hospital /ID# 256452

Recruiting

Morristown, New Jersey, United States, 07960

Icahn School of Medicine at Mount Sinai /ID# 254880

Recruiting

New York, New York, United States, 10029

Cleveland Clinic - Cleveland /ID# 256453

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Site Coordinator

216-636-2007

Alberta Children's Hospital /ID# 255357

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Edmonton Clinic Health Academy /ID# 255361

Recruiting

Edmonton, Alberta, Canada, T6G 1C9

BC Children's Hospital /ID# 255359

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

AbbVie

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Crohn's Disease
  • Risankizumab
  • Skyrizi
  • Pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-05-29.