Recruiting
Phase 3

Risankizumab

Sponsor:

AbbVie

Code:

NCT07071519

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Risankizumab

Risankizumab

Study Details

Brief summary:

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.

Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC 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 maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 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

Ulcerative Colitis

Study ID

NCT07071519

Start date

Jul 28, 2025

Status verified date

Sep, 2026

Completion date

Jul, 2034

Anticipated

Primary completion date

Jul, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
  • Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:

aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.

\- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.

Exclusion Criteria:

  • Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).
  • Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.

Study Design

Enrollment

120 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 participants 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 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 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

Risankizumab intravenous (IV) infusion

Risankizumab

Risankizumab subcutaneous (SC) injection

Primary outcome measure

  • PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax) [ Time Frame: At Week 64 ]
  • PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax) [ Time Frame: At Week 64 ]
  • PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax) [ Time Frame: At Week 64 ]
  • PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax) [ Time Frame: At Week 64 ]
  • PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) [ Time Frame: At Week 64 ]
  • PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) [ Time Frame: At Week 64 ]
  • Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS [ Time Frame: At Week 64 ]
  • Number of Participants With Adverse Events [ Time Frame: Up to 292 Weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Phoenix Children's Hospital /ID# 273015

Recruiting

Phoenix, Arizona, United States, 85016

Rady Children's Hospital /ID# 271873

Recruiting

San Diego, California, United States, 92123

University of California San Francisco - Mission Bay /ID# 273022

Recruiting

San Francisco, California, United States, 94158

Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue /ID# 271585

Recruiting

Miami, Florida, United States, 33155

Childrens Center For Digestive Health Care /ID# 273228

Recruiting

Atlanta, Georgia, United States, 30342

University of Chicago Medical Center /ID# 271588

Recruiting

Chicago, Illinois, United States, 60637

Goryeb Children's Hospital /ID# 271801

Recruiting

Morristown, New Jersey, United States, 07962

University Hospitals Cleveland Medical Center /ID# 271831

Recruiting

Cleveland, Ohio, United States, 44106

The Children's Hospital of Philadelphia /ID# 273222

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Upmc Children'S Hospital Of Pittsburgh /ID# 272328

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Patewood Medical Campus /ID# 272477

Recruiting

Greenville, South Carolina, United States, 29615

University of Texas - Southwestern Medical Center /ID# 271835

Recruiting

Dallas, Texas, United States, 75235

Alberta Children's Hospital /ID# 272635

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Edmonton Clinic Health Academy /ID# 271168

Recruiting

Edmonton, Alberta, Canada, T6G 1C9

London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

AbbVie

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • risankizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-04.