Ulcerative Colitis
Phase 3 Study of Risankizumab in Children With Ulcerative Colitis
This study is investigating how risankizumab moves through the body and assessing its safety and effects in children ages 2 to 17 with moderately to severely active ulcerative colitis.
Registry title: A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
11 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Risankizumab
- Design
- Randomized · Double
- Central study contact
- ABBVIE CALL CENTER844-663-3742abbvieclinicaltrials@abbvie.com
- Sponsor
- AbbVie
Research question
How does weight-based risankizumab move through the body, and what are its safety and disease-activity outcomes in children with moderately to severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for children ages 2 through 17.
- The study is looking for children with moderately to severely active ulcerative colitis.
- The registry requires a modified Mayo Score of 5 to 9 and an endoscopic subscore of 2 to 3 confirmed by a central reader.
- The registry requires intolerance or an inadequate response to at least one listed ulcerative colitis treatment category.
Participation overview
What participation may involve
Participation may span induction, randomized maintenance, and an open-label extension, with risankizumab given by intravenous infusion first and by injection under the skin in later periods. What participation may involve: - Receive weight-based risankizumab by intravenous infusion during the 12-week induction period. - If proceeding to maintenance, receive one of two randomized risankizumab doses by injection under the skin during a 52-week double-blind period. - If proceeding to the extension, receive risankizumab by injection under the skin for up to 208 weeks, with treatment based on the response during maintenance. - Attend regular hospital or clinic visits for medical assessments, blood tests, side-effect checks, and questionnaires. The registry reports a 12-week induction period, a 52-week maintenance period, a 208-week open-label extension, and approximately 140 days of follow-up; not every participant will necessarily enter every period. The registry says participants will attend regular visits at a hospital or clinic but does not report the number or timing of visits.
Study interventions
What participants may receive or do
- Risankizumab: During the 12-week induction period, participants may receive a weight-based dose of risankizumab through an intravenous infusion.
- Risankizumab: During maintenance and the open-label extension, participants may receive weight-based risankizumab by injection under the skin; maintenance uses one of two randomized doses.
Study design
How the comparison works
This Phase 3 study has an open-label 12-week induction period, a randomized double-blind 52-week maintenance period, and an open-label 208-week extension for participants who proceed to those stages. Participants who complete induction may enter maintenance, where they are randomly assigned to risankizumab Dose A or Dose B. During maintenance, participants and investigators are masked to whether Dose A or Dose B is assigned; induction and the extension are open-label. The randomized maintenance comparison is between two weight-based risankizumab doses, labeled Dose A and Dose B.
Reported activities
Procedures and tests
- Intravenous infusion of risankizumab during induction.
- Risankizumab injection under the skin during maintenance and the extension.
- Blood tests and other medical assessments.
- Checks for side effects.
- Questionnaires completed during study participation.
- A screening colonoscopy is required to confirm the ulcerative colitis history and exclude current infection, colonic dysplasia, or malignancy.
- Disease activity assessments include the modified Mayo Score, stool-frequency and rectal-bleeding subscores, and an endoscopic subscore.
- Blood sampling is used to assess risankizumab concentration and how the drug moves through the body.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 2 through 17 years old.
- Participants must have active ulcerative colitis with a modified Mayo Score of 5 to 9 and an endoscopic subscore of 2 to 3 confirmed by a central reader.
- Participants must have intolerance or an inadequate response to at least one listed treatment category, subject to the protocol and country-specific exception for aminosalicylates.
- Ulcerative colitis must have been documented for at least three months before baseline, with screening colonoscopy confirmation and pathology consistent with the diagnosis.
Possible reasons someone may not be able to join
- Participants are excluded if they had major surgery within 12 weeks before baseline or have major surgery planned during the study.
- Participants are excluded for another clinically significant condition or investigator-determined reason that could interfere with participation, make study treatment unsuitable, or increase risk.
Important unknowns
What the record does not make clear
- The registry mentions regular hospital or clinic visits but does not give their number, frequency, or schedule.
- The record does not clearly state which current ulcerative colitis treatments may continue during each study period.
- Medication washout requirements and their timing are not reported.
- The registry does not describe rescue-treatment options if ulcerative colitis worsens.
- A screening colonoscopy and endoscopic outcome assessments are reported, but the complete endoscopy schedule is not provided.
- The record does not state which study-related or routine-care costs are covered or billed to insurance.
- Compensation is not described.
- Travel, lodging, meal, and parking support are not described.
- The record does not say whether any visits or assessments can be completed remotely.
- The record does not explain whether risankizumab will be available after study participation ends.
- The study and listed sites are marked recruiting, but the record does not establish which age cohort or study stage each site is currently enrolling.
Before contacting the site
Questions for the study team
- How many hospital or clinic visits are required in each study period, and how long do they usually take?
- Which current ulcerative colitis medicines may continue, and are any washout periods required?
- How many colonoscopies or other endoscopic procedures are required after screening, and will anesthesia or sedation be used?
- What happens if ulcerative colitis symptoms worsen or a participant does not respond during induction or maintenance?
- Which age cohort and study period is the nearest site currently enrolling?
- Which costs are covered, and is assistance available for travel, lodging, parking, meals, or time?
- What treatment options are available after participation ends?
Before changing care
Questions for your gastroenterologist
- How could the study's treatment plan affect the child's current ulcerative colitis medicines?
- How stable is the child's disease now, and what concerns would you have about changing treatment or entering a washout period?
- What approved treatment alternatives should we compare with the study's induction, maintenance, and long-term extension plan?
- How should the gastroenterology and research teams coordinate disease monitoring, colonoscopies, and care if symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- AbbVie
- Organization class
- Industry
- Organization study ID
- M19-751
- Lead sponsor
- AbbVie
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Sequential
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Child
Study 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
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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.
Interventions: Drug: Risankizumab
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: Drug: Risankizumab
Interventions
Drug
Risankizumab
Risankizumab intravenous (IV) infusion
Drug
Risankizumab
Risankizumab subcutaneous (SC) injection
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (4)
- 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).Registry-derived · unreviewed
- Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- \- 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.Registry-derived · unreviewed
Exclusion criteria (2)
- 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).Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
Time frame: At Week 64
Maximum observed plasma concentration (Cmax)
Primary outcome
PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)
Time frame: At Week 64
Maximum observed plasma concentration (Cmax)
Primary outcome
PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)
Time frame: At Week 64
Time to maximum plasma concentration (Tmax)
Primary outcome
PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
Time frame: At Week 64
Time to maximum plasma concentration (Tmax)
Primary outcome
PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
Time frame: At Week 64
Area under the serum concentration-time curve over the dosing interval (AUCtau)
Primary outcome
PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
Time frame: At Week 64
Area under the serum concentration-time curve over the dosing interval (AUCtau)
Primary outcome
Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS
Time frame: At Week 64
Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
Primary outcome
Number of Participants With Adverse Events
Time frame: Up to 292 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related
Secondary outcome
PK Lead-In Cohort 1: Achievement of clinical remission per mMS among Week 12 responders per mMS
Time frame: At Week 64
Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
Secondary outcome
PK Lead-In Cohort 2: Achievement of clinical remission per mMS among Week 12 responders per mMS
Time frame: At Week 64
Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
Secondary outcome
PK Lead-In Cohort 1: Achievement of clinical remission per mMS
Time frame: At Week 12
Clinical remission on the mMS is defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
Secondary outcome
PK Lead-In Cohort 2: Achievement of clinical remission per mMS
Time frame: At Week 12
Clinical remission on the mMS is defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
Secondary outcome
PK Lead-In Cohort 1: Achievement of clinical response per mMS
Time frame: At Week 12
Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.
Secondary outcome
PK Lead-In Cohort 2: Achievement of clinical response per mMS
Time frame: At Week 12
Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.
Secondary outcome
PK Lead-In Cohort 1: Achievement of endoscopic improvement
Time frame: At Week 12
Endoscopic improvement defined as MES ≤ 1
Secondary outcome
PK Lead-In Cohort 2: Achievement of endoscopic improvement
Time frame: At Week 12
Endoscopic improvement defined as MES ≤ 1
Secondary outcome
PK Lead-In Cohort 1: Symptomatic response per partial mMS
Time frame: At Week 12
Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1.
Secondary outcome
PK Lead-In Cohort 2: Symptomatic response per partial mMS
Time frame: At Week 12
Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1.
Secondary outcome
PK Lead-In Cohort 1: Achievement of clinical response per mMS among Week 12 responders per mMS
Time frame: At Week 64
Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.
Secondary outcome
PK Lead-In Cohort 2: Achievement of clinical response per mMS among Week 12 responders per mMS
Time frame: At Week 64
Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.
Secondary outcome
PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS
Time frame: At Week 64
Endoscopic improvement defined as MES ≤ 1
Secondary outcome
PK Lead-In Cohort 2: Achievement of endoscopic improvement among Week 12 responders per mMS
Time frame: At Week 64
Endoscopic improvement defined as MES ≤ 1
Secondary outcome
PK Lead-In Cohort 1: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS
Time frame: Up to Week 64
Secondary outcome
PK Lead-In Cohort 2: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS
Time frame: Up to Week 64
Secondary outcome
Expansion Cohort 3: Achievement of clinical remission per mMS
Time frame: At Week 12
Secondary outcome
Expansion Cohort 3: Achievement of clinical response per mMS
Time frame: At Week 12
Secondary outcome
Expansion Cohort 3: Achievement of endoscopic improvement
Time frame: At Week 12
Secondary outcome
Expansion Cohort 3: Symptomatic response per partial mMS
Time frame: At Week 12
Secondary outcome
Expansion Cohort 3: Achievement of clinical response per mMS among Week 12 responders per mMS
Time frame: At Week 64
Secondary outcome
Expansion Cohort 3: Achievement of endoscopic improvement among Week 12 responders per mMS
Time frame: At Week 64
Secondary outcome
Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS among Week 12 responders per mMS
Time frame: At Week 64
Recruiting locations in the United States
Phoenix Children's Hospital /ID# 273015
RecruitingPhoenix, Arizona, 85016, United States
Rady Children's Hospital /ID# 271873
RecruitingSan Diego, California, 92123, United States
University of California San Francisco - Mission Bay /ID# 273022
RecruitingSan Francisco, California, 94158, United States
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue /ID# 271585
RecruitingMiami, Florida, 33155, United States
Childrens Center For Digestive Health Care /ID# 273228
RecruitingAtlanta, Georgia, 30342, United States
University of Chicago Medical Center /ID# 271588
RecruitingChicago, Illinois, 60637, United States
Goryeb Children's Hospital /ID# 271801
RecruitingMorristown, New Jersey, 07962, United States
University Hospitals Cleveland Medical Center /ID# 271831
RecruitingCleveland, Ohio, 44106, United States
The Children's Hospital of Philadelphia /ID# 273222
RecruitingPhiladelphia, Pennsylvania, 19104, United States
Upmc Children'S Hospital Of Pittsburgh /ID# 272328
RecruitingPittsburgh, Pennsylvania, 15224, United States
Patewood Medical Campus /ID# 272477
RecruitingGreenville, South Carolina, 29615, United States
This study also lists 46 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Jul 17, 2025
- Primary completion
- Jul 2034
- Overall completion
- Jul 2034
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.