Risankizumab for Ulcerative Colitis
(MIGHTY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how risankizumab, a medication already approved for ulcerative colitis (UC) in adults, works in children and teens with moderate to severe UC. Researchers aim to assess the safety and effectiveness of this treatment and its movement through the body. The trial consists of different stages, where participants receive the medication either through an IV or injection over time. Children with UC who have experienced symptoms for at least three months and have not responded well to other treatments might be suitable for this study. Participants must visit a hospital or clinic regularly for check-ups and tests. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for UC.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have shown intolerance or inadequate response to certain drugs, which might imply some changes to your current treatment. It's best to discuss this with the trial team for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that risankizumab is generally safe for people with ulcerative colitis (UC). In earlier studies, some patients experienced side effects. About 4% were hospitalized due to severe UC, and around 8% stopped taking the medication because their symptoms persisted. However, no patients required surgery to remove their colon, which is a positive sign for safety. Risankizumab is already approved for treating moderate to severe UC in adults, indicating confidence in its safety for this condition. Always consult a healthcare provider about the potential risks and benefits before joining a trial.12345
Why are researchers excited about this study treatment for ulcerative colitis?
Researchers are excited about risankizumab for ulcerative colitis because it targets a protein called IL-23, which plays a key role in the inflammation process. Unlike current treatments that often focus on broader immune suppression, risankizumab's targeted approach may offer improved effectiveness with potentially fewer side effects. Additionally, its administration through injections allows for precise dosing, which can enhance patient convenience and adherence compared to treatments that require more frequent dosing. This targeted mechanism and convenient delivery method could make risankizumab a promising option for managing ulcerative colitis.
What is the effectiveness track record for Risankizumab in treating ulcerative colitis?
Research has shown that risankizumab effectively treats ulcerative colitis (UC). In one study with 975 patients, a 1200 mg dose of risankizumab significantly increased the number of people whose symptoms disappeared. Another study found that after 52 weeks, 40.2% of patients taking a 180 mg dose and 37.6% of those taking a 360 mg dose were symptom-free. Long-term results indicate that risankizumab remains beneficial for up to 96 weeks. This trial will explore different dosing regimens of risankizumab in children, suggesting it could be a promising treatment option for managing UC in this population.23678
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for young patients with moderate to severely active Ulcerative Colitis. It includes children aged 2-18, divided into three cohorts based on age. Participants must have a diagnosis of UC and be able to attend regular hospital or clinic visits for treatment and monitoring.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive a weight-based induction regimen of risankizumab intravenously
Maintenance
Participants receive a randomized double-blind maintenance regimen of risankizumab subcutaneously
Open-label Extension
Participants receive risankizumab based on their response in the maintenance phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Risankizumab
Trial Overview
The study tests Risankizumab's safety, effectiveness, and how it moves through the body in pediatric UC patients. It has an induction period with intravenous dosing, followed by a randomized maintenance phase with subcutaneous doses, then an open-label extension for responders.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Citations
Risankizumab efficacy and safety based on prior ...
Results from this post hoc analysis demonstrate that risankizumab is effective and well tolerated for the treatment of UC in the non-AT-IR and ...
Risankizumab for Ulcerative Colitis: Two Randomized ...
Findings Among the 975 patients analyzed in the induction trial, 1200 mg of risankizumab significantly increased the rates of clinical remission ...
Efficacy - SKYRIZI® (risankizumab-rzaa) for UC
SKYRIZI® efficacy data for ulcerative colitis, including durable remission & early disease control. See Important Safety Information and Prescribing ...
Risankizumab is Superior to Placebo for Induction and ...
For the maintenance trial, clinical remission rates at week 52 were 40.2% (72/179) for 180 mg risankizumab vs 37.6% (70/186) for 360 mg ...
DOP014 Efficacy and safety up to 3 years of risankizumab ...
In this interim analysis of the OLE, a sustained benefit was observed with long-term RZB treatment up to 96 wks. The long-term safety profile for RZB remains ...
Safety Profile - SKYRIZI® (risankizumab-rzaa) for UC
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.
SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis
SKYRIZI is a prescription medicine used to treat moderate to severe ulcerative colitis in adults. IMPORTANT SAFETY INFORMATION
8.
journals.lww.com
journals.lww.com/ajg/fulltext/2025/10002/s1654_risankizumab_effectiveness_and_safety_in.1655.aspxS1654 Risankizumab Effectiveness and Safety in Ulcerative...
Two (4.1%) patients were hospitalized for severe UC and no patients underwent colectomy. Four (8.2%) patients stopped RZB due to clinically active disease, and ...
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