Risankizumab for Ulcerative Colitis

(MIGHTY Trial)

Recruiting at 22 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Major surgery, Significant medical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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

I have been diagnosed with ulcerative colitis for at least 3 months, confirmed by a recent colonoscopy.

My ulcerative colitis is active with a moderate to severe score.

I have not responded well to standard treatments for my condition.

Exclusion Criteria

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.

I haven't had major surgery in the last 12 weeks and don't plan to during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive a weight-based induction regimen of risankizumab intravenously

12 weeks

Regular visits at a hospital or clinic

Maintenance

Participants receive a randomized double-blind maintenance regimen of risankizumab subcutaneously

52 weeks

Regular visits at a hospital or clinic

Open-label Extension

Participants receive risankizumab based on their response in the maintenance phase

208 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

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?

Group I: PK Cohort 2: SS3 Dose B Experimental Treatment 1 Intervention

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.

Group II: PK Cohort 2: SS3 Dose A Experimental Treatment 1 Intervention

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.

Group III: PK Cohort 2: SS2 Dose B Experimental Treatment 1 Intervention

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.

Group IV: PK Cohort 2: SS2 Dose A Experimental Treatment 1 Intervention

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.

Group V: PK Cohort 2: SS1 Experimental Treatment 1 Intervention

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.

Group VI: PK Cohort 1: SS3 Dose B Experimental Treatment 1 Intervention

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.

Group VII: PK Cohort 1: SS3 Dose A Experimental Treatment 1 Intervention

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.

Group VIII: PK Cohort 1: SS2 Dose B Experimental Treatment 1 Intervention

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.

Group IX: PK Cohort 1: SS2 Dose A Experimental Treatment 1 Intervention

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.

Group X: PK Cohort 1: SS1 Experimental Treatment 1 Intervention

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

Group XI: Expansion Cohort 3: SS3 Dose B Experimental Treatment 1 Intervention

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.

Group XII: Expansion Cohort 3: SS3 Dose A Experimental Treatment 1 Intervention

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.

Group XIII: Expansion Cohort 3: SS2 Dose B Experimental Treatment 1 Intervention

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.

Group XIV: Expansion Cohort 3: SS2 Dose A Experimental Treatment 1 Intervention

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.

Group XV: Expansion Cohort 3: SS1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11772864/

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 ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2821291

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 ...

3. skyrizihcp.com skyrizihcp.com/gastroenterology/ulcerative-colitis/efficacy

Efficacy - SKYRIZI® (risankizumab-rzaa) for UC SKYRIZI® efficacy data for ulcerative colitis, including durable remission & early disease control. See Important Safety Information and Prescribing ...

4. gi.org gi.org/journals-publications/ebgi/dalal_sep2024/

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 ...

5. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i108/7966841

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 ...

6. skyrizihcp.com skyrizihcp.com/gastroenterology/ulcerative-colitis/safety

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.

7. skyrizi.com skyrizi.com/ulcerative-colitis

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.aspx

S1654 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 ...