Risankizumab for Ulcerative Colitis

(REVAMP Trial)

Recruiting at 238 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: Targeted therapies

Disqualifiers: Crohn's disease, Active infection, 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

Duration: 44-46 weeks

530 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the safety and effectiveness of two treatments, risankizumab (an immunotherapy) and vedolizumab (a biologic therapy), for adults with moderate to severe ulcerative colitis (UC), a condition that causes inflammation in the colon. Participants will receive either risankizumab, starting with an IV dose followed by injections, or vedolizumab, administered as an IV throughout the study. The trial seeks individuals who have had UC for at least three months and have not used targeted therapies before. Participants will attend regular outpatient visits and undergo medical assessments to monitor treatment effects and safety. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should not have received any targeted therapies for UC before. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both risankizumab and vedolizumab have been studied for their safety in treating ulcerative colitis (UC). Risankizumab is generally well-tolerated, with common side effects including joint pain, fever, and injection site reactions. In one study, about 4% of patients were hospitalized due to severe UC, and a small number discontinued treatment because their disease remained active.

Vedolizumab also maintains a good safety record. Serious side effects are relatively rare, occurring at a rate of 1.2 per 100 patient-years. However, long-term studies revealed that some patients experienced serious infections. Despite these risks, both drugs are approved treatments for UC in several countries, indicating that their benefits often outweigh the potential side effects for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about risankizumab for ulcerative colitis because it offers a new approach by targeting interleukin-23 (IL-23), a protein involved in inflammation, with the aim of reducing the symptoms of this condition. Unlike other treatments that often target different inflammatory pathways, risankizumab specifically inhibits IL-23, which may lead to more effective and targeted relief. Additionally, risankizumab is initially administered intravenously for rapid induction, followed by a subcutaneous injection for maintenance, offering flexibility and potentially improving patient convenience. Meanwhile, vedolizumab, another treatment in the trial, focuses on blocking the migration of inflammatory cells to the gut, providing a different mechanism of action by targeting the gut specifically, which is promising for minimizing systemic side effects.

What is the effectiveness track record for risankizumab and vedolizumab in treating moderate to severe ulcerative colitis?

This trial will compare Risankizumab and Vedolizumab for treating ulcerative colitis (UC). Research has shown that Risankizumab yields promising results, with one study indicating that 1200 mg of Risankizumab helped more patients achieve clinical remission compared to those who did not receive it. By week 52, about 40% of patients remained in remission with Risankizumab. In contrast, the GEMINI I trial demonstrated that 42% of patients achieved clinical remission with Vedolizumab by week 52. Additionally, long-term data suggests that up to 88% of patients who initially responded to Vedolizumab stayed in remission. Both treatments, studied in separate arms of this trial, have effectively managed moderate to severe UC symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with moderate to severe Ulcerative Colitis (UC) for at least 3 months, who haven't responded well to certain UC medications like aminosalicylates and steroids, or can't tolerate them. Participants should have an active UC with specific scores on the modified Mayo Score.

Inclusion Criteria

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

I've had a bad reaction or no improvement from certain gut inflammation treatments.

I have been diagnosed with Ulcerative Colitis for at least 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive either risankizumab or vedolizumab. Risankizumab is administered IV during induction and SC during maintenance. Vedolizumab is administered IV throughout.

44-46 weeks

Regular outpatient visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Risankizumab
• Vedolizumab

Trial Overview The trial is testing the safety and effectiveness of two approved UC drugs: Risankizumab given first through IV then as injections, versus Vedolizumab given only through IV. About 530 adults will be randomly assigned to either drug for up to 71 weeks.

How Is the Trial Designed?

Group I: Risankizumab Group Active Control 1 Intervention

An induction dose of risankizumab intravenous (IV) will be administered at Baseline and Weeks 4 and 8. Starting at Week 12, participants will then receive either a lower or higher subcutaneous (SC) risankizumab maintenance dose, followed by the same dose every 8 weeks with the last dose at Week 44.

Group II: Vedolizumab Group Active Control 1 Intervention

Vedolizumab IV will be administered at Baseline, Weeks 2 and 6, and every 8 weeks with the last dose of vedolizumab IV at Week 46.

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. news.abbvie.com news.abbvie.com/2023-03-23-Risankizumab-SKYRIZI-R-Achieves-Primary-and-All-Secondary-Endpoints-in-Phase-3-Induction-Study-in-Patients-With-Ulcerative-Colitis

Risankizumab (SKYRIZI®) Achieves Primary and All ... Risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and fecal incontinence.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39804294/

Risankizumab efficacy and safety based on prior ... Conclusions: Risankizumab was effective and well tolerated, regardless of prior AT-IR status. Clinical trial registration numbers: INSPIRE [ ...

7. academic.oup.com academic.oup.com/ecco-jcc/article/19/4/jjaf025/8102792

Corticosteroid-sparing effects of risankizumab efficacy and ... This post hoc analysis evaluated the corticosteroid-sparing effects of risankizumab (RZB) therapy in patients with moderate-to-severe ulcerative colitis.

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 ...

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

Safety Profile - SKYRIZI® (risankizumab-rzaa) for UC Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions ...