What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as Risankizumab and Ustekinumab, which are monoclonal antibodies targeting IL-23, have several known side effects. These include an increased risk of infections, nasopharyngitis, and injection site reactions. Other potential adverse events may include headache, fatigue, and upper respiratory tract infections. Long-term safety data are still being gathered, but these treatments are generally well-tolerated with a favorable safety profile compared to other biologics.

What prior FDA approvals exist?

Several monoclonal antibodies targeting IL-23 and related pathways have been approved by the FDA for the treatment of Crohn's Disease. Ustekinumab, which blocks IL-12 and IL-23, is approved for patients who have failed other biologic therapies. Clinical trials have shown that ustekinumab can induce and maintain remission in Crohn's Disease patients. Vedolizumab, another monoclonal antibody, targets the alpha-4-beta-7 integrin and is used for moderate to severe Crohn's Disease. It has shown efficacy in both induction and maintenance phases. These treatments are similar to risankizumab, which specifically targets IL-23 and is currently being studied for its efficacy and safety in Crohn's Disease.

What other types of research exist?

Promising alternatives to Risankizumab for Crohn's Disease include Vedolizumab, a gut-selective antibody, and Ustekinumab, which has shown efficacy in inflammatory bowel disease. Both have been evaluated in clinical trials and offer different mechanisms of action.

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Monoclonal Antibodies

Risankizumab for Crohn's Disease (FORTIFY Trial)

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants have completed the study M16-006 or M15-991 and have achieved clinical response

Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark)

Must not have

Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 220

Awards & highlights

Pivotal Trial

Summary

This trial tests risankizumab, a medication for Crohn's disease, in patients who have already responded well to it. The goal is to see if continued use can maintain their improvement by reducing inflammation in the digestive tract. Risankizumab is approved by the FDA for treating moderate to severe Crohn's disease.

Who is the study for?

This trial is for people with moderately to severely active Crohn's Disease who've had a positive response to risankizumab in previous studies. They should be willing and able to self-inject the medication using an on-body injector, have been stable on their current dose for at least 16 weeks, and not require rescue treatment.

What is being tested?

The study tests the effectiveness of risankizumab as a maintenance therapy through four sub-studies: comparing it against placebo, exploring dosing regimens, assessing long-term safety and efficacy, and evaluating patient outcomes when administered via an On-Body Injector.

What are the potential side effects?

Risankizumab may cause side effects such as infections due to immune system suppression, allergic reactions if sensitive to its components or Chinese hamster ovary ingredients. Long-term risks include potential lymphoproliferative disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I completed study M16-006 or M15-991 and my condition improved.

Select...

I've been on a stable dose of risankizumab for over 16 weeks and passed 72 weeks in Sub-study 3 without needing rescue medication.

Select...

I completed study M16-006 or M15-991 and my condition improved.

Select...

I have been on a stable dose of risankizumab for over 16 weeks and passed 72 weeks in Sub-study 3 without needing rescue medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of diseases related to lymph nodes or spleen, like lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 220

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 220

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 220 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Sub-Study 1: Percentage of Participants With Endoscopic Response

Sub-Study 3: Number of Participants With Adverse Events

+4 more

Secondary study objectives

Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline

Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission

+9 more

Other study objectives

Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Sub-Study 2: Percentage of Participants With Endoscopic Response

Sub-Study 2: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Risankizumab On-Body Injector and Open Label (Sub-Study 4)Experimental Treatment2 Interventions

Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.

Group II: Open-label Risankizumab (Sub-Study 3)Experimental Treatment1 Intervention

Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.

Group III: Maintenance Risankizumab Dose 2 (Sub-Study 2)Experimental Treatment3 Interventions

Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Group IV: Maintenance Risankizumab Dose 1 (Sub-Study 2)Experimental Treatment2 Interventions

Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Group V: Double-blind Risankizumab Dose 2 (Sub-Study 1)Experimental Treatment1 Intervention

Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.

Group VI: Double-blind Risankizumab Dose 1 (Sub-Study 1)Experimental Treatment1 Intervention

Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.

Group VII: CTE: Open Label Continuous Treatment ExtensionExperimental Treatment1 Intervention

Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.

Group VIII: Double-blind Placebo for Risankizumab (Sub-Study 1)Placebo Group1 Intervention

Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease, particularly biologic therapies like Risankizumab, work by targeting specific components of the immune system to reduce inflammation. Risankizumab is a monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23), a cytokine involved in the inflammatory process. By inhibiting IL-23, Risankizumab helps to decrease the immune response that leads to the chronic inflammation characteristic of Crohn's Disease. This is crucial for patients as it can lead to reduced symptoms, improved quality of life, and potentially long-term remission. Other biologics, such as anti-TNF agents (e.g., infliximab, adalimumab) and ustekinumab (targeting IL-12 and IL-23), also work by modulating the immune system to control inflammation and prevent disease progression.