Risankizumab for Crohn's Disease

(FORTIFY Trial)

Not currently recruiting at 942 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Risankizumab

Disqualifiers: Colonic dysplasia, Colon cancer, Lymphoproliferative disease, others

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: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called risankizumab to evaluate its effectiveness and safety for people with Crohn's Disease, a condition characterized by inflammation of the digestive tract. The study consists of four parts, each examining different uses of risankizumab, including its long-term effects and patient experiences with self-injection. Individuals who have previously responded well to risankizumab and do not have chronic infections or a history of certain diseases may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment for Crohn's Disease.

Do I need to stop my current medications for the Risankizumab trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants must comply with prior and current medication requirements from previous studies, so it's best to discuss your specific situation with the study team.

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

Research has shown that risankizumab is generally well-tolerated by people with Crohn's disease. Many studies have examined its safety. The most common side effects remain consistent regardless of administration method—whether by IV (intravenous), under the skin (subcutaneous), or with an on-body injector. These side effects include colds, headaches, and joint pain.

In long-term studies, people with Crohn's disease managed risankizumab well, with no new safety issues reported. However, one rare case of a more serious side effect, a liver injury, occurred in a patient during the initial treatment phase.

Overall, the safety data suggest that risankizumab is safe for many people, though some side effects can occur. It is important to discuss any concerns with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about risankizumab for Crohn's disease because it targets a different part of the immune system than most current treatments. While standard therapies like corticosteroids and TNF inhibitors work by suppressing the immune system generally, risankizumab specifically blocks IL-23, a protein that plays a key role in inflammation. This more precise action could offer better relief from symptoms with potentially fewer side effects. Additionally, risankizumab offers flexible administration options, including intravenous and subcutaneous forms, which can be tailored to patient needs.

What evidence suggests that this trial's treatments could be effective for Crohn's disease?

Research has shown that risankizumab effectively treats moderate-to-severe Crohn's disease. Studies have found that it helps patients achieve early clinical remission, significantly reducing or eliminating symptoms. In real-world settings, about 58% of patients improved without needing steroids. Long-term evidence also suggests that risankizumab remains safe and effective over time. This trial will evaluate different methods of administering risankizumab, including IV, subcutaneous injection, and on-body injector, all of which have shown promising results in managing Crohn's disease. ^{3 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study

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

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.

Exclusion Criteria

I am not allergic to risankizumab or its ingredients, including those from Chinese hamster ovary cells, and have not had a bad reaction to it in past studies.

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

I have not been diagnosed with high grade colonic dysplasia or colon cancer in previous AbbVie studies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maintenance therapy with risankizumab or placebo for 52 weeks

52 weeks

Open-label extension

Participants receive open-label risankizumab to evaluate long-term safety and efficacy

Up to Week 220

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo for Risankizumab IV
• Placebo for Risankizumab SC
• Risankizumab IV
• Risankizumab On-Body Injector (OBI)
• Risankizumab SC

Trial Overview 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.

How Is the Trial Designed?

Group I: Risankizumab On-Body Injector and Open Label (Sub-Study 4) Experimental Treatment 2 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 Treatment 1 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 Treatment 3 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 Treatment 2 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 Treatment 1 Intervention

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

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

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

Group VII: CTE: Open Label Continuous Treatment Extension Experimental Treatment 1 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 Group 1 Intervention

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

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

Published Research Related to This Trial

In a study of 100 patients with moderate-to-severe Crohn's disease who had previously failed multiple treatments, risankizumab achieved a steroid-free clinical remission rate of 45.8% and a clinical response rate of 78.5% by week 12, indicating its effectiveness in a real-world setting.

The treatment was generally well-tolerated, with 20 adverse events reported, including 7 serious cases, but the majority of patients experienced significant improvements in their condition, highlighting risankizumab's potential as a viable option for refractory Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study. Fumery, M., Defrance, A., Roblin, X., et al.[2023]

In a long-term study of 65 patients with moderate-to-severe Crohn's disease, risankizumab was well tolerated over a median of 33 months, with no new safety concerns and a low rate of serious adverse events (24.6 events/100 patient-years).

Efficacy was maintained throughout the study, with over 71% of patients achieving clinical remission and more than 42% achieving endoscopic remission, indicating that risankizumab remains effective for long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study. Ferrante, M., Feagan, BG., Panés, J., et al.[2022]

In a study involving 108 patients with moderately to severely active Crohn's disease, extended intravenous treatment with risankizumab significantly improved clinical remission rates, with 53% of patients achieving remission by week 26 after 12 weeks of treatment.

Risankizumab was well tolerated, with most adverse events being mild or moderate, and it successfully maintained remission in 71% of patients at week 52, indicating its potential as a safe and effective long-term treatment option for Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab in patients with moderate to severe Crohn's disease: an open-label extension study. Feagan, BG., Panés, J., Ferrante, M., et al.[2022]

Subcutaneous risankizumab, a selective anti-IL-23 antibody, has been shown to be an effective maintenance therapy for patients with moderately to severely active Crohn's disease, achieving higher rates of clinical remission and endoscopic response compared to placebo in a study involving 542 participants.

The treatment was well tolerated, with adverse event rates similar across all groups, indicating that risankizumab could be a safe new option for patients who need ongoing management of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Ferrante, M., Panaccione, R., Baert, F., et al.[2022]

In a study involving 198 Asian patients with moderate-to-severe Crohn's disease, risankizumab demonstrated significant efficacy, with 61.4% achieving clinical remission and 40.0% showing endoscopic response at week 12, compared to placebo.

In the maintenance phase, 75.0% of patients receiving the higher dose of risankizumab (360 mg) achieved clinical remission at week 52, indicating that risankizumab is both effective and well tolerated in Asian patients, similar to results seen in non-Asian populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of risankizumab for Crohn's disease in patients from Asian countries: a post hoc subanalysis of the global phase 3 ADVANCE, MOTIVATE, and FORTIFY studies. Gao, X., Fujii, T., Ye, BD., et al.[2023]

Risankizumab, an IL-23 p19 inhibitor, demonstrated significant efficacy in inducing clinical remission and endoscopic response in patients with moderately to severely active Crohn's disease, with remission rates of up to 45% compared to 25% in the placebo group in the ADVANCE trial.

The treatment was well tolerated, with a similar incidence of adverse events across all groups, and the one death in the risankizumab group was determined to be unrelated to the drug, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. D'Haens, G., Panaccione, R., Baert, F., et al.[2022]

Risankizumab-rzaa, a selective IL-23 inhibitor, has been shown to significantly improve clinical remission and endoscopic response in patients with moderate to severe Crohn's disease, based on results from three phase 3 studies involving multiple patients.

The safety profile of risankizumab-rzaa is comparable to other advanced therapies for Crohn's disease, with common side effects including nasopharyngitis and abdominal pain, making it a viable treatment option for patients who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab-rzaa: A New Therapeutic Option for the Treatment of Crohn's Disease. Choi, D., Sheridan, H., Bhat, S.[2023]

Risankizumab was evaluated as an induction therapy for Crohn's disease in two phase 3 trials (ADVANCE and MOTIVATE), demonstrating significant efficacy in achieving clinical remission among participants.

The results indicated that risankizumab effectively reduced disease activity in patients with Crohn's disease, suggesting it could be a promising treatment option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In active Crohn disease, risankizumab increased clinical remission and endoscopic response at 12 wk. Oliver, D., Talley, NJ.[2022]

Citations

1. skyrizihcp.com skyrizihcp.com/gastroenterology/crohns-disease/efficacy

Efficacy Data - SKYRIZI® (risankizumab-rzaa) for Crohn's Risankizumab induces early clinical remission and response in patients with moderate-to-severe Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40857638/

Long-term Outcomes of Patients with Crohn's Disease ... Background: Cumulative data suggest that risankizumab is an effective and safe treatment for patients with Crohn's disease (CD).

3. mayoclinic.org mayoclinic.org/medical-professionals/digestive-diseases/news/examining-the-real-world-effectiveness-and-safety-of-risankizumab-in-patients-with-crohns-disease/mac-20589059

Examining the real-world effectiveness and safety of ... Researchers shared real-world effectiveness data and demonstrated how RZB performs in patients with prior therapy exposure and other ...

4. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i1818/7968109

P0978 Effectiveness of risankizumab in moderate-to-severe ... In this real-world, multicentric, Canadian study, risankizumab was an effective therapy in the management of Crohn's Disease in a population ...

5. cghjournal.org cghjournal.org/article/S1542-3565(24)00423-3/fulltext

Long-term Outcome of Risankizumab in Crohn's Disease Few real-world data on risankizumab effectiveness are currently available. ... Phase III studies MOTIVATE and ADVANCE evaluated the efficacy of IV ...

6. skyrizihcp.com skyrizihcp.com/gastroenterology/crohns-disease/safety

Safety Profile - SKYRIZI® (risankizumab-rzaa) for Crohn's Most common (>3%) adverse reactions associated with SKYRIZI in Crohn's disease are upper respiratory infections, headache, and arthralgia in induction and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8684487/

Long-Term Safety and Efficacy of Risankizumab Treatment in ... Long-term maintenance treatment with subcutaneous risankizumab 180 mg every 8 weeks was well tolerated by patients with Crohn's disease, with no new safety ...

8. va.gov va.gov/formularyadvisor/DOC_PDF/MON_Risankizumab-rzaa_SKYRIZI_in_Crohns_Disease_Monograph_Mar_2023.pdf

Risankizumab-rzaa (SKYRIZI) in Crohn's Disease National ... Safety Results from Clinical Trials: • Table 5 summarizes selected safety data from the phase 3 clinical trials. Page 4. Risankizumab-rzaa in CD Monograph. 4.

9. skyrizi.com skyrizi.com/crohns

take control of your crohn's with skyrizi The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include: upper respiratory infections, headache, joint pain ...