Risankizumab for Inflammatory Bowel Disease

Not currently recruiting at 2 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: AbbVie

Must be taking: Risankizumab

Disqualifiers: Major surgery, Active infections, HIV, others

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 7 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the amount of risankizumab, a drug for Crohn's Disease and ulcerative colitis, present in the breast milk of women with these conditions. Researchers aim to better understand the safety of breastfeeding while using this medication. The trial includes women at least 5 weeks postpartum who are exclusively breastfeeding and already taking risankizumab regularly. Participants will continue their medication and provide breast milk samples for analysis. The study includes regular check-ins and questionnaires to monitor any side effects. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment benefits more patients, offering valuable insights for breastfeeding mothers.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have already been receiving risankizumab maintenance therapy before joining the study.

What is the safety track record for risankizumab?

Research has shown that risankizumab is generally safe for conditions like Crohn's disease, plaque psoriasis, and psoriatic arthritis. Studies have found that colds, headaches, and joint pain are the most common side effects for Crohn's disease, affecting more than 3% of patients. Despite these side effects, the FDA has approved risankizumab for these conditions, indicating its safety. Prospective trial participants should always consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Risankizumab is unique because it specifically targets interleukin-23 (IL-23), a protein involved in inflammatory processes, which sets it apart from many other treatments for inflammatory bowel disease (IBD) that often target a broader range of inflammatory pathways. This targeted approach might offer more precise symptom control with potentially fewer side effects. Researchers are excited about its potential for better efficacy and safety in managing IBD, especially for patients who haven't responded well to other treatments like TNF inhibitors. Additionally, its convenient dosing schedule, administered once every eight weeks, could improve patient adherence and quality of life compared to more frequent dosing regimens of existing therapies.

What is the effectiveness track record for risankizumab in treating inflammatory bowel disease?

Research has shown that risankizumab effectively treats Crohn's disease, a type of inflammatory bowel disease (IBD). In studies, more than half of the patients experienced significant symptom improvement within three months, achieving clinical remission. Long-term data indicate that many patients remain symptom-free without needing steroids. Real-world evidence confirms risankizumab's effectiveness and safety, even for those who have tried other treatments. This drug is already approved for Crohn's disease, demonstrating its strong ability to manage IBD symptoms. ^{4 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 lactating women at least 5 weeks postpartum with Inflammatory Bowel Disease who have been treated with risankizumab. They must be exclusively breastfeeding or giving no more than one bottle of formula per day.

Inclusion Criteria

I have received at least 2 doses of risankizumab 360 mg every 8 weeks after giving birth.

Lactation is well established. The mother must be exclusively breastfeeding her infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study.

I gave birth at least 5 weeks ago.

Exclusion Criteria

I am HIV positive.

I have not had a serious infection in the last 2 weeks.

Participants who have any of the following medical diseases or conditions: Recent (within past 6 months) cerebrovascular accident or myocardial infarction; History of an organ transplant which requires continued immunosuppression; Active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue their established risankizumab maintenance therapy every 8 weeks postpartum

7 months

Regular visits at a hospital or clinic

Sample Collection

Pharmacokinetic samples are collected from breast milk at specified intervals

57 days

Visits on Day 1, Days 4 (± 1), 8 (± 2), 15 (± 3), 29 (± 3), and pre-dose on Day 57 (± 3)

Follow-up

Participants are monitored for safety and effectiveness after sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Risankizumab

Trial Overview The study assesses the levels of risankizumab, a drug used for psoriasis and Crohn's Disease, in breast milk. About 10 women from Israel or the US will participate over approximately 7 months, providing milk samples and undergoing medical assessments.

How Is the Trial Designed?

Group I: Pharmacokinetic samples Experimental Treatment 2 Interventions

Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of commercial risankizumab at pre-dose and 1 hour after dosing on Day 1, on Days 4 (± 1), 8 (± 2), 15 (± 3), 29 (± 3), and pre-dose on Day 57 (± 3). Participants will have already been taking commercial risankizumab and will continue on commercial risankizumab. Participants will not be provided risankizumab from the study. Participants must have received at least 2 doses of 360 mg of risankizumab SC every 8 weeks postpartum prior to start of participation in this study.

Risankizumab is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Skyrizi for:

• Moderate-to-severe Crohn's disease

Approved in United States as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis

Approved in European Union as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis
• Psoriatic arthritis

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

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]

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 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]

Risankizumab, a monoclonal antibody targeting IL-23, received its first global approval in March 2019 in Japan for treating various forms of psoriasis, including psoriasis vulgaris and psoriatic arthritis.

The drug is currently approved in multiple regions, including the USA and EU, for moderate-to-severe plaque psoriasis and is undergoing further clinical trials for other conditions like Crohn's disease and ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. McKeage, K., Duggan, S.[2020]

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]

In a study involving 106 patients with active Crohn's disease, risankizumab significantly reduced the expression of genes related to the IL-23/IL-17 axis and immune response pathways by Week 12, indicating its mechanism of action in treating the disease.

The transcriptomic changes in the colon after risankizumab treatment were linked to clinical and endoscopic remission, showing that the drug effectively modulates key biological pathways associated with Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective IL-23 Inhibition by Risankizumab Modulates the Molecular Profile in the Colon and Ileum of Patients With Active Crohn's Disease: Results From a Randomised Phase II Biopsy Sub-study. Visvanathan, S., Baum, P., Salas, A., et al.[2022]

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]

Upadacitinib and risankizumab effectively modify immune response mechanisms in patients with inflammatory bowel disease (IBD) who do not respond to anti-TNF-α therapies, as shown by significant decreases in upregulated immune modules and cell types associated with inflammation.

In a study involving tissue transcriptomic data from IBD patients, upadacitinib treatment led to a notable reduction in the expression of inflammatory markers and immune cell types in responders, indicating its potential to improve clinical outcomes in TNF-IR patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Response of Upadacitinib and Risankizumab Is Associated With Reduced Inflammatory Bowel Disease Anti-TNF-α Inadequate Response Mechanisms. Wang, J., Macoritto, M., Guay, H., et al.[2023]

In a large analysis of 10,235 reports from the FDA Adverse Event Reporting System, risankizumab was associated with 161 adverse events (AEs), including unexpected ones like myocardial infarction and pancreatitis, highlighting the need for careful monitoring.

The study identified that most AEs related to risankizumab were reported as serious, with a significant number of cases showing a gradual decrease in reported AEs over time, suggesting that the risks may diminish with continued use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system. Shu, Y., Chen, J., Ding, Y., et al.[2023]

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 ... Overall, 131/235 (55.7%) patients clinically responded at 3 months, and 121/233 (51.9%) were in clinical remission. At 12 months, rates of ...

5. cghjournal.org cghjournal.org/article/S1542-3565(24)00968-6/abstract

Long-term Effectiveness and Safety of Risankizumab in ... Primary outcomes were clinical remission and steroid-free clinical remission rates at weeks 12, 26, and 52. Univariate analysis followed by a ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38065372/

Risankizumab Effectiveness and Safety in Crohn's Disease Here, we describe the effectiveness and safety of risankizumab throughout the induction period in a real-world setting of a large tertiary center.

8. 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 ...

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

Risankizumab for Ulcerative Colitis: Two Randomized ... These 2 randomized clinical trials compare the efficacy and safety of risankizumab vs placebo during an induction trial and a maintenance ...