Risankizumab for Inflammatory Bowel Disease

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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Risankizumab for treating inflammatory bowel disease?

Research shows that Risankizumab, which targets a specific protein called IL-23, is effective in helping patients with Crohn's disease, a type of inflammatory bowel disease, achieve clinical remission (symptom relief) and improve their condition as seen in medical tests. ^{1 2 3 4 5}

Is Risankizumab safe for humans?

Risankizumab has been studied for safety in people with Crohn's disease and plaque psoriasis. It has shown acceptable safety in clinical trials, but like any medication, it may have side effects. A study of real-world data is ongoing to better understand its safety profile. ^{3 4 6 7 8}

How is the drug Risankizumab unique for treating inflammatory bowel disease?

Risankizumab is unique because it targets the IL-23 protein, which plays a role in inflammation, and is effective for patients who do not respond well to anti-TNF treatments. This makes it a novel option for those with inflammatory bowel disease, particularly Crohn's disease. ^{2 3 4 5 9}

What is the purpose of this trial?

Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States. Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months. Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

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.

I do not have active tuberculosis.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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, 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 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 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 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]

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]

References

1. England 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. [2022]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Risankizumab-rzaa: A New Therapeutic Option for the Treatment of Crohn's Disease. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. [2020]