Risankizumab for Healthy Subjects

No longer recruiting at 2 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Anti-interleukin-12/23

Disqualifiers: Epilepsy, Cardiac, Respiratory, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how risankizumab (Skyrizi) behaves in the body and its tolerability in healthy adults. Researchers are testing three different formulations to determine which one is absorbed best and is most comfortable for participants. As an initial step in studying this drug, only healthy individuals without major health issues can join. Those without serious health problems and not planning intense exercise soon might be a good fit. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new medication.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that risankizumab is generally safe. It is already used for conditions like psoriasis and psoriatic arthritis. The most common side effects are mild, such as colds, headaches, and fatigue. Some individuals might also experience redness or swelling at the injection site.

Long-term studies in people with psoriatic disease have not identified any new safety issues, indicating that risankizumab is usually well-tolerated over time. Treatments for Crohn's disease have noted similar side effects, such as joint pain and upper respiratory infections.

Overall, past studies suggest that risankizumab is safe. However, it is important to note that this current study is in the early stages (Phase 1), focusing on understanding how the body processes the drug and ensuring its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Risankizumab is unique because it belongs to a newer class of medications called interleukin-23 (IL-23) inhibitors, which work by targeting a specific protein involved in inflammation. Unlike traditional treatments for autoimmune conditions that might broadly suppress the immune system, Risankizumab zeroes in on IL-23, potentially offering more precise control of inflammation with fewer side effects. Researchers are excited about Risankizumab because it may provide quicker relief and better long-term management compared to existing therapies, which often take weeks to become effective. Additionally, the different formulations being tested could lead to more convenient dosing options, enhancing patient adherence and outcomes.

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

Research has shown that risankizumab effectively treats certain skin conditions. In studies involving individuals with moderate to severe plaque psoriasis, up to 86% experienced significant skin improvement, with many achieving almost complete clearing. Another study found that 60% of patients had completely clear skin after one year. Risankizumab has also shown promise in treating other conditions like Crohn's disease, with real-world evidence supporting its effectiveness. Overall, these results are promising for these conditions and explain why researchers continue to study risankizumab. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Inclusion Criteria

My weight is between 40 and 100 kg.

My BMI is between 18.0 and 32.0.

I am generally healthy based on recent medical exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of one of three formulations of Risankizumab on day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, relative bioavailability, and tolerability, with assessments up to day 140

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Risankizumab

How Is the Trial Designed?

Group I: Risankizumab Formulation 3 Experimental Treatment 1 Intervention

Participants will receive a single dose of Risankizumab formulation 3 on day 1.

Group II: Risankizumab Formulation 2 Experimental Treatment 1 Intervention

Participants will receive a single dose of Risankizumab formulation 2 on day 1.

Group III: Risankizumab Formulation 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of Risankizumab formulation 1 on day 1.

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40728772/

Long-Term Safety and Efficacy of Risankizumab to Treat ... At week 304, 86.0% of patients achieved PASI 90, 54.2% achieved PASI 100, 84.7% achieved sPGA 0/1, and 76.3% achieved DLQI 0/1 (using modified ...

2. skyrizihcp.com skyrizihcp.com/dermatology/psoriasis-efficacy

SKYRIZI® Efficacy In Moderate to Severe Plaque Psoriasis ... PASI 90 ACHIEVED BY 81% OF PATIENTS AT 1 YEAR · PASI 90 ACHIEVED BY 82% OF PATIENTS AT 1 YEAR · PASI 100 achieved by 60% of patients at 1 year · PASI 100 achieved ...

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. ophthalmologyadvisor.com ophthalmologyadvisor.com/news/risankizumab-shows-sustained-efficacy-across-grappa-psa-domains/

Risankizumab Shows Sustained Efficacy Across Psoriatic ... By week 100 of the KEEPsAKE 1 study, 64.3% of participants receiving continuous risankizumab achieved an at least 20% improvement using the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0190962223028487

Real-world effectiveness of risankizumab in patients with ... Among 287 patients with persistent risankizumab use at 1 year, most achieved clear or clear/almost clear skin and reported significant reductions in Dermatology ...

6. skyrizihcp.com skyrizihcp.com/dermatology/pso-psa-safety-profile

SAFETY PROFILE ESTABLISHED IN Ps AND PsA 1 Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393270/

Long-Term Safety of Risankizumab in Patients with ... The results support the favourable safety profile of risankizumab for long-term treatment of psoriatic disease with no new safety concerns.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761262s000lbl.pdf

skyrizi - accessdata.fda.gov Data from placebo- and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the ...

9. skyrizi.com skyrizi.com/important-safety-information

Important Safety Information | SKYRIZI® (risankizumab-rzaa) The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include: upper respiratory infections, headache, joint pain ...

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

Safety Profile - SKYRIZI® (risankizumab-rzaa) for Crohn's Review the SKYRIZI® safety profile, including adverse events, for moderate to severe Crohn's disease in adults. See Important Safety, Prescribing Info.