Risankizumab for Healthy Participants

No longer recruiting at 1 trial location

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

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

Disqualifiers: Strenuous exercise, 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: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the body processes Risankizumab, administered either through an IV (a drip into a vein) or as a shot under the skin. Researchers aim to compare these two methods of administration. The trial seeks healthy participants with a body weight between 40 kg and 100 kg and a body mass index (BMI) between 18 and 32, who have not recently taken similar medications. Participants should not plan to start any intense new exercise routines during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I need to stop my current medications to join 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?

Previous studies have shown that risankizumab is generally safe. For both intravenous (IV) infusion and subcutaneous (SC) injection, common side effects include colds, headaches, and joint pain. These side effects occurred in more than 1% of people treated for conditions like Crohn's disease and plaque psoriasis. Research shows that these side effects usually appear during the first 16 weeks of treatment and remain consistent over longer periods, up to 52 weeks. This indicates the treatment is generally well-tolerated over time. However, individual experiences can vary, so discussing with a healthcare provider can provide more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Risankizumab is unique because it targets interleukin-23 (IL-23), a protein that plays a key role in inflammatory processes. Unlike standard treatments that might target a broader range of immune responses, risankizumab's focus on IL-23 allows for a more precise intervention, potentially leading to fewer side effects and improved efficacy. Additionally, this trial explores two delivery methods—intravenous infusion and subcutaneous injection—offering flexibility and convenience that could enhance patient experience. Researchers are particularly excited about the potential for these targeted therapies to provide more effective and personalized treatment options.

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

Research has shown that risankizumab effectively treats conditions like plaque psoriasis and ulcerative colitis. For plaque psoriasis, studies found that 81% to 82% of patients experienced significant improvement after one year, with 60% achieving clear skin. In ulcerative colitis, more patients on risankizumab went into remission compared to those on a placebo. Additionally, patients with Crohn's disease showed noticeable improvement after 12 weeks of treatment. These findings suggest that risankizumab is effective for several inflammatory conditions. In this trial, participants will receive either Risankizumab Dose A for intravenous infusion or Risankizumab Dose B for subcutaneous injection to evaluate its effects in healthy participants. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study comparing two ways of receiving Risankizumab, a medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

My weight is between 40 kg and 100 kg.

My overall health is good based on recent medical exams.

My BMI is between 18.0 and 32.0.

Exclusion Criteria

Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

I have been treated with anti-IL-12/23 or anti-IL-23 drugs for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous or subcutaneous administration of Risankizumab

4 weeks

Follow-up

Participants are monitored for safety and pharmacokinetic outcomes after treatment

140 days

What Are the Treatments Tested in This Trial?

Interventions

• Risankizumab

Trial Overview The focus of this trial is on how the body absorbs Risankizumab when it's given through an IV (intravenous) versus as a shot under the skin (subcutaneous). The goal is to understand differences in drug levels in the bloodstream with these methods.

How Is the Trial Designed?

Group I: Risankizumab Dose B for Subcutaneous (SC) Injection Experimental Treatment 1 Intervention

Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.

Group II: Risankizumab Dose A for Intravenous (IV) Infusion Experimental Treatment 1 Intervention

Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9455321/

Real-life Effectiveness and Safety of Risankizumab in ... These data suggest that the efficacy of risankizumab for plaque psoriasis in “real-life” clinical practice could differ from pivotal clinical trials data.

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. news.abbvie.com news.abbvie.com/2023-06-15-Risankizumab-SKYRIZI-R-Met-Primary-and-Key-Secondary-Endpoints-in-52-Week-Phase-3-Maintenance-Study-in-Ulcerative-Colitis-Patients

Risankizumab (SKYRIZI®) Met Primary and Key ... A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved clinical remission at week 52: 40% and 38%, ...

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

Risankizumab for Ulcerative Colitis: Two Randomized ... At week 12, risankizumab significantly improved clinical remission rates compared with placebo (20.3% vs 6.2%, respectively; adjusted between- ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03105128

NCT03105128 | A Study of the Efficacy and Safety ... The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to ...

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

Safety Profile - SKYRIZI® (risankizumab-rzaa) for Crohn's Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, ...

7. 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 ...

8. rxabbvie.com rxabbvie.com/pdf/skyrizi_pi.pdf

skyrizi_pi.pdf Long-term safety up to 52 weeks was evaluated in subjects who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance study ...

9. 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 ...

10. 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 ...