Risankizumab for Healthy Subjects

Recruiting at 3 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: Strenuous exercise, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

252 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that you may not be on any regular medications.

What data supports the effectiveness of the drug Risankizumab?

Research shows that Risankizumab is effective in treating conditions like psoriasis and psoriatic arthritis, improving patient outcomes and quality of life. It has been tested in various trials, demonstrating its ability to manage these inflammatory diseases. ^{1 2 3 4 5}

Is risankizumab generally safe for humans?

Risankizumab has been studied for safety in conditions like psoriasis and Crohn's disease. Some serious side effects reported include infections, cancer, and heart issues, but these are not common. Overall, it has an acceptable safety profile, but more research is needed to understand rare side effects. ^{5 6 7 8 9}

How is the drug Risankizumab unique compared to other treatments?

Risankizumab is unique because it is a humanized monoclonal antibody that specifically targets the interleukin-23 (IL-23) protein, which plays a key role in inflammatory diseases like psoriasis and psoriatic arthritis. This targeted approach may offer a different mechanism of action compared to other treatments that do not specifically inhibit IL-23. ^{1 4 5 10 11}

What is the purpose of this trial?

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy adults with a BMI between 18.0 and 32.0, weighing more than 40 kg but less than 100 kg. Participants should be in good health as determined by medical history, physical exams, vital signs, lab tests, and an ECG.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

My weight is between 40 kg and 100 kg.

I am in good health overall, as confirmed by recent medical exams.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Risankizumab On-Body Injector on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics and adverse events

20 weeks

Treatment Details

Interventions

• Risankizumab

Trial Overview The study is testing the pharmacokinetics of Risankizumab when administered subcutaneously using an on-body injector to understand how the drug is absorbed and processed in the body.

Participant Groups

Group I: Risankizumab Arm B Experimental Treatment 1 Intervention

Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1.

Group II: Risankizumab Arm A Experimental Treatment 1 Intervention

Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1.

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 24-week Phase 3 trial involving patients with psoriatic arthritis who had inadequate responses to previous treatments, risankizumab (RZB) significantly improved patient-reported outcomes, including pain, fatigue, and overall health-related quality of life compared to placebo.

Patients treated with RZB reported better scores in multiple health assessments, including the SF-36 and FACIT-Fatigue, indicating enhanced ability to perform daily activities and work, demonstrating its efficacy in managing symptoms of psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. Ostor, AJK., Soliman, AM., Papp, KA., 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]

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]

Risankizumab, an anti-IL23 monoclonal antibody, demonstrated linear pharmacokinetics in patients with active psoriatic arthritis (PsA), with a favorable safety profile and robust efficacy when administered at a regimen of 150 mg subcutaneously at weeks 0, 4, and every 12 weeks thereafter.

The study analyzed data from 1527 participants across multiple clinical trials, confirming that the pharmacokinetics of risankizumab in PsA are comparable to those in patients with plaque psoriasis, with no significant impact of covariates on drug exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Thakre, N., D'Cunha, R., Goebel, A., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics of the Interleukin-23 Inhibitor Risankizumab in Subjects with Psoriasis and Crohn's Disease: Analyses of Phase I and II Trials. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Risankizumab for the Treatment of Moderate-to-Severe Psoriasis: Real-Life Multicenter Experience from the Czech Republic. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of Risankizumab in the Treatment of Psoriasis and Arthritic Psoriasis: Real-World Data from EudraVigilance Database. [2023]

6. 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]

7. Germany pubmed.ncbi.nlm.nih.gov

Risankizumab in real life: preliminary results of efficacy and safety in psoriasis during a 16-week period. [2022]

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. 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]

10. England pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. [2022]

11. Sweden pubmed.ncbi.nlm.nih.gov

Real-life Effectiveness and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis: A 40-week Multicentric Retrospective Study. [2022]