Risankizumab for Healthy Subjects

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests risankizumab, administered through an on-body injector, to study its absorption and utilization in the body. It aims to understand the differences between two production methods of the treatment. The trial seeks healthy adults who are generally fit, with a body weight between 40 kg and 100 kg, and a BMI (a measure of body fat based on height and weight) between 18 and 32. Participants should be in good health and must not have used similar treatments in the past year. 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 treatment.

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.

Is there any evidence suggesting that risankizumab is likely to be safe for humans?

Research has shown that risankizumab is generally safe for use. In long-term studies, most participants reported little to no impact on their daily activities, indicating that serious side effects are rare. Another study found only minor side effects and no major safety issues with long-term use, suggesting the medication's safety. Although this study is in its early stages and involves healthy adults, existing evidence from other conditions supports the safety of risankizumab. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Risankizumab is unique because it uses a monoclonal antibody to specifically target and block a protein called IL-23, which plays a key role in inflammatory processes. Unlike traditional treatments for autoimmune conditions, which might broadly suppress the immune system, Risankizumab focuses on this specific pathway, potentially reducing side effects and increasing effectiveness. Researchers are especially excited about the new delivery method being tested, the On-Body Injector (OBI), which could improve patient convenience and adherence compared to conventional injection methods.

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

Research has shown that risankizumab is highly effective for treating conditions like psoriasis. In one study, 98.7% of patients experienced a significant reduction in their symptoms, with a 75% improvement in their Psoriasis Area and Severity Index, which measures the severity of psoriasis. Another study found that most patients maintained clear or nearly clear skin after a year of treatment. Risankizumab also proves effective for individuals with Crohn's disease, with real-world evidence indicating it benefits those who have tried other treatments. Overall, these findings suggest risankizumab can be a strong option for managing these conditions.

In this trial, healthy participants will receive a single dose of risankizumab via an On-Body Injector (OBI). One group will receive it produced by a new process, while another group will receive it produced by the current process. ^{1 2 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12436474/

Long-Term Safety and Efficacy of Risankizumab to Treat ... During the base studies, risankizumab treatment demonstrated high rates of rapid and durable efficacy through 52 weeks; risankizumab treatment ...

2. 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

Digestive Diseases Researchers shared real-world effectiveness data and demonstrated how RZB performs in patients with prior therapy exposure and other ...

3. 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 ...

4. link.springer.com link.springer.com/article/10.1007/s13555-025-01342-0

Real-World Effectiveness of Risankizumab in Patients with ... In this prospective study, risankizumab demonstrated higher effectiveness, longer drug survival, and better improvement of patient-reported outcomes at 25 ...

5. medicaljournalssweden.se medicaljournalssweden.se/actadv/article/view/283/1164

View of Real-life Effectiveness and Safety of Risankizumab ... At week 40, 98.7%, 85.7% and 62.3% of patients achieved a Psoriasis Area and Severity Index (PASI) reduction ≥ 75% (PASI 75), PASI 90 and PASI 100, respectively ...

6. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/jcph.1473

Pharmacokinetics of Risankizumab in Asian Healthy Subjects ... Risankizumab exposures were approximately 20% to 30% higher in Japanese and Chinese healthy subjects compared with white healthy subjects or in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02986373

NCT02986373 | A Study to Investigate Safety With ... This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).

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

Long-Term Safety and Efficacy of Risankizumab to Treat ... Overall, there were minimal side effects with risankizumab treatment and no safety concerns with long-term use.