Risankizumab Administration Methods in Healthy Adults

Not currently recruiting at 3 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Anti-IL-12/23, Anti-IL-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 examines how the body absorbs risankizumab when administered in two ways: through a prefilled syringe and an on-body injector, a wearable device that delivers the medication. The researchers aim to determine if one method is more effective or easier to use. Individuals who are generally healthy and have not previously used treatments targeting specific immune system proteins (anti-IL-12/23 or anti-IL-23) may be suitable candidates. This study is crucial for identifying the best delivery method for this medication in the future. 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 innovative 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. Please consult with the study coordinators for more details.

What prior data suggests that these administration methods for risankizumab are safe?

Previous studies have generally shown that risankizumab is well-tolerated. Safety data for the prefilled syringe reported no serious fungal infections or active tuberculosis cases. Although there were warnings about serious allergic reactions, these were rare.

For the on-body injector version, clinical trials found no new safety risks. Some patients experienced mild reactions at the injection site, but these were not serious. Serious allergic reactions, such as anaphylaxis, have been reported, but they remain uncommon.

Overall, both methods of administering risankizumab have been used safely in patients, with only a few rare serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Risankizumab because it offers innovative administration methods for delivering treatment. Unlike traditional psoriasis treatments that are typically administered through regular injections or oral medications, Risankizumab can be given via a prefilled syringe or an on-body injector, both delivering a subcutaneous dose. These new delivery options aim to enhance convenience and comfort for patients, potentially improving adherence to treatment. The on-body injector, in particular, represents a cutting-edge approach that allows for a more seamless and less hands-on experience.

What evidence suggests that this trial's administration methods for risankizumab could be effective?

Research has shown that risankizumab effectively treats conditions like Crohn's disease and psoriasis. One study found that most psoriasis patients experienced a 90% improvement in skin clearance, with some achieving completely clear skin after five years. For Crohn's disease, patients who responded to risankizumab continued to see improvements for a year. This trial will compare two administration methods of risankizumab: a prefilled syringe and a wearable injector. Specifically, when used with a wearable injector, risankizumab helped many patients maintain symptom control. These findings suggest that risankizumab, whether administered by a prefilled syringe or a wearable injector, holds promise for managing these conditions. ^{3 5 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. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose a risk.

Inclusion Criteria

My weight is between 40 kg and 100 kg.

Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters

A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria

Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement

I have been treated with IL-12/23 or IL-23 inhibitors 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 a single subcutaneous dose of Risankizumab via either a prefilled syringe or an on-body injector on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, bioavailability, and safety, including adverse events and anti-drug antibodies

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Risankizumab

Trial Overview The study is testing how risankizumab is absorbed and processed by the body when given through an on-body injector compared to a pre-filled syringe in healthy individuals.

How Is the Trial Designed?

Group I: Arm 2: Risankizumab On-Body Injector (OBI) Experimental Treatment 1 Intervention

Participants will receive a Subcutaneous (SC) single dose of Risankizumab OBI on Day 1

Group II: Arm 1: Risankizumab Prefilled Syringe (PFS) Experimental Treatment 1 Intervention

Participants will receive a Subcutaneous (SC) single dose of Risankizumab PFS 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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36917429/

Efficacy, Safety, Patient Experience, and Tolerability of ... Stable clinical remission was observed with both risankizumab doses. Two patients experienced injection site reactions; neither was related to ...

2. skyrizihcp.com skyrizihcp.com/gastroenterology/crohns-disease/efficacy

Efficacy Data - SKYRIZI® (risankizumab-rzaa) for Crohn's Results at 52 weeks are among 382 patients who achieved clinical response‡ after 12 weeks of treatment with SKYRIZI in induction trials. bContinuous placebo ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/03007995.2025.2506808

Patient-reported real-world experience of risankizumab on- ... Studies demonstrate that risankizumab has a significant impact on clinical disease activity and induces steroid-free remission in one-half of patients after 1 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0149291823004009

Clinical Bridging From Prefilled Syringe to On-body Injector ... This article describes the clinical development bridging strategy and key data to support the marketing application of the risankizumab on-body injection (OBI) ...

5. skyrizi.com skyrizi.com/crohns/skyrizi-results

Results With SKYRIZI® (risankizumab-rzaa) for Crohn's ... Results from 252 patients who achieved clinical response defined as a reduction in CDAI of at least 100 points from baseline after 12 weeks of treatment with ...

6. skyrizi.com skyrizi.com/skyrizi-complete/gastro/obi-support

Skyrizi On-Body Injector Support Find step-by-step video tutorials to learn how to inject SKYRIZI® (risankizumab‐rzaa) safely. See full Safety and Prescribing Information.

7. skyrizihcp.com skyrizihcp.com/gastroenterology/ulcerative-colitis/dosing/skyrizi-on-body-injector

On-Body Injector - SKYRIZI® (risankizumab-rzaa) for ... Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, ...

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

skyrizi_pi.pdf SKYRIZI is intended for use under the guidance and supervision of a healthcare professional. • Patients may self-inject SKYRIZI using the on-body injector with ...