Risankizumab Administration Methods for Healthy Subjects

Not currently recruiting at 1 trial location

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 via injection, to evaluate its absorption and safety. Researchers aim to compare two delivery methods: a prefilled syringe and a prefilled pen. The trial targets healthy adults with a BMI between 18.0 and 32.0 and a weight between 40 kg and 100 kg. Participants must be in good overall health and should not have taken 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.

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 shows that risankizumab, the treatment under study, is generally well-tolerated. Earlier studies identified mild side effects as the most common, including colds, headaches, fatigue, and injection site reactions.

However, some individuals have experienced serious allergic reactions. In such cases, it is crucial to discontinue the treatment and seek emergency assistance immediately. Despite these risks, risankizumab has approval for other conditions, indicating a well-understood safety profile. This information may reassure those considering participation in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different administration methods for risankizumab because they could make treatment more convenient for patients. Risankizumab is typically used for conditions like plaque psoriasis and works by targeting and blocking a specific protein involved in inflammation. Unlike other treatments that might require more frequent dosing or a clinic visit, the use of a prefilled syringe or pen for a single subcutaneous injection could simplify the process, potentially improving patient compliance and overall experience. By testing these methods, researchers hope to find out which is more effective or preferred by patients, possibly leading to better outcomes and easier management of the condition.

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

Studies have shown that risankizumab effectively treats conditions like Crohn's disease and psoriasis. Specifically, patients with Crohn's disease taking risankizumab experienced significant improvements, with many achieving remission by week 52. In psoriasis treatment, patients observed meaningful skin improvements. Research indicates that risankizumab is generally safe, with similar safety profiles for both prefilled syringes and pens. This trial will compare different administration methods of risankizumab in healthy subjects, using prefilled syringes in one arm and prefilled pens in another. These findings suggest that risankizumab could be a promising option for managing these conditions. ^{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 adults with a BMI between 18.0 and 32.0, weighing between 40 kg and 100 kg. Participants must 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.

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

My weight is between 40 kg and 100 kg.

Exclusion Criteria

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

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.

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 injection of risankizumab via prefilled syringe or pen on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, safety, and tolerability of risankizumab

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Risankizumab

Trial Overview The study is testing the drug Risankizumab given through a prefilled pen versus a prefilled syringe to compare how the body absorbs it (bioavailability), its safety profile, immune response it may cause (immunogenicity), and overall tolerability.

How Is the Trial Designed?

Group I: Risankizumab Arm B Experimental Treatment 1 Intervention

Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose B administered via Prefilled Pen (PFP) at Day 1

Group II: Risankizumab Arm A Experimental Treatment 1 Intervention

Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at 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. 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. aContinuous placebo ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10777435/

Risankizumab: Mechanism of action, clinical and ... Efficacy data in the global phase III pivotal studies for treatment of PsO demonstrated that participants treated with risankizumab experienced ...

3. 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 ...

4. 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%, ...

5. 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 ...

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

Important Safety Information | SKYRIZI® (risankizumab-rzaa) SKYRIZI is a prescription medicine that may cause serious side effects, including: Serious allergic reactions: Stop using SKYRIZI and get emergency medical ...

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

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

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

skyrizi - accessdata.fda.gov WARNINGS AND PRECAUTIONS. • Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur (5.1).

9. ema.europa.eu ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf

Skyrizi, INN-Risankizumab - European Medicines Agency The recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4, and every 12 weeks thereafter (either as two 75 mg pre-filled syringe ...

10. skyrizihcp.com skyrizihcp.com/gastroenterology/ulcerative-colitis/safety

Safety Profile - SKYRIZI® (risankizumab-rzaa) for UC In Ps and PsA, the most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions ...