What is the mechanism of action of this treatment?

The most common treatments for conditions studied in healthy subjects, such as IL-23 inhibitors like Risankizumab, work by targeting specific cytokines involved in inflammatory processes. IL-23 inhibitors block the action of interleukin-23, a cytokine that plays a crucial role in the inflammatory response and the maintenance of certain immune-mediated diseases. This inhibition helps reduce inflammation and modulate the immune system. For healthy subjects, understanding these mechanisms is important as it provides insights into the safety, efficacy, and potential side effects of these treatments, ensuring that they can be safely administered and monitored in clinical settings.

What side effects are associated with this type of intervention?

IL-23 inhibitors, such as risankizumab, are generally well-tolerated. Common side effects include hypersensitivity reactions and infections, though the risk of serious adverse events is not significantly different from placebo. Injection site reactions, such as erythema, pain, or bruising, are also reported. Other IL-23 inhibitors like ustekinumab and guselkumab share similar side effect profiles.

What prior FDA approvals exist?

Risankizumab, an IL-23 inhibitor, has been approved by the FDA for the treatment of moderate to severe Crohn's disease, psoriasis, and psoriatic arthritis. Other IL-23 inhibitors that have received FDA approval include guselkumab and tildrakizumab, which are also used for treating moderate to severe plaque psoriasis. These drugs work by targeting the p19 subunit of IL-23, similar to risankizumab, and have shown efficacy in managing autoimmune conditions.

What other types of research exist?

Promising novel alternatives to Risankizumab for patients in 2024 include ustekinumab, mirikizumab, brazikumab, and guselkumab. These agents have demonstrated efficacy and safety in clinical trials for conditions like ulcerative colitis, Crohn's disease, and psoriasis.

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Risankizumab Manufacturing Comparison for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight less than 100.00 kg at Screening and upon initial confinement.

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 141

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two different ways of making risankizumab, a medication that reduces inflammation by blocking a specific protein. It aims to see if the new manufacturing process works as well as the current one. Risankizumab is used for treating moderate to severe plaque psoriasis and other inflammatory diseases.

Who is the study for?

This trial is for healthy adults who weigh less than 100 kg and have a BMI between 18.0 to 32.0 kg/m2. Participants must pass a medical exam, including vital signs, lab tests, and an ECG to confirm good health.

What is being tested?

The study aims to compare the bioavailability of Risankizumab when made by two different manufacturing processes in healthy individuals after intravenous infusion.

What are the potential side effects?

As Risankizumab is being tested on healthy subjects, potential side effects may include allergic reactions, injection site reactions, headaches, fatigue or nausea but will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My weight is under 100 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 141

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 141

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 141 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC from Time 0 to Infinity (AUC0-inf)

Apparent Terminal Phase Elimination Rate Constant (β)

Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)

+4 more

Side effects data

From 2023 Phase 4 trial • 352 Patients • NCT04908475

14%

COVID-19

NASOPHARYNGITIS

HEADACHE

NAUSEA

UPPER RESPIRATORY TRACT INFECTION

DIARRHOEA

CORONARY ARTERY DISEASE

PROSTATE CANCER

100%

80%

60%

40%

20%

Study treatment Arm

Period B: APR/APR

Period A: APR

Period A: RZB

Period B: RZB/RZB

Period B: APR/RZB

Period B: APR/APR/RZB

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1Experimental Treatment1 Intervention

Participants will receive risankizumab manufactured with using the current process (CMC2).

Group II: Arm 2Active Control1 Intervention

Participants will receive risankizumab manufactured with using the new process (CMC3).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Risankizumab

2021

Completed Phase 4

~3340

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for conditions studied in healthy subjects, such as IL-23 inhibitors like Risankizumab, work by targeting specific cytokines involved in inflammatory processes. IL-23 inhibitors block the action of interleukin-23, a cytokine that plays a crucial role in the inflammatory response and the maintenance of certain immune-mediated diseases. This inhibition helps reduce inflammation and modulate the immune system. For healthy subjects, understanding these mechanisms is important as it provides insights into the safety, efficacy, and potential side effects of these treatments, ensuring that they can be safely administered and monitored in clinical settings.

Role of inflammatory cytokines in depression: Focus on interleukin-1β.IL-23 Blockade for Crohn s disease: next generation of anti-cytokine therapy.Cancer cachexia update in head and neck cancer: Pathophysiology and treatment.