What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis, particularly IL-17A inhibitors like secukinumab and ixekizumab, are generally well-tolerated but can have side effects such as nasopharyngitis, headache, and injection site reactions. Other treatments, such as TNF inhibitors (e.g., adalimumab, etanercept, infliximab), may cause infections, injection site reactions, and potential malignancy risks. Methotrexate, another common treatment, can lead to gastrointestinal distress, hepatotoxicity, hematologic toxicity, and pulmonary toxicity. Regular monitoring is essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Psoriatic Arthritis (PsA) that target interleukin pathways, similar to Izokibep, which inhibits IL-17A. Notable among these are Secukinumab and Ixekizumab, both of which are IL-17A inhibitors. Additionally, Ustekinumab, which targets IL-12/23, has also been approved for PsA. These biologics have shown efficacy in reducing symptoms and improving quality of life for patients with PsA.

What other types of research exist?

Promising alternatives to Izokibep for Psoriatic Arthritis patients include: <ol> <li>Secukinumab: An IL-17A inhibitor that has shown significant improvement in joint and skin symptoms, physical function, and quality of life.</li> <li></li> </ol> Ixekizumab: Another IL-17A inhibitor with demonstrated efficacy in plaque psoriasis and PsA. 3. Guselkumab: An IL-23 inhibitor that has shown efficacy and safety in PsA patients. 4. Upadacitinib: A Janus kinase (JAK) inhibitor that has shown efficacy in patients with active ankylosing spondylitis and PsA. These treatments offer alternative mechanisms of action and have demonstrated clinical benefits in PsA management.

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Interleukin-17A Inhibitor

Izokibep for Psoriatic Arthritis

Phase 2 & 3

Waitlist Available

Research Sponsored by ACELYRIN Inc.

Eligibility Criteria Checklist

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

Must have

Active PsA defined as ≥3 tender joints (based on 68 joint counts) and ≥3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits

Subject must have had an inadequate response to at least one of the following: nonsteroidal anti-inflammatory drug (NSAID), conventional-synthetic disease-modifying anti-rheumatic drugs (csDMARD) (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A), tumor necrosis factor-alpha inhibitor(s) (TNFi) (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab).

Must not have

Uncontrolled, clinically significant system disease

History of fibromyalgia, or any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new drug called izokibep for people with psoriatic arthritis. Izokibep aims to reduce inflammation by blocking a protein that causes joint and skin problems.

Who is the study for?

Adults aged 18-75 with psoriatic arthritis diagnosed at least 6 months ago, who haven't responded well to certain drugs like NSAIDs or TNF inhibitors. They must not have severe depression, active infections, inflammatory bowel disease, fibromyalgia, other types of arthritis diagnosed before age 17, uncontrolled diseases, TB or fungal infections in recent chest x-rays, HIV positive status or a history of cancer within the last five years.

What is being tested?

The trial is testing Izokibep's effectiveness for treating psoriatic arthritis compared to a placebo. Izokibep is designed to block interleukin (IL)-17A which plays a role in inflammation and is believed to contribute to PsA symptoms.

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as increased risk of infection. Specific side effects are not listed but could be similar to those seen with other IL-17A inhibitors like injection site reactions or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I have active Psoriatic Arthritis with at least 3 tender and 3 swollen joints.

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I have tried at least one common arthritis treatment without enough improvement.

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I am between 18 and 75 years old and can legally consent.

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I have never had active tuberculosis.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious illness that is not under control.

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I have had fibromyalgia, arthritis before 17, or have inflammatory joint disease (not PsA).

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I have or might have inflammatory bowel disease, indicated by high fecal calprotectin levels.

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I do not have severe depression or similar conditions that are not under control.

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I currently have an infection or have had serious infections in the past.

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I have HIV or tested positive for HIV.

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I was diagnosed with cancer within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4Experimental Treatment2 Interventions

Izokibep Dose 3 from Day 1/Week 0 to Week 51

Group II: Group 3Experimental Treatment2 Interventions

Izokibep Dose 2 from Day 1/Week 0 to Week 51

Group III: Group 2Experimental Treatment1 Intervention

Izokibep Dose 1 from Day 1/Week 0 to Week 51

Group IV: Group 1Experimental Treatment2 Interventions

Placebo from Day 1/Week 0 to Week 15, then izokibep from Week 16 to Week 51

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Izokibep

2022

Completed Phase 2

~220

Placebo to izokibep

2022

Completed Phase 2

~210

0 / 12Eligibility 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 Psoriatic Arthritis (PsA) include biologic agents that target specific components of the immune system to reduce inflammation and halt disease progression. Inhibitors of interleukin (IL)-17A, such as secukinumab and ixekizumab, block the action of IL-17A, a cytokine involved in the inflammatory response seen in PsA. Similarly, IL-23 inhibitors like ustekinumab and guselkumab target the IL-23/Th17 pathway, which is crucial for the production of IL-17A and other pro-inflammatory cytokines. Tumor necrosis factor (TNF) inhibitors, such as infliximab and adalimumab, block TNF, another key cytokine in the inflammatory process. These treatments are important for PsA patients as they help to control both joint inflammation and skin lesions, improving overall quality of life and preventing long-term joint damage.

Find a Location

Who is running the clinical trial?

ACELYRIN Inc.Lead Sponsor

8 Previous Clinical Trials

748 Total Patients Enrolled

1 Trials studying Psoriatic Arthritis

129 Patients Enrolled for Psoriatic Arthritis

Myreen Tomas, MDStudy DirectorACELYRIN Inc.

1 Previous Clinical Trials

129 Total Patients Enrolled

1 Trials studying Psoriatic Arthritis

129 Patients Enrolled for Psoriatic Arthritis

Apinya Lert, MDStudy DirectorACELYRIN Inc.

1 Previous Clinical Trials

129 Total Patients Enrolled

1 Trials studying Psoriatic Arthritis

129 Patients Enrolled for Psoriatic Arthritis

Media Library

Izokibep (Interleukin-17A Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05623345 — Phase 2 & 3

Psoriatic Arthritis Research Study Groups: Group 3, Group 4, Group 1, Group 2

Psoriatic Arthritis Clinical Trial 2023: Izokibep Highlights & Side Effects. Trial Name: NCT05623345 — Phase 2 & 3

Izokibep (Interleukin-17A Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05623345 — Phase 2 & 3

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