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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 day 1 to end of study; up to 65 weeks (±5 days)
Awards & highlights

Summary

This trial will test a new drug to treat psoriatic arthritis, an inflammatory joint condition.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~day 1 to end of study; up to 65 weeks (±5 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to end of study; up to 65 weeks (±5 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects achieving 50% improvement in American College of Rheumatology (ACR50)
Secondary outcome measures
Change in physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) change from baseline to Week 16
Incidence of clinically significant changes in laboratory values
Incidence of clinically significant changes in vital signs
+9 more

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
~190
Placebo to izokibep
2022
Completed Phase 2
~180

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
703 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
~132 spots leftby Jul 2025