Izokibep for Psoriatic Arthritis

No longer recruiting at 103 trial locations

Overseen By Apinya Lert, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: ACELYRIN Inc.

Disqualifiers: Inflammatory bowel disease, Fibromyalgia, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 51 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called izokibep for psoriatic arthritis, a painful condition that causes swollen and stiff joints. The goal is to determine how effectively izokibep reduces these symptoms. Participants will receive varying doses of the medication to identify the most effective one. Ideal candidates are those who have experienced psoriatic arthritis symptoms for at least six months and have not found relief with other treatments like NSAIDs or certain arthritis drugs. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify that you must stop taking your current medications. However, if you are using certain medications like methotrexate, leflunomide, or corticosteroids, you need to be on a stable dose for a specified period before starting the study drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that izokibep is generally safe for people with psoriatic arthritis. In earlier studies, patients using izokibep experienced significantly better symptom relief compared to those taking a placebo, a harmless pill with no active medicine. These studies also found similar side effects between the izokibep and placebo groups, indicating no major safety issues.

Izokibep works by blocking a protein called IL-17A, which causes inflammation. This treatment has been tested for over a year, yielding positive results for both safety and effectiveness. While some patients might experience minor side effects, the overall evidence supports the safety of izokibep in treating psoriatic arthritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriatic arthritis?

Researchers are excited about izokibep for psoriatic arthritis because it offers a new approach by targeting interleukin-17A, a key player in inflammation, with high specificity. Unlike existing treatments like TNF inhibitors and IL-12/23 blockers, izokibep's smaller molecular size potentially allows for better tissue penetration and effectiveness. Additionally, its unique design may result in fewer side effects and a more convenient dosing schedule, making it a promising option for those seeking better control of their symptoms.

What evidence suggests that izokibep might be an effective treatment for psoriatic arthritis?

Research has shown that izokibep holds promise for treating psoriatic arthritis (PsA). By week 52 in studies, about half of the patients experienced a 50% improvement in their symptoms. In this trial, participants will receive different doses of izokibep, with some initially receiving a placebo before switching to izokibep. Those who received izokibep showed noticeable improvements in various aspects of PsA compared to the placebo group. Early data indicates that many patients achieved low disease activity by week 4, with further improvements over time. Overall, these results suggest that izokibep could effectively manage PsA symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

Shepard Mpofu, MD, Clinical Development

Principal Investigator

ACELYRIN Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with psoriatic arthritis for at least 6 months and meet the CASPAR criteria.

I have been on a stable dose of corticosteroids, not exceeding 7.5 mg of prednisone daily, for at least 4 weeks.

Your blood test results for rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) are negative.

Exclusion Criteria

I have a serious illness that is not under control.

My arthritis pain might affect my participation in the study.

I don't have any health conditions that could risk my safety in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or izokibep for up to 51 weeks, with placebo participants switching to izokibep at Week 16

51 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Izokibep

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 4 Experimental Treatment 2 Interventions

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

Group II: Group 3 Experimental Treatment 2 Interventions

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

Group III: Group 2 Experimental Treatment 1 Intervention

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

Group IV: Group 1 Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

ACELYRIN Inc.

Lead Sponsor

Trials

9

Recruited

1,100+

Published Research Related to This Trial

Bimekizumab (BKZ) demonstrated sustained efficacy in treating active psoriatic arthritis (PsA) from Week 16 to Week 52, maintaining significant improvements in ACR response criteria and psoriasis severity measures.

The treatment was well tolerated, with a similar rate of treatment-emergent adverse events (TEAEs) compared to adalimumab, and no new safety concerns were identified, although localized Candida infections were noted in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ritchlin, CT., Coates, LC., McInnes, IB., et al.[2023]

In a phase III trial with 417 patients suffering from active psoriatic arthritis, ixekizumab significantly improved disease activity, with 62.1% of patients on the 80 mg every 2 weeks regimen achieving an ACR20 response compared to only 30.2% in the placebo group.

While ixekizumab showed efficacy in reducing disease symptoms and preventing structural damage, it also had a higher rate of treatment-emergent adverse events (65.7-66.4%) compared to placebo (47.2%), indicating a need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Mease, PJ., van der Heijde, D., Ritchlin, CT., et al.[2022]

Ixekizumab, a monoclonal antibody targeting IL-17A, has shown superior efficacy compared to etanercept and ustekinumab in treating moderate-to-severe plaque psoriasis, and comparable efficacy to adalimumab in psoriatic arthritis, based on long-term Phase III studies.

The safety profile of ixekizumab is generally tolerable, similar to other biologics, but requires monitoring for non-invasive Candida infections and caution in patients with inflammatory bowel disease due to potential exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab for the treatment of psoriasis: an update on new data since first approval. Blegvad, C., Skov, L., Zachariae, C.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0003496725008155

Psoriatic arthritis Efficacy and safety of izokibep in patients ... For DAPSA, low disease activity (≤14) was reached in 21% and 23% of patients treated with izokibep 80 and 40 mg, respectively, at week 4 and improved to 45% and ...

2. affibody.se affibody.se/press/positive-52-week-phase-2b-3-data-of-izokibep-in-psoriatic-arthritis-to-be-presented-at-acr-convergence-2025/

Positive 52-week Phase 2b/3 Data of Izokibep in Psoriatic ... By week 52, approximately half of all patients achieved ACR50 (izokibep Q2W: 50%, izokibep QW: 57%, placebo-izokibep QW: 51%). Substantial ...

3. firstwordpharma.com firstwordpharma.com/story/6511666

Novel IL-17a inhibitor delivers strong, durable results in ... Izokibep demonstrated durable efficacy across multiple psoriatic arthritis domains. By week 52, roughly half of patients achieved ACR50 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40455082/

Efficacy and safety of izokibep in patients with active ... Conclusions: Izokibep resulted in significant and clinically meaningful improvements over placebo across multiple disease domains, and the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05623345

NCT05623345 | Psoriatic Arthritis Study of Izokibep Number of Participants Achieving 20% Improvement in ACR (ACR20) at Week 16, ACR20 is a clinical trial measure for PsA, indicating a 20% improvement in symptoms.

6. ard.bmj.com ard.bmj.com/content/83/Suppl_1/235

LBA0005 EFFICACY AND SAFETY OF IZOKIBEP, A ... Izokibep (IZO) is a small protein therapeutic (18.6 kDa) designed to selectively inhibit IL-17A with high potency through tight binding affinity.