Izokibep for Psoriatic Arthritis
Recruiting at 94 trial locations
AL
Overseen ByApinya Lert, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: ACELYRIN Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
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.
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.
What data supports the effectiveness of the drug Izokibep for treating psoriatic arthritis?
How is the drug Izokibep different from other treatments for psoriatic arthritis?
Izokibep is unique because it is a small molecule that specifically targets and inhibits IL-17A, a protein involved in inflammation, with greater potency and efficacy than traditional monoclonal antibodies. Its small size allows it to distribute more effectively to sites of inflammation, potentially offering faster and more targeted relief for conditions like psoriatic arthritis.678910
Research Team
MT
Myreen Tomas, MD
Principal Investigator
ACELYRIN Inc.
Eligibility Criteria
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.
See 15 more
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.
See 8 more
Timeline
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
Treatment Details
Interventions
- Izokibep
Trial OverviewThe 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.
Participant Groups
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
ACELYRIN Inc.
Lead Sponsor
Trials
9
Recruited
1,100+
Findings from Research
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]
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]
References
Indirect comparisons of the efficacy of biological agents in patients with psoriatic arthritis with an inadequate response to traditional disease-modifying anti-rheumatic drugs or to non-steroidal anti-inflammatory drugs: A meta-analysis. [2022]
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. [2022]
Novel approaches to biological therapy for psoriatic arthritis. [2019]
Ustekinumab : targeting the IL-17 pathway to improve outcomes in psoriatic arthritis. [2015]
Changes in musculoskeletal disease activity and patient-reported outcomes in patients with psoriatic arthritis treated with ixekizumab: results from a real-world US cohort. [2023]
Apremilast efficacy and safety in a psoriatic arthritis patient affected by HIV and HBV virus infections. [2019]
Izokibep for the treatment of moderate-to-severe plaque psoriasis: a phase II, randomized, placebo-controlled, double-blind, dose-finding multicentre study including long-term treatment. [2023]
Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis. [2023]
Ixekizumab for the treatment of psoriasis: an update on new data since first approval. [2020]
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. [2023]
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