Sonelokimab for Psoriatic Arthritis
(IZAR-1 Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: MoonLake Immunotherapeutics AG
Must not be taking: Biologics
Disqualifiers: Inflammatory bowel disease, Arthritis mutilans, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have used biologic treatments for psoriatic arthritis before.
What evidence supports the effectiveness of the drug Sonelokimab for treating psoriatic arthritis?
Sonelokimab, which targets both IL-17A and IL-17F, has shown promising results in early studies for psoriasis, and similar dual-targeting drugs like bimekizumab have demonstrated effectiveness in treating psoriatic arthritis. This suggests that Sonelokimab may also be effective for psoriatic arthritis.12345
What is known about the safety of Sonelokimab in humans?
How is the drug Sonelokimab different from other treatments for psoriatic arthritis?
Sonelokimab is unique because it is a trivalent nanobody that targets both IL-17A and IL-17F, which are proteins involved in inflammation, using a novel approach derived from camelid antibodies. This dual targeting could potentially offer better disease control compared to treatments that only target one of these proteins.13789
Eligibility Criteria
This trial is for adults over 18 with active psoriatic arthritis who haven't used biologic disease-modifying antirheumatic drugs. They must have a confirmed diagnosis, at least 3 tender and swollen joints, and current or past plaque psoriasis but can't test positive for rheumatoid factor or anti-cyclic citrullinated peptide.Inclusion Criteria
I currently have plaque psoriasis or a doctor has confirmed I've had it before.
Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit
I have been diagnosed with psoriatic arthritis for at least 6 months.
See 2 more
Exclusion Criteria
I have a chronic inflammatory condition, but it's not psoriasis or psoriatic arthritis.
Participants with a known hypersensitivity to sonelokimab or any of its excipients
I have been diagnosed with inflammatory bowel disease.
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive sonelokimab or placebo subcutaneously, with some receiving an induction regimen followed by maintenance dosing every 4 weeks
16 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Sonelokimab (Monoclonal Antibodies)
Trial OverviewThe study tests the effectiveness and safety of sonelokimab versus a placebo in treating psoriatic arthritis. Sonelokimab is given as an injection under the skin to patients who are new to biological treatments.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: sonelokimab dose without an induction regimenExperimental Treatment1 Intervention
Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.
Group II: sonelokimab dose with an induction regimenExperimental Treatment1 Intervention
Subjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8.
Group III: PlaceboPlacebo Group1 Intervention
Subjects randomized to this arm will receive placebo subcutaneously.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical SiteUpland, CA
Clinical SiteGrapevine, TX
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Who Is Running the Clinical Trial?
MoonLake Immunotherapeutics AGLead Sponsor
References
Dual inhibition of IL-17A and IL-17F in psoriatic disease. [2021]Psoriasis and psoriatic arthritis are chronic immune-mediated disorders with involvement of interleukin (IL)-17 cytokines in their pathogenesis. IL-17A has been considered to be the most biologically active, but IL-17F is also over-expressed in skin and synovial tissues of patients with these diseases. Many therapeutic advances have been made in the past years, but some needs remain unmet. Dual inhibitor and bispecific antibodies simultaneously targeting IL-17A and IL-17F could provide better disease control. Herein we review current evidence on bimekizumab and sonelokimab. The antigen-binding site of bimekizumab neutralizes both IL-17A and IL-17F; phase I, II, and III studies have demonstrated its efficacy and safety in psoriasis and psoriatic arthritis. Sonelokimab is a trivalent nanobody targeting IL-17A and IL-17F; phase I and II studies with this molecule have yielded promising results in psoriasis.
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]To assess the safety and efficacy of ixekizumab, a monoclonal antibody that inhibits interleukin-17A, in a double-blind phase III trial enrolling patients with active psoriatic arthritis (PsA).
Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. [2020]Dual neutralisation of interleukin 17A (IL17A) and interleukin 17F (IL17F) is a potential novel therapeutic approach in psoriatic arthritis. We assessed bimekizumab, a monoclonal antibody that selectively neutralises IL17A and IL17F, in patients with active psoriatic arthritis.
Efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriatic arthritis: a 24-week, randomised, double-blind, placebo-controlled, phase II proof-of-concept trial. [2022]To evaluate the efficacy and safety of secukinumab, a fully human, anti-interleukin (IL)-17A monoclonal antibody, in patients with psoriatic arthritis (PsA).
An Overview of Bimekizumab for the Treatment of Psoriatic Arthritis: The Evidence so Far. [2023]Psoriatic arthritis is a complex and heterogeneous disease with potential significant disability and impaired quality of life. Although in the last decades new treatment options have led to a better management of this disease, there are still significant unmet therapeutic needs. Dual inhibitor antibodies target two different cytokines simultaneously, potentially offering a better disease control. In psoriatic arthritis, there is evidence for a pathogenic role not only of IL-17A but also the structurally homologous IL-17F. It is postulated that differential expression of both in several targets of PsA could account for disparities in clinical response to IL-17A inhibition alone (such as with secukinumab or ixekizumab). Here we review the evidence so far for the use in psoriatic arthritis of bimekizumab, the first humanized monoclonal IgG1 antibody that selectively neutralizes both IL-17A and IL-17F. A Phase 2b trial reports better outcomes over both placebo and IL-17A inhibition alone. Very recently encouraging results from open-label extensions with regards to both safety and maintenance of response were presented. Phase III trials are ongoing with the first results awaited in 2021.
Brodalumab: A Review of Safety. [2019]Interleukin (IL)-17 is important in the pathophysiology of psoriasis and has proven to be an effective therapeutic target. Brodalumab, the third commercially available IL-17 antagonist, was approved by the US FDA in February 2017 for the treatment of moderate-tosevere plaque psoriasis. As brodalumab enters the marketplace, it is imperative to investigate its safety profile. We conducted a safety assessment of brodalumab using publically available adverse event data from phase II and III clinical trials. The most common adverse events were nasopharyngitis, upper respiratory tract infection, and candidiasis. The FDA issued a black box warning after six patients treated with brodalumab across four clinical trials committed suicide, but no causal relationship was identified. Current evidence suggests a similar safety profile for brodalumab compared to other IL-17 antagonists used to treat moderate-to-severe plaque psoriasis.
IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. [2022]Sonelokimab (also known as M1095) is a novel trivalent nanobody comprised of monovalent camelid-derived (ie, from the Camelidae family of mammals, such as camels, llamas, and alpacas) nanobodies specific to human interleukin (IL)-17A, IL-17F, and human serum albumin. Nanobodies are a novel class of proprietary therapeutic proteins based on single-domain, camelid, heavy-chain-only antibodies. We assessed the efficacy, safety, and tolerability of sonelokimab across four dosage regimens compared with placebo in patients with plaque-type psoriasis. Secukinumab served as an active control.
Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. [2022]Secukinumab, a fully human antiinterleukin 17A monoclonal antibody, is efficacious for the treatment of psoriatic arthritis (PsA) and ankylosing spondylitis (AS). This study examined the immunogenicity of secukinumab in patients with PsA and AS exposed to secukinumab for up to 52 weeks.
Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study. [2021]Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications.