Sonelokimab for Psoriatic Arthritis

(IZAR-1 Trial)

Recruiting at 140 trial locations

Overseen By Moonlake Clinical Trial Helpdesk

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: MoonLake Immunotherapeutics AG

Must not be taking: Biologics

Disqualifiers: Inflammatory bowel disease, Arthritis mutilans, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

960 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of sonelokimab, a new injectable treatment for individuals with active psoriatic arthritis. Psoriatic arthritis causes joint pain and swelling along with skin symptoms. The study compares sonelokimab to a placebo (a substance with no active treatment) to evaluate its efficacy. Individuals with psoriatic arthritis symptoms for at least six months who have not previously used biologic treatments may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

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.

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

Research has shown that sonelokimab, a treatment targeting specific proteins in the immune system, was safe in earlier studies. In psoriasis trials, patients tolerated it well, and many experienced clear improvements in their skin. Another study involving multiple doses of sonelokimab also confirmed its safety. These findings suggest that sonelokimab is generally well-tolerated, with few side effects reported. However, individual experiences may vary with any treatment. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for psoriatic arthritis?

Sonelokimab is unique because it targets interleukin-17A and interleukin-17F, which are proteins involved in the inflammation process of psoriatic arthritis. Unlike traditional treatments like methotrexate or TNF inhibitors, which can have broader immune-suppressing effects, sonelokimab offers a more targeted approach that may reduce inflammation with potentially fewer side effects. Researchers are excited about sonelokimab because, in addition to its novel mechanism of action, it is administered subcutaneously, which is generally more convenient and less invasive than intravenous treatments. This targeted and convenient approach holds promise for improving the quality of life for people with psoriatic arthritis.

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

Research shows that sonelokimab holds promise for treating psoriatic arthritis. In this trial, participants will be randomized into different arms. Some will receive sonelokimab subcutaneously as an induction regimen followed by maintenance dosing, while others will receive sonelokimab without an induction regimen. Earlier studies demonstrated that patients taking sonelokimab experienced significant improvements, such as better joint movement and less skin irritation compared to those taking a placebo. Sonelokimab blocks certain proteins that cause inflammation. This dual action may reduce the symptoms of psoriatic arthritis more effectively. Early results suggest that patients experience notable relief, making it a hopeful option for those with this condition. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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

Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit

I currently have plaque psoriasis or a doctor has confirmed I've had it before.

I have been diagnosed with psoriatic arthritis for at least 6 months.

Exclusion Criteria

Participants with a known hypersensitivity to sonelokimab or any of its excipients

I have a chronic inflammatory condition, but it's not psoriasis or psoriatic arthritis.

I have been diagnosed with inflammatory bowel disease.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sonelokimab

Trial Overview The 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.

How Is the Trial Designed?

Group I: sonelokimab dose without an induction regimen Experimental Treatment 1 Intervention

Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.

Group II: sonelokimab dose with an induction regimen Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Subjects randomized to this arm will receive placebo subcutaneously.

Who Is Running the Clinical Trial?

MoonLake Immunotherapeutics AG

Lead Sponsor

Trials

7

Recruited

2,800+

Published Research Related to This Trial

Bimekizumab, a dual inhibitor targeting both IL-17A and IL-17F, has shown efficacy and safety in treating psoriasis and psoriatic arthritis across multiple phases of clinical trials (I, II, and III).

Sonelokimab, a trivalent nanobody also targeting IL-17A and IL-17F, has demonstrated promising results in early phase studies for psoriasis, indicating potential for effective treatment options in these chronic immune-mediated disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual inhibition of IL-17A and IL-17F in psoriatic disease. Iznardo, H., Puig, L.[2021]

In a phase 2b study involving 206 patients with active psoriatic arthritis, bimekizumab significantly improved symptoms compared to placebo, with higher response rates observed in the 16 mg and 160 mg dosage groups.

The safety profile of bimekizumab was acceptable, with most adverse events being mild or moderate, and no serious complications like deaths or inflammatory bowel disease reported, supporting further investigation in phase 3 trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Ritchlin, CT., Kavanaugh, A., Merola, JF., et al.[2020]

In a phase 2b trial involving 313 participants with moderate to severe plaque-type psoriasis, sonelokimab demonstrated significant efficacy, with 48.1% of patients in the 30 mg group and up to 88.2% in the 120 mg augmented load group achieving clear or almost clear skin (IGA score of 0 or 1) at week 12, compared to 0% in the placebo group.

Sonelokimab exhibited a safety profile comparable to secukinumab, with mostly mild to moderate adverse events, and a notable incidence of manageable Candida infections in the sonelokimab group, indicating it is a safe treatment option for psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Papp, KA., Weinberg, MA., Morris, A., et al.[2022]

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]

Secukinumab, a monoclonal antibody targeting interleukin-17A, has shown strong efficacy in treating moderate to severe psoriasis, psoriatic arthritis, and ankylosing spondylitis, with a favorable safety profile based on data from 2800 patients in the SERENA study.

The SERENA study, which includes patients who have been on secukinumab for an average of one year, aims to provide insights into the long-term effectiveness and safety of the treatment in real-world settings, confirming that the baseline demographics align with existing literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kiltz, U., Sfikakis, PP., Gaffney, K., et al.[2021]

Bimekizumab, a dual inhibitor antibody targeting both IL-17A and IL-17F, shows promising results in treating psoriatic arthritis, outperforming both placebo and treatments that inhibit IL-17A alone, based on a Phase 2b trial.

Early data from open-label extensions indicate that bimekizumab is safe and maintains its effectiveness, with Phase III trials currently underway to further evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Overview of Bimekizumab for the Treatment of Psoriatic Arthritis: The Evidence so Far. Oliveira, DG., Faria, R., Torres, T.[2023]

Brodalumab, an IL-17 antagonist approved for moderate-to-severe plaque psoriasis, has a safety profile similar to other IL-17 treatments, based on data from phase II and III clinical trials.

While common adverse events include nasopharyngitis and upper respiratory infections, a significant concern arose from six reported suicides among patients, leading to a black box warning, although no direct causal link was established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brodalumab: A Review of Safety. Rusta-Sallehy, S., Gooderham, M., Papp, K.[2019]

In a study involving 1414 patients with psoriatic arthritis (PsA) and 1164 patients with ankylosing spondylitis (AS), secukinumab demonstrated a very low incidence of treatment-emergent antidrug antibodies (TE-ADA), with only 0.35% in PsA and 0.69% in AS patients, indicating good immunogenicity safety.

The presence of TE-ADA did not affect the pharmacokinetics or efficacy of secukinumab, suggesting that the treatment remains effective even in patients who develop these antibodies, and no adverse events were linked to TE-ADA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. Deodhar, A., Gladman, DD., McInnes, IB., et al.[2022]

In a study of 42 patients with active psoriatic arthritis, secukinumab showed greater clinical responses and improvements in quality of life compared to placebo, particularly at weeks 12 and 24, despite not meeting the primary endpoint at week 6.

The safety profile of secukinumab was comparable to placebo, with a similar frequency of adverse events, indicating that it is a safe option for patients with psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. McInnes, IB., Sieper, J., Braun, J., et al.[2022]

Citations

1. ir.moonlaketx.com ir.moonlaketx.com/news-releases/news-release-details/moonlake-immunotherapeutics-announces-landmark-phase-2-results

Press Release MoonLake Immunotherapeutics announces landmark Phase 2 results for Nanobody® sonelokimab in active psoriatic arthritis.

2. the-rheumatologist.org the-rheumatologist.org/article/sonelokimab-promising-for-patients-with-psa/

Sonelokimab Promising for Patients with PsA Secondary end points included improvement in ACR20 response compared with placebo, complete skin clearance as measured by at least a PASI ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8366125/

Dual inhibition of IL-17A and IL-17F in psoriatic disease - PMC 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. Keywords ...

4. researchgate.net researchgate.net/publication/396239583_Sonelokimab_an_IL-17AIL-17F-inhibiting_nanobody_for_active_psoriatic_arthritis_a_randomized_placebo-controlled_phase_2_trial

(PDF) Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody ... Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial. October 2025 ...

5. trial.medpath.com trial.medpath.com/news/48d30c462ec9a9a8/moonlake-immunotherapeutics-advances-sonelokimab-through-phase-3-trials-for-multiple-inflammatory-conditions

MoonLake Immunotherapeutics Advances Sonelokimab ... MoonLake Immunotherapeutics is advancing Sonelokimab, a novel Nanobody® targeting IL-17A/A, A/F, and F/F dimers, through multiple Phase 3 trials for ...

6. ir.moonlaketx.com ir.moonlaketx.com/news-releases/news-release-details/moonlake-immunotherapeutics-announces-publication-lancet

MoonLake Immunotherapeutics announces publication in ... Sonelokimab showed significant clinical benefit with rapid onset and a good safety profile, with clear skin (PASI 100) achieved in up to 57% ...

7. jaad.org jaad.org/article/S0190-9622(19)30500-6/fulltext

A randomized, double-blind, placebo-controlled phase 1 ... Multiple subcutaneous doses of M1095 showed a favorable safety profile with dose-dependent improvements in psoriasis.

8. go.drugbank.com go.drugbank.com/drugs/DB18843

Sonelokimab: Uses, Interactions, Mechanism of Action Sonelokimab is under investigation in clinical trial NCT06411379 (Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared ...