Sonelokimab for Psoriatic Arthritis

Enrolling by invitation at 1 trial location
MC
Overseen ByMoonlake Clinical Trial Helpdesk
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: MoonLake Immunotherapeutics AG
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term effectiveness of a drug called sonelokimab for individuals with psoriatic arthritis, a condition where the immune system attacks the joints and skin. The goal is to determine if the drug is safe and effective in reducing symptoms like joint pain and skin issues. Participants will receive the medication via injection every four weeks. Those who recently completed a related study with sonelokimab and believe they might benefit from continued treatment may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to the potential availability of a new treatment option.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that ongoing or planned use of certain prohibited treatments for psoriatic arthritis or other conditions is not allowed. It's best to discuss your current medications with the trial team to see if they are permitted.

Is there any evidence suggesting that sonelokimab is likely to be safe for humans?

Research shows that sonelokimab appears safe for treating psoriatic arthritis. In earlier studies, participants tolerated sonelokimab well, and researchers found no unexpected safety issues. There were no cases of inflammatory bowel disease (IBD) or major heart problems. Only four participants experienced mild to moderate mouth issues, which were generally not serious.

Another study also reported good safety results, with no new concerns over time. This suggests that sonelokimab remains well tolerated by patients. Overall, the evidence so far indicates that sonelokimab is a safe option for those considering joining a clinical trial.12345

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

Sonelokimab is unique because it targets the IL-17A and IL-17F cytokines, which play a key role in the inflammation process of psoriatic arthritis. This dual-targeting approach is different from many existing treatments that typically focus on just one cytokine. Additionally, sonelokimab is administered subcutaneously every four weeks, offering a relatively convenient dosing schedule compared to some existing options. Researchers are excited about its potential to provide a more comprehensive control of inflammation with potentially fewer side effects.

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

Research has shown that sonelokimab may help treat psoriatic arthritis. In earlier studies, 48% of patients experienced significant improvement in joint and skin symptoms. By week 24, about 58% to 61% of patients reported significant relief in joint symptoms. These findings suggest that sonelokimab can effectively improve both skin and joint issues in people with psoriatic arthritis. Overall, this highlights sonelokimab as a promising treatment option for managing the condition.12346

Are You a Good Fit for This Trial?

This trial is for individuals with psoriatic arthritis who completed a prior study and can potentially benefit from continued treatment. They must have received their last dose in the previous study no more than 8 weeks ago. Women of childbearing age must agree to use contraception, and men must use condoms during the study and for 8 weeks after.

Inclusion Criteria

My doctor thinks I will benefit from this study.
I completed my last treatment and visit in the previous study.
I received my last study treatment less than 8 weeks ago.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sonelokimab 60 mg subcutaneously every 4 weeks

52 weeks
13 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 trial is testing the long-term safety, tolerability, and effectiveness of Sonelokimab when given subcutaneously (under the skin) to patients with psoriatic arthritis who were part of earlier phase trials.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experimental: sonelokimab doseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MoonLake Immunotherapeutics AG

Lead Sponsor

Trials
7
Recruited
2,800+

Citations

Sonelokimab for psoriatic arthritis: 24-week results from the ...

Sonelokimab achieved composite ACR70 + PASI100 in 48% of patients, demonstrating concurrent efficacy on high hurdle joint and skin outcomes.

Press releases

Response rates for sonelokimab 120mg were consistent between the two trials, with 34.8% and 35.9% of patients in VELA-1 and VELA-2 achieving ...

Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for ...

ACR50 response rates continued to improve through week 24 in patients receiving SLK, with 58.1–61.0% of patients randomized to SLK achieving an ...

POS0428 EFFECTS OF SONELOKIMAB, AN IL-17A- AND ...

The randomized, placebo-controlled Phase 2 ARGO trial in patients with active psoriatic arthritis (PsA) demonstrated the efficacy of sonelokimab on both joint ...

Efficacy and Safety of Sonelokimab, a Novel IL-17A- ...

Results: ACR50 response rates improved from W12 to W24 in patients receiving sonelokimab (60 mg: W24, 61% from W12, 46%; 120 mg: W24, 58% from W12, 47%; Figure ...

Study Details | NCT05640245 | Evaluation of Sonelokimab ...

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the ...