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Monoclonal Antibodies

Sonelokimab for Psoriatic Arthritis (IZAR-1 Trial)

Phase 3

Recruiting

Research Sponsored by MoonLake Immunotherapeutics AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO

Participants must be ≥18 years of age

Must not have

Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA

Participants with a diagnosis of inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Pivotal Trial

Summary

This trial aims to show whether sonelokimab, given as a shot under the skin, is effective and safe in treating adults with active psoriatic arthritis who have not previously received biologic

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of sonelokimab aren't listed here, similar medications may cause injection site reactions, increased risk of infections, allergic reactions, and potential impacts on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I have 3 or more tender and swollen joints.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with inflammatory bowel disease.

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I've had unexplained diarrhea for over 3 weeks in the last 6 months.

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I have been diagnosed with arthritis mutilans.

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I have been treated with sonelokimab before.

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I have taken biologic treatments for Psoriatic Arthritis or Psoriasis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)

Secondary study objectives

Health Assessment Questionnaire- Disability Index (HAQ-DI)

Psoriasis Area and Severity Index (PASI90)

Response rate of participants achieving Minimal Disease Activity (MDA)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sonelokimab

2022

Completed Phase 2

~210

0 / 9Eligibility criteria met