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Monoclonal Antibodies

Sonelokimab for Psoriatic Arthritis (IZAR-2 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

6. Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with the TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.

1. Participants must be ≥18 years of age .

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16 compared to placebo

Awards & highlights

Pivotal Trial

Summary

This trial aims to determine if the drug sonelokimab is effective and safe in treating adults with active psoriatic arthritis who did not respond well to previous anti-TNF therapy.

Who is the study for?

This trial is for adults over 18 with active psoriatic arthritis and plaque psoriasis who haven't responded well to or can't tolerate TNFα inhibitors. They must have at least 3 tender and swollen joints, not have rheumatoid arthritis markers, and meet specific diagnostic criteria.

What is being tested?

The study tests the effectiveness of Sonelokimab against a placebo in those unresponsive to anti-TNFα treatments. It aims to confirm if Sonelokimab is safe and works better for managing symptoms of psoriatic arthritis.

What are the potential side effects?

While the side effects are not detailed here, similar medications often cause injection site reactions, increased risk of infections, headaches, fatigue, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have tried 1 or 2 TNFα inhibitors for my PsA or PsO without success or stopped due to side effects.

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I am 18 years old or older.

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I have 3 or more tender and swollen joints.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16 compared to placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16 compared to placebo

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

Treatment Details

Study Objectives

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

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

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: sonelokimab dose 2 with an induction regimenExperimental Treatment1 Intervention

Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8.

Group II: sonelokimab dose 1 with an induction regimenExperimental Treatment1 Intervention

Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.

Group III: risankizumabActive Control1 Intervention

Subjects randomized to this arm will receive risankizumab SC

Group IV: PlaceboPlacebo Group1 Intervention

Subjects randomized to this arm will receive placebo SC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sonelokimab

2022

Completed Phase 2

~210