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Monoclonal Antibodies

Sonelokimab for Hidradenitis Suppurativa

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 must be at least 18 years of age at the time of signing the informed consent

Participants with inadequate response to systemic antibiotics for treatment of hidradenitis suppurativa

Must not have

Participants with any other active skin disease or condition that may interfere with the assessment of HS

Participants with any other known autoimmune disease or medical condition that would interfere with an accurate assessment of clinical symptoms of HS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16 and week 52

Awards & highlights

Pivotal Trial

Summary

This trial will test a new drug called sonelokimab to see if it is effective and safe for treating adults with moderate to severe hidradenitis suppurativa. Participants will be randomly

Who is the study for?

Adults with moderate to severe hidradenitis suppurativa (HS), a skin condition, who haven't responded well to antibiotics can join this trial. They must have had HS symptoms for at least 6 months and have lesions in two or more areas, one with fistulas.

What is being tested?

The study is testing Sonelokimab, given under the skin, against a placebo to see if it's better for treating HS. Participants are randomly chosen to get either the real drug or placebo in a 2:1 ratio until Week 16 of the study.

What are the potential side effects?

Possible side effects of Sonelokimab may include reactions at the injection site, increased risk of infections due to immune system changes, headaches, fatigue and possibly other immune-related conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My skin condition didn't improve with antibiotics.

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I have HS lesions in 2 or more areas, with at least one area having fistulas.

Exclusion Criteria

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

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I do not have any skin conditions that could affect HS assessment.

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I do not have any autoimmune diseases that could affect my HS symptom assessment.

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I have a gastrointestinal condition like IBD, ulcerative colitis, or Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 and week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hidradenitis Suppurativa Clinical Response 75

Secondary study objectives

Change in International Hidradenitis Suppurativa Severity Score System

Dermatology Life Quality Index (DLQI)

Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

+3 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: sonelokimabExperimental Treatment1 Intervention

Subjects randomized to this arm will receive sonelokimab 120 mg Q2W from Weeks 0 to 6 then 120 mg Q4W starting at Week 8 up to Week 48.

Group II: PlaceboPlacebo Group1 Intervention

Subjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sonelokimab

2022

Completed Phase 2

~210

0 / 6Eligibility criteria met