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Monoclonal Antibodies

Camoteskimab for Eczema

Phase 2

Recruiting

Research Sponsored by Apollo Therapeutics Ltd

Eligibility Criteria Checklist

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

Must have

Participants must be 18-75 years of age inclusive, at the time of signing the informed consent

Chronic AD for at least 1 year

Must not have

Active human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), evidence of active or latent TB

Previous exposure to anti-IL-18 therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 36 weeks

Summary

This trial is testing a new drug called camoteskimab in adults with moderate to severe atopic dermatitis. It is a phase 2a study that is being conducted at multiple centers. The

Who is the study for?

Adults with moderate to severe atopic dermatitis (a type of eczema) can join this study. Participants must meet certain health standards, which are not specified here.

What is being tested?

The trial is testing the effects of a drug called Camoteskimab against a placebo (a substance with no active drug). It's a blind test, so participants won't know which one they're getting. The goal is to see if Camoteskimab helps with their skin condition.

What are the potential side effects?

Specific side effects for Camoteskimab aren't listed, but common ones for new treatments in skin conditions may include irritation at the site of application, itching, redness, 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 am between 18 and 75 years old.

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I have had atopic dermatitis for at least 1 year.

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I am using two effective birth control methods if I can have children.

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My eczema is severe, affecting more than 10% of my body and causes significant itching.

Exclusion Criteria

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

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I do not have active HIV, HBV, HCV, or TB.

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I have been treated with anti-IL-18 therapy before.

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I do not have any active skin conditions that could affect my eczema study participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 36 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To compare the clinical efficacy of camoteskimab with placebo in participants with AD

Secondary study objectives

All AEs and SAEs will be collected from the signing of the ICF until the EOS visit and all SAEs will be collected from the signing of the ICF until 3 months after the last dose of IMP

Change from baseline & change from W16 in AD involvement by BSA at W20, 24, 28, 32

Change from baseline & change from W16 in DLQI score at W20, 24, 28, 32

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