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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
Awards & highlights
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 belowSelect...
I am between 18 and 75 years old.
Select...
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:Select...
I do not have active HIV, HBV, HCV, or TB.
Select...
I have been treated with anti-IL-18 therapy before.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To compare the clinical efficacy of camoteskimab with placebo in participants with AD
Secondary outcome measures
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
+31 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 2Experimental Treatment2 Interventions
Camoteskimab
Group II: Dose 1Experimental Treatment1 Intervention
Camoteskimab
Group III: PlaceboPlacebo Group1 Intervention
Dummy version of the study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Apollo Therapeutics LtdLead Sponsor
3 Previous Clinical Trials
217 Total Patients Enrolled
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