Camoteskimab for Eczema

Recruiting at 41 trial locations

Overseen By Scott Fretzin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Apollo Therapeutics Ltd

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Other skin diseases, Severe comorbidities, Active infections, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of camoteskimab in adults with moderate to severe AD.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are using certain systemic therapies for eczema, you may need to stop them before joining the trial.

Eligibility Criteria

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.

Inclusion Criteria

My skin condition didn't improve with creams or lotions, or I can't use them for health reasons.

Participant provides signed informed consent

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

Exclusion Criteria

I have used more than two treatments for Alzheimer's disease.

Participant has severe or uncontrolled seasonal or allergic rhinitis, asthma or any other non-AD disease as judged by the Investigator

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Blinded Period)

Participants are randomized to receive either camoteskimab dose 1, camoteskimab dose 2, or placebo

16 weeks

Visits at Weeks 2, 4, 8, 12, and 16

Extension Period (Open-label)

All participants receive camoteskimab

16 weeks

Visits at Weeks 20, 24, 28, and 32

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Camoteskimab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Dose 2 Experimental Treatment 2 Interventions

Camoteskimab

Group II: Dose 1 Experimental Treatment 1 Intervention

Camoteskimab

Group III: Placebo Placebo Group 1 Intervention

Dummy version of the study drug

Who Is Running the Clinical Trial?

Apollo Therapeutics Ltd

Lead Sponsor

Trials

5

Recruited

330+