Nemolizumab for Atopic Dermatitis

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Galderma R&D

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing nemolizumab, a medication, to see how it affects the body's ability to process other drugs. Nemolizumab has been previously studied for its effectiveness in treating atopic dermatitis. The study focuses on adults with moderate to severe atopic dermatitis, a skin condition. Researchers want to understand if nemolizumab changes how these patients' bodies handle a mix of common medications.

Eligibility Criteria

Adults with moderate-to-severe atopic dermatitis covering at least 10% of their body, an EASI score >=16, and a history of poor response to topical treatments can join. They must not weigh less than 45 kg, have poorly controlled asthma or recent severe exacerbations, be current smokers, or have certain infections including COVID-19 recently.

Inclusion Criteria

You have eczema that covers at least 10% of your body.

Your eczema is very severe, with a score of 16 or higher on two separate visits.

You have a moderate to severe skin condition based on the doctor's assessment.

+3 more

Exclusion Criteria

You weigh less than 45 kilograms (about 99 pounds).

You have been hospitalized for a severe asthma attack in the past year.

Your asthma has not been well-controlled in the last 3 months.

+18 more

Participant Groups

The trial is testing the effects of Nemolizumab on how the body processes a mix of drugs that are markers for CYP450 enzyme activity. It aims to understand if Nemolizumab alters the breakdown of these drugs in adults with moderate-to-severe atopic dermatitis.

1Treatment groups

Experimental Treatment

Group I: CYP 450 Substrates plus NemolizumabExperimental Treatment2 Interventions

Participants will receive 1 single oral dose of selected, commercially available, cytochrome P450 substrates (CYP450-S) on Day 1 and after a 1-week washout period, participants will receive a 60 milligram (mg) loading dose of nemolizumab via 2 consecutive subcutaneous (SC) 30-mg injections at the Week 1 visit, followed by a single 30-mg injection once in every 4 weeks (Q4W) at Week 5 and Week 9. Participants will receive a second oral dosing of CYP450-S at Week 10.

Nemolizumab is already approved in United States, European Union, Japan for the following indications:

🇺🇸 Approved in United States as Nemluvio for: