Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Recruiting in Palo Alto (17 mi)

+202 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Galderma R&D

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

Eligibility Criteria

Inclusion Criteria

Male or female subjects aged ≥ 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years has been opened after the IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study

Chronic AD that has been documented for at least 2 years

EASI score ≥ 16

Participant Groups

Group I: Nemolizumab Experimental Treatment 1 Intervention

Nemolizumab Active

Group II: Placebo Placebo Group 1 Intervention

Placebo

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

🇺🇸 Approved in United States as Nemluvio for:

• Prurigo nodularis
• Atopic dermatitis

🇪🇺 Approved in European Union as Nemluvio for:

• Atopic dermatitis
• Prurigo nodularis

🇯🇵 Approved in Japan as Nemluvio for:

• Atopic dermatitis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Galderma Investigational Site 8648 Wilmington, NC

Galderma Investigational Site 8857 Oklahoma City, OK

Galderma Investigational Site 8664 Frisco, TX

Galderma Investigational Site 8726 Wilmington, NC

More Trial Locations

Who Is Running the Clinical Trial?

Galderma R&D Lead Sponsor

References