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

Conditions

• Moderate-to-Severe Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo
• Nemolizumab — DRUG
  Nemolizumab

Study Details

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.

Key Dates

Start date

Jun 27, 2019

Status verified

Aug 2024

Primary completion

Dec 29, 2021

Completion

Aug 11, 2022

Study Design

Enrollment

941 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo
• Experimental: Nemolizumab
  Nemolizumab Active

Primary Outcome Measure

Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population [ Time Frame: Week 16 ]

Locations (57)

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