Efficacy & 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

First listed

Jun 18, 2019

Start date

Jun 30, 2019

Status verified

Aug 2024

Primary completion

Feb 23, 2022

Completion

Sep 26, 2022

Study Design

Enrollment

787 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo administered via subcutaneous injection
• Experimental: Nemolizumab
  Nemolizumab administered via subcutaneous injection

Primary Outcome Measure

Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population [ Time Frame: Week 16 ]

Locations (47)

Find similar trials in Birmingham, AL

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• A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis
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