NCT03100344

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.

Detailed description

The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Nemolizumab	Injection every 4 weeks during 24 weeks (last injection at week 20)
DRUG	Placebo	Injection every 4 weeks during 24 weeks (last injection at week 20)

Timeline

• Start date: 2017-06-14
• Primary completion: 2018-07-19
• Completion: 2018-09-21
• First posted: 2017-04-04
• Last updated: 2019-10-22
• Results posted: 2019-10-22

Locations

67 sites across 6 countries: United States, Australia, Canada, France, Germany, Poland

Regulatory

• FDA-regulated drug study