A Long-Term Extension Study to assess Nemolizumab in Atopic Dermatitis
Research type
Research Study
Full title
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis
IRAS ID
283222
Contact name
Andrew Pink
Contact email
Sponsor organisation
Galderma S.A.
Eudract number
2019-001889-15
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117122, IND Number
Duration of Study in the UK
2 years, 2 months, 22 days
Research summary
This study is a long-term extension study of nemolizumab for adults and adolescents with Atopic Dermatitis (AD). AS is a chronic inflammatory skin disease estimated to affect between 10% and 20% of the population, and up to 25% of children.
The main purpose of the study is to assess the long-term safety and effect of nemolizumab in adults and adolescents who have previously taken part in the phase 3 study. Participants from the phase 3 study may be invited to take part even if they did not respond to the initial treatment phase of the phase 3 study.
The study will include approximately 1300 participants in multiple sites worldwide. Each participant will receive the study drug. Participants will apply a moisturiser once daily for the duration of the study.
Participants will initially receive 2 injections, administered under the skin (subcutaneously "SC"). One of these injections will be nemolizumab and the other will be either nemolizumab or placebo, depending on which study treatment and dosage was received in the phase 3 study. Participants will continue to receive nemolizumab every 4 weeks, by SC injection, for the duration of the study.
Other study procedures include physical examination, blood and urine samples, vital signs and ECG.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0276
Date of REC Opinion
17 Sep 2020
REC opinion
Further Information Favourable Opinion