* A PoC study of CMK389 vs placebo in patients with atopic dermatitis.
Research type
Research Study
Full title
A randomized, subject and investigator blinded, placebo-controlled multicenter study to assess the efficacy and safety of CMK389 in patients with moderate to severe atopic dermatitis
IRAS ID
301532
Contact name
Claus-Peter Danzer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-003406-31
Duration of Study in the UK
1 years, months, 6 days
Research summary
This is a Phase II study, the main aim of which is to assess preliminary efficacy, safety and tolerability of CMK389 in participants with moderate to severe atopic dermatitis (AD). It is placebo-controlled (placebo being a dummy drug with no active ingredients)and CMK389/placebo will be given to 48 patients in total either via an injection or an intravenous infusion (an injection into a vein in the arm). From these 48 patients, 32 will receive active drug (CMK389) while 16 will receive placebo. Neither the patients nor the study doctors will know which treatment has been given. The screening period lasts up to one month and the treatment period twelve weeks, followed by a three month follow up period. All participants will receive a total of four infusions or injections over the 12-week treatment period. Patient safety will be monitored using physical examinations, lab assessments, ECG readings and recording vital signs. Questionnaires will be used by both investigators and patients to record any changes in skin condition throughout the course of the study. Patients will be invited to take part in skin biopsies and digital photography of their skin but these assessments are optional.
REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0247
Date of REC Opinion
21 Oct 2021
REC opinion
Further Information Favourable Opinion