Study of KY1005 in Patients with Moderate to Severe Atopic Dermatitis
Research type
Research Study
Full title
A Phase IIa, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti-OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
IRAS ID
254218
Contact name
Michael J. Cork
Contact email
Sponsor organisation
Kymab Limited
Eudract number
2018-002299-41
Duration of Study in the UK
1 years, 7 months, 7 days
Research summary
Atopic dermatitis (AD), also known as atopic eczema, is the most common inflammatory skin disorder in the world affecting an estimated 230 million people worldwide. At the patient level AD has a diverse and significant negative impact on quality of life and patient physical and psychological wellbeing and places a tremendous financial burden on both society and patients.
AD is a chronic skin disease that can relapse and flare. It is characterised by intense Itching (and subsequent scratching) and recurrent skin inflammation, caused by an abnormal response of the skin to allergens.
Current treatment options are limited mainly by side effects and this leaves patients hugely underserved in terms of longer term treatment options. Newer medicines called ‘biologics’ have been shown to significantly improve both the changes in the skin and how patients feel about their disease. However, as AD is a chronic long-lasting disease the long-term benefits will only be evident with broader use outside of clinical trials. Due to the chronic nature of the disease, and thus need for long-term treatment it’s expected that many patients will have their treatment limited either by a loss of response or the emergence of side effects over time. Thus, there remains a significant unmet need in AD with a need to develop medicines that not only address the immediate symptoms but also how the disease changes over the longer terms to give longer term relief.
KY1005 is a new ‘biologic’ medicine that blocks the communication between certain cells known to misbehave in AD causing the inflammation of the skin. The current study looks to test whether KY1005 is safe and brings benefit in patients with moderate to severe AD who have failed to respond to other therapies or have experienced unacceptable side effects to those previous therapies.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0407
Date of REC Opinion
22 Jan 2019
REC opinion
Further Information Favourable Opinion