Study Testing Response Effect of KY1005 Against Moderate to Severe Atopic Dermatitis (STREAM-AD)
Research type
Research Study
Full title
A Phase IIb, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis (Study Testing Response Effect of KY1005 Against Moderate to Severe Atopic Dermatitis. The STREAM-AD Study)
IRAS ID
1004313
Contact name
James Barras
Contact email
Sponsor organisation
Kymab Limited
Eudract number
2021-000725-28
Research summary
Research of Summary
This is a Phase 2b study to test the response effect of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in adult patients with moderate to severe Atopic Dermatitis (AD). Patients that, in the last 6 months, may have had an inadequate response or are inadvisable to topical treatments, may be eligible to take part. During the study, patients will be administered with KY1005 across a range of four different doses/exposures or matching Placebo, for a maximum duration of up to 52 weeks. Patients will be randomised in a 1:1:1:1:1 to receive a subcutaneous dose of KY1005 or matching Placebo. A total of 350 patients will be randomised (approximately 70 patients per treatment arm), across different countries, including the United Kingdom.
AD, also known as atopic eczema, is the most common chronic inflammatory skin disorder, and it has a significant impact on the health and quality of life of individuals with the disease. Treatment for AD generally depends on the extent and severity/activity of the disease. Although several systemic treatments are available, many patients do not derive optimal benefit due to inadequate treatment responses or adverse reactions. KY1005 has, therefore, been developed to address the significant unmet medical need for treatment options in this patient population.
KY1005 has been administered to healthy volunteers (Studies KY1005-CT01 and KY1005-CT04) and to patients with moderate-to-severe AD ((Study KY1005-CT02)). One hypersensitivity reaction of the mouth and throat on first exposure to KY1005 was reported in KY1005-CT01 at a dose that exceeded the highest dose level planned for this Phase 2b study. No safety or tolerability concerns were noted when KY1005 was administered in KY1005-CT04. In the KY1005-CT02 study in participants with AD, KY1005 provided meaningful improvements in the signs and symptoms of AD and no safety or tolerability issues were noted.
In the UK, participating sites will be NHS sites with Dermatology speciality.Summary of Results
pending - The LSR will be posted on Sanofi website (https://www.trialsummaries.com) after EudraCT results is viewable to the public, expected late march of 2025.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0268
Date of REC Opinion
31 Jan 2022
REC opinion
Further Information Favourable Opinion