RIVER - AD
Research type
Research Study
Full title
A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis who participated in KY1005-CT05 (DRI17366).
IRAS ID
1005865
Contact name
Michael Cork
Contact email
Sponsor organisation
Sanofi-aventis recherche & développement
Eudract number
2021-002344-73
Clinicaltrials.gov Identifier
Research summary
Atopic dermatitis (AD), also known as atopic eczema, is the most common skin disorder in the developed world. Characterised by itchy skin and cutaneous (skin) lesions. The condition has a significant impact on the health and quality of life of individuals with the disease affecting social functioning and psychological well-being. Treatment of AD can depend on the extent and severity/activity of the disease, and when topical therapies (creams, ointments) are insufficient to treat signs and symptoms, systemic therapy (oral or injected medications) or phototherapy (UV exposure) are added. Amlitelimab (also known as KY1005, KY1005 2D10 or SAR445229) is the treatment/study drug under investigation that is able to block the one signal pathway that can cause the inflammatory process that leads to AD. Although several systemic treatments are available, many patients do not derive optimal benefit due to either incomplete treatment responses or due to adverse reactions. Amlitelimab, (a human anti OX40L mAb), has therefore been developed to address the significant unmet medical need for treatment options. The primary purpose of this study is to characterize the safety of amlitelimab in adult participants aged 18 years and above with moderate to severe AD who have previously taken part in and rolled over from the KY1005-CT05 (DRI17366) study. The primary aim is being evaluated by the percentage of participants who experienced treatment-emergent adverse events from baseline during the study. All sites will have previously conducted the pre-cursor study. The study is single arm meaning only one treatment is given via subcutaneous (skin) injection. Participants will be enrolled for a possible study duration of 120 weeks. Study closure is expected Dec 2025.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0184
Date of REC Opinion
1 Nov 2022
REC opinion
Further Information Favourable Opinion