*TIDE
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to assess the efficacy, safety, and tolerability of subcutaneous amlitelimab in adult participants with moderate to-severe asthma
IRAS ID
1005531
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
Sanofi-aventis recherche & développement
Eudract number
2022-000065-41
Clinicaltrials.gov Identifier
Research summary
Asthma is a chronic inflammatory disease of the airways characterised by airway hyperresponsiveness, acute and chronic bronchoconstriction, airway edema and mucus plugging. The inflammation component of asthma is thought to involve many cell types including epithelial cells, T lymphocytes, eosinophils, mast cells, neutrophils, innate lymphoid cells type 2 and their biological products. Patients with asthma most often present with symptoms of wheezing, shortness of breath, cough, and chest tightness.
Despite current treatment options, uncontrolled asthma continues to carry a significant burden.
For severe uncontrolled asthma patients, there are several currently approved biologics, however' when using currently available biologics, substantial proportions of patients continue to experience exacerbations and may benefit from agents that target different molecular pathways. Therefore, despite these additional therapeutic options, there is still a clear unmet medical need among patients with severe asthma.
The study tests amlitelimab, which is a monoclonal antibody. Monoclonal antibodies are antibodies produced in the laboratory designed to recognise and bind to specific receptors on the surface of cells. They are derived from natural antibodies, which are complex proteins derived from cells made by the body's immune system to recognise and fight off foreign invaders, such as bacteria and viruses. Amlitelimab binds to a substance in the body known as OX40 ligand (OX40L) which is crucial for the function of certain cells in our immune system. Those cells play an important role in coordinating immune response.
The objective of this study is to assess the efficacy and safety of amlitelimab, a human anti OX40L mAb, in participants with moderate-to-severe asthma which is not well controlled on ICS in combination with other controller medication with or without OCS therapy.
For this study, amlitelimab or placebo will be administered via a subcutaneous injection.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0188
Date of REC Opinion
23 Jun 2022
REC opinion
Further Information Favourable Opinion