*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
Research Summary:
• What is amlitelimab? This is a new medicine being developed to treat diseases caused by the immune system not working correctly,
such as in asthma.
• Reason for this study: This study was done to find out if amlitelimab, compared to a placebo (dummy medicine), was safe and
effective in decreasing the number of severe asthma attacks in people with moderate or severe asthma. They also wanted to find
the best dose. People could take part in the study if they continued to have uncontrolled asthma symptoms even after taking standard
asthma medications.
• What was tested? Three different doses (lower, medium, higher) of amlitelimab were compared to a placebo.
• Who took part in this study? A total of 437 adults with uncontrolled moderate or severe asthma took part across 14 countries.
• Results of the study: There was a lower number of severe asthma attacks in people who took the medium dose of amlitelimab compared
to people who took a placebo. However, more research is needed to confirm these results and decide on the best dose to use.
• Safety: Amlitelimab was generally well tolerated by people who took part in the study. There were no unexpected safety problems found in
this study.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