NCT03074942

Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab

Completed Phase 2 Last updated 16 May 2018

What this trial tests

Phase 2 trial testing Reslizumab in Severe Asthma in 30 participants. Completed in 30 April 2018.

Timeline

20 April 2017

Primary endpoint
26 March 2018

30 April 2018

Quick facts

Lead sponsor	Sociedad Española de Neumología y Cirugía Torácica
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	20 April 2017
Primary completion	26 March 2018
Estimated completion	30 April 2018
Sites	10 locations across Spain

Drugs / interventions tested

• Reslizumab (RESLIZUMAB) — full drug profile →

Conditions studied

• Severe Asthma — all drugs for Severe Asthma →

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Who can join

Adults 18 to 70, any sex, with Severe Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of life in severe allergic asthmatics. However, approximately 25% of the treated patients fail to respond to this monoclonal antibody. The rest of them show different degrees of response, although the rate of asthmatics who achieve control of the disease is unknown because clinical trials of omalizumab have been carried out to assess the impact of the drug on exacerbations, symptoms or even pulmonary function, but its effect on control was not evaluated. Therefore, there is a need to find new therapeutic options for those severe asthmatics who remain uncontrolled despite having received all the recommended therapies (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary function and symptoms in patients with severe asthma and high peripheral eosinophil counts. It would be important to demonstrate that Reslizumab is able to improve the clinical condition of severe asthma patients with no therapeutic options.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Packaging and Delivery of Asthma Therapeutics.
   Mathis BJ, Kusumoto M, Zaboronok A, Hiramatsu Y. · · 2021 · cited 9× · PMID 35056988 · DOI 10.3390/pharmaceutics14010092