NCT04607629

An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma

A Comparative Study of Efficacy and Safety of Genolar® and Xolar® in Treating Patients With Moderate to Severe Persistent Atopic Bronchial Asthma Inadequately Controlled With Stage 4 GINA (2017) Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, comparative, parallel-group study of the efficacy and safety of Genolar® and Xolair® in the treatment of persistent atopic bronchial asthma of moderate and severe course, whose symptoms are insufficiently controlled by the 4-step treatment GINA (2017)

Detailed description

There is an increasing incidence of bronchial asthma (BA) and other allergic diseases around the world. Bronchial asthma suffers from 4 to 10% of the world population, in Russian Federation, the incidence of BA across the adult population ranges from 2.2 to 5-7%, in the child population is about 10%. Severe BA is associated not only with frequent hospitalizations and increased mortality but also with high treatment costs. As to it, there is a hot button issue of developing new drugs for treating patients not to be achieved effectively with standard therapy. Considering the leading pathogenesis role of IgE-mediated allergy, the use of drugs to block IgE makes it possible to control the disease at the earliest allergic reaction phase of the development. It was shown that the IgE elimination from the mast cells and basophils surface reduced the severity of acute allergic reactions, reduced the allergen-induced late phase of the immune response and infiltration with inflammatory cells. These anti-IgE antibodies effects have been shown in various studies. Genolar® (omalizumab) (JSC "GENERIUM", the Russian Federation) is a humanized recombinant monoclonal antibody selectively binding to immunoglobulin (IgE) and is a biosimilar of Xolar® ("Novartis Pharma AG", Switzerland). This III phase study is aimed to compare the effectiveness, safety and immunogenicity of Genolar® (JSC "GENERIUM", Russia) and Xolair® to register of the drug Genolar® (JSC "GENERIUM", the Russian Federation), a lyophilizate for subcutaneous administration, in the Russian Federation. The study included patients (n = 192) aged 18 to 75 years with moderate to severe persistent atopic bronchial asthma. The diagnosis was documented for ≥1 year. The symptoms of the disease were insufficiently controlled by therapy corresponding to the 4th stage of treatment (GINA, 2017) during ≥2 months before screening. With block randomization, the patients were divided into two groups in a 2: 1 ratio: in group 1 - 127 patients received treatment with Genolar® for 52 weeks ± 3 days, in group 2 - 64 patients received treatment with Xolair® for 26 weeks ± 3 days. The study consisted of a screening period, an induction period for basic treatment standardizing with the using inhaled budesonide + formoterol, a comparative period of treatment with the studied drugs (Genolar® vs. Xolair®) for 26 weeks ± 3 days, and an additional period of continuing treatment with Genolar® for 26 ± 1 week for its long-term immunogenicity study.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Genolar® + Symbicort®	The experimental drug dose and administration frequency were determined based on baseline IgE concentration (IU / ml) measured before treatment and current body weight (kg). Depending on the initial IgE concentration and body weight the recommended drug dose was from 75 to 600 mg once in 2 or 4 weeks. The experimental drug Genolar® and the reference drug Xolair® were administered subcutaneously for 26 weeks. Budesonide + formoterol inhalation (dosed powder for inhalation, each delivered dose contains 320 μg budesonide and formoterol fumarate dihydrate 9 μg)) 1 inhalation 2 times a day.
BIOLOGICAL	Xolair® + Symbicort®	The experimental drug dose and administration frequency were determined based on baseline IgE concentration (IU / ml) measured before treatment and current body weight (kg). Depending on the initial IgE concentration and body weight the recommended drug dose was from 75 to 600 mg once in 2 or 4 weeks. The experimental drug Genolar® and the reference drug Xolair® were administered subcutaneously for 26 weeks. Budesonide + formoterol inhalation (dosed powder for inhalation, each delivered dose contains 320 μg budesonide and formoterol fumarate dihydrate 9 μg)) 1 inhalation 2 times a day.

Timeline

• Start date: 2018-06-20
• Primary completion: 2019-04-29
• Completion: 2019-12-13
• First posted: 2020-10-29
• Last updated: 2020-10-29

Locations

24 sites across 1 country: Russia