An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Genolar® + Symbicort®; Xolair® + Symbicort®
Intervention type(s): Biological; Biological
Intervention description(s): 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.; 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.
Other intervention name(s): omalizumab & (budesonide+formoterol); GNR-044 & (budesonide+formoterol); omalizumab & (budesonide+formoterol)
Intervention MeSH terms: Omalizumab; Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: omalizumab; humanized monoclonal antibodies; safety; bronchial asthma; equivalence; biosimilar; anti-allergic agents; anti-asthmatic agents; respiratory system agents; hypersensitivity; immune system diseases; urticaria; immunogenicity