NCT04674137

XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma

Multicenter, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Efficacy and Safety of XC8 in Patients With the Eosinophilic Phenotype of Bronchial Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Chemlmmune Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, double-blind, randomized, pilot study in parallel groups to assess the efficacy and safety of XC8 at a dose of 100 mg versus placebo over a 12-week treatment period in non-smoking patients with a confirmed bronchial asthma (BA) and the eosinophil blood level 2 times within 1 week interval of ≥ 300 cells/μl. Study design was developed by Chemlmmune Therapeutics LLC, Russia in cooperation with Eurrus Biotech GmbH, Austria.

Detailed description

The study consists of 3 periods: screening (2 weeks), treatment period (12 weeks) and follow-up (2 weeks). All eligible patients are randomized into one of two treatment groups in a ratio of 1:1. During the study patients will continue to receive stable doses of inhaled corticosteroids (ICS) with or without the long-acting β2-agonists; when required, patients will receive short-acting β2-agonists.The randomized patients will be stratified by the site, baseline forced expiratory volume (FEV1) in the range of 55 to 70% and 71% to 85%, and therapy of BA (inhaled corticosteroids (ICS) with or without long-acting β2 agonists). The Study drug is produced by Hennig Arzneimittel GmbH und Co., Germany.

Conditions

• Bronchial Asthma
• Eosinophilic Asthma

Interventions

Type	Name	Description
DRUG	XC8 100 mg	1 tablet of XC8 100 mg once daily in the morning during 12 weeks of treatment period.
DRUG	Placebo	1 tablet of placebo once daily in the morning during 12 weeks of treatment period.

Timeline

• Start date: 2020-12-16
• Primary completion: 2021-08-27
• Completion: 2021-08-27
• First posted: 2020-12-19
• Last updated: 2021-09-22

Locations

18 sites across 1 country: Russia