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

NCT04674137 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-09-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • EURRUS Biotech GmbH

    collaborator INDUSTRY

  • Chemlmmune Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2021-08-27
Completion
2021-08-27

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674137 on ClinicalTrials.gov