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

NCT04674137 | Completed Phase 2

• 1 other identifier: PULM-XC8-04
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 18

Brief 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

Bronchial Asthma; Eosinophilic Asthma

Outcome Measures

Primary Outcomes (1)

• Rate of achieving the minimal clinically significant absolute change in FEV1 (+200 mL)

  To assess the rate of achieving minimal clinically significant absolute change in FEV1 measured in mL compared to baseline through spirometry testing.

  Week 0 - Week 12

Secondary Outcomes (9)

• Changes in FEV1 (in mL)

  Week 0 - Week 12

• Changes in FEV1 (in % of predicted)

  Week 0 - Week 12

• Change in Peak Expiratory Flow (PEF) Rate

  Week 0 - Week 12

• Change in forced vital capacity of lungs (FVC) in % of predicted

  Week 0 - Week 12

• Change in FEV1/FVC (in % of predicted)

  Week 0 - Week 12

Study Arms (2)

XC8 100 mg

EXPERIMENTAL

XC8 100 mg orally

Drug: XC8 100 mg

Placebo

PLACEBO COMPARATOR

Placebo orally

Drug: Placebo

Interventions

XC8 100 mg DRUG

1 tablet of XC8 100 mg once daily in the morning during 12 weeks of treatment period.

Also known as: Histamine glutarimide

XC8 100 mg

Placebo DRUG

1 tablet of placebo once daily in the morning during 12 weeks of treatment period.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form;
• Male and female non-smokers of 18 to 65 years of age (inclusive);
• The diagnosis of asthma not earlier than 12 months prior to screening;
• Steps 2 and 3 according to Global Initiative for Asthma (GINA, 2019) recommendations;
• Patients receiving stable ICS doses with or without long-acting β2-agonists;
• Еosinophil blood level measured twice at a 1 week interval, of ≥ 300 cells/µl ;
• Signs of partially controlled BA within 4 weeks prior to screening according to GINA 2019 recommendations;
• FEV1 value prior to the use of bronchodilators in the range of 55 to 85% of the proper value (inclusive);
• Consent of patients to use adequate contraception methods throughout the study;
• Ability to comply with all the study protocol requirements.

You may not qualify if:

• Pregnant or lactating women, or women planning to get pregnant during the clinical study; women of child-bearing potential (including those without history of surgical sterilization and women with \<2 years post-menopause) not using adequate contraception methods;
• Smoking for 1 year prior to screening or previous smoking history of more than 10 packs/year;
• Severe exacerbations or uncontrolled BA within 3 months prior to screening;
• Chronic obstructive pulmonary disease (COPD) or other serious lung diseases other than asthma;
• Inflammatory diseases of the oral cavity at screening;
• An acute infectious disease within 30 days prior to screening;
• Participation in any clinical study or any study drug administration within 30 days prior to screening;
• Taking or indications for taking of prohibited drugs (including anti-leukotriene preparations, modified-release theophylline, etc.);
• Indications for long-term use of systemic steroids or nonsteroidal anti-inflammatory drugs or drugs affecting on the immune system;
• The need for periodical intake of antihistamines during the study (stable doses of antihistamines for at least 1 month prior to screening and throughout the study is allowed);
• Immunosuppressant therapy within 3 months prior to screening;
• Anaphylaxis, generalized urticaria, or angioedema within 1 year prior to screening;
• Known allergies, hypersensitivity or contraindications for XC8 or its ingredients;
• A history of systemic autoimmune diseases or vascular collagenosis;
• Malignancies within the last 5 years (except for the cured basal cell carcinoma);

Sponsors & Collaborators

• Chemlmmune Therapeutics LLC: lead
• EURRUS Biotech GmbH: collaborator

Study Sites (18)

Federal State Autonomous Educational Institution of Higher Education "Immanuel Kant Baltic Federal University"of Ministry of Health of the Russian Federation

Kaliningrad, 236016, Russia

Location

Federal State Autonomous Educational Institution of Higher Education "Kazan (Volga region) Federal University"

Kazan', 420008, Russia

Location

Federal State Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation

Kazan', 420012, Russia

Location

State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital n.a. D.D.Pletnev" of the Moscow Department of Healthcare"

Moscow, 105077, Russia

Location

State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 52" of the Moscow Department of Healthcare

Moscow, 123182, Russia

Location

Federal State Educational Institution of Higher Education "Moscow State University of Medicine and Dentistry n.a.A.I.Yevdokimov" of Ministry of Health of the Russian Federation

Moscow, 127473, Russia

Location

State Budgetary Health Institution Republic of Karelia "Republican Hospital named V.A.Baranov"

Petrozavodsk, 185019, Russia

Location

JSC "Polyclinic complex"

Saint Petersburg, 190013, Russia

Location

State Budgetary Institution of Healthcare "Leningrad region Clinical Hospital"

Saint Petersburg, 194291, Russia

Location

LLC "Medical Center" Reavita Med St. Petersburg"

Saint Petersburg, 194354, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare "City polyclinic №117"

Saint Petersburg, 194358, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare St. Martyr Elizabeth City Hospital"

Saint Petersburg, 195257, Russia

Location

LLS Research Center for Eco-Security

Saint Petersburg, 196143, Russia

Location

Federal State Autonomous Educational Institution of Higher Education "Pavlov First Saint Petersburg State Medical University"of the Ministry of Health of the Russian Federation

Saint Petersburg, 197022, Russia

Location

LLS "Mayle"

Saint Petersburg, 199406, Russia

Location

State Healthcare Institution "Regional Clinical Hospital"

Saratov, 410053, Russia

Location

LLS diagnostic clinic "Konstanta"

Yaroslavl, 150003, Russia

Location

State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov" of Ministry of Health of the Russian Federation

Yaroslavl, 150003, Russia

Location

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Interventions

histamine glutarimide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: For blinding purposes the Placebo was made with the corresponding labelling of the study drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At Visit 3, Week 0 all patients were randomized into 2 groups in 1:1 ratio (35 patients to group of XC8 100 mg and 35 patients to Placebo group).

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: December 16, 2020
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (18)