Effects of Interleukin (IL)- 4R-alpha Inhibition on Respiratory Microbiome and Immunologic Correlates in Severe Asthma

NCT ID: NCT05036733

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2023-06-29

Brief Summary

The overall goal of this study is to understand biological responses related to dupilumab treatment among severe asthma patients.

Not all asthma is the same, and characteristics of asthma vary from person to person. The study will investigate whether the study drug can help to improve the health of participants lungs, boost immune response, as well as improve quality of life.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dupilumab

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits.

Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints.

Interventions

Dupilumab

Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits.

Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints.

Intervention Type: DRUG

Other Intervention Names

Dupixent

Eligibility Criteria

Inclusion Criteria

• Physician-diagnosed/managed severe asthma patients that are clinically eligible for dupilumab
• Current treatment with a medium-to-high-dose inhaled glucocorticoid (fluticasone propionate at a total daily dose of greater or equal (≥) 440 μg or equipotent equivalent) plus up to at least one additional controller (e.g., a long-acting β2-agonist or leukotriene receptor antagonist)
• Eosinophilic asthma phenotype (blood eosinophil level >300) or asthma requiring daily oral corticosteroids
• Asthma that is uncontrolled, as defined by a score on the Asthma Control Test of 19 or lower, or a worsening of asthma in the past year that led to an asthma hospitalization, Emergency Department visit, or 3 days of oral corticosteroids
• Severity of asthma that, in the opinion of the subject's asthma care specialist, requires dupilumab for control
• For women of childbearing age: agree to use birth control or remain abstinent during the duration of the study.

Exclusion Criteria

• Patients with diagnosis of other chronic lung diseases (e.g. Chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, etc.)
• Current smoker or reported smoking within 1 month of the screening visit (tobacco or any inhaled recreational product)
• Greater than 10 total pack-year of cigarette smoking history
• Treatment with oral corticosteroids for an asthma exacerbation 1 month prior to screening or during the screening period
• Use of any biologic therapy for asthma within the past 3 months
• Respiratory or Gastrointestinal illness within 1 month prior to screening or during the screening period
• Treatment with antibiotics for acute infections within six weeks prior to screening or during the screening period.
• Pregnancy at enrollment or during the study
• Known hypersensitivity to dupilumab or its excipients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Yvonne J Huang

Associate Professor of Internal Medicine and Microbiology/Immunology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yvonne Huang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00196809

Identifier Type: -

Identifier Source: org_study_id