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Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma

A Phase II, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MEDI3506 in Adult Participants With Uncontrolled Moderate-to-severe Asthma

NCT04570657•AstraZeneca

View on ClinicalTrials.gov

Summary

Study D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study. Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 to \< 65 years of age
•Physician-diagnosed asthma of early onset, defined as development of asthma before the age of 25 years.
•History of ≥ 1 asthma exacerbation in previous 24 months
•Treated with medium to high dose ICS defined as total daily dose of \> 250 g fluticasone dry powder or equivalent, for at least 12 months and on a stable dose for ≥ 3 months.
•Stable LABA therapy for ≥ 3 months.
•An ACQ-6 score ≥ 1.5.
•Morning pre-BD FEV1 ≥ 40% predicted normal and \> 1 L.
•Morning pre-BD FEV1 \< 85% predicted normal.
•Participants with documented evidence of asthma as demonstrated by either:
•BD reversibility, within 12 months, or at screening, or
+5 more criteria

Exclusion Criteria

•Participants with a positive diagnostic nucleic acid test for SARS-CoV-2.
•Participants with a significant COVID-19 illness within 6 months of enrolment:
•Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or HIV.
•Evidence of active or latent TB:
•An LVEF \< 45% measured by echocardiogram during screening.
•A family history of heart failure.
•Current smokers or recent ex-smokers i.e., have quit e cigarettes or other inhaled tobacco products ≤ 6 months prior to SV1.
•Ex-smokers with a total smoking history of \> 10 pack years.
•As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (prior to randomisation) that in the investigator's opinion makes it undesirable for the participant to participate in the study.
•Any clinically important pulmonary disease other than asthma.
+10 more criteria

Locations (65)

Research Site

Bakersfield, California, United States

Research Site

Los Angeles, California, United States

Research Site

Newport Beach, California, United States

Research Site

Coral Gables, Florida, United States

Research Site

Ames, Iowa, United States

Research Site

Missoula, Montana, United States

Research Site

Toledo, Ohio, United States

Research Site

Edmond, Oklahoma, United States

Research Site

Boerne, Texas, United States

Research Site

Buenos Aires, Argentina

Key Dates

Start Date

September 17, 2020

Primary Completion Date

December 12, 2022

Completion Date

February 6, 2023

Last Updated

January 30, 2024

Enrollment

250

ACTUAL participants

Conditions

Asthma

Interventions

MEDI3506

BIOLOGICAL

Placebo

DRUG

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma