Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma
NCT ID: NCT04570657
Last Updated: 2024-01-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2020-09-17
2023-02-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
NCT01704495
Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA
NCT06020014
A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
NCT00830427
A Study to Investigate the Efficacy, Safety, and Tolerability of Repeat Doses of Inhaled GSK2269557 in Adults With Persistent, Uncontrolled Asthma
NCT02567708
Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma
NCT01000506
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MEDI3506 Dose 1
Approximately 76 participants will be randomized to this arm to receive the higher dose of MEDI3506
MEDI3506
Participants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2
MEDI3506 Dose 2
Approximately 76 participants will be randomized to this arm to receive the lower dose of MEDI3506
MEDI3506
Participants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2
Placebo
Approximately 76 participants will be randomized to this arm. Participants in this group will receive the placebo.
Placebo
Participants will receive multiple doses of placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MEDI3506
Participants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2
Placebo
Participants will receive multiple doses of placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Positive methacholine challenge test within 12 months.
* Bodyweight ≥ 40 kg and BMI \< 40 kg/m2.
* For female participants, a negative pregnancy test.
* Abide by contraception requirements for males and females
* Provide informed consent
Exclusion Criteria
* 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.
* Any other clinically relevant abnormal findings on physical examination or laboratory testing, that in the opinion of the investigator or medical monitor might compromise the safety of the participant in the study or interfere with evaluation of the study intervention.
* A known history of severe reaction to any medication including biologic agents or human gamma globulin therapy.
* History of, or a reason to believe, a participant has a history of, drug or alcohol abuse within the past 2 years.
* Current diagnosis of cancer.
* History of cancer, except if treated with apparent success with curative therapy (response duration of \> 5 years).
* History of allogeneic bone marrow transplant.
* A helminth parasitic infection diagnosed within 6 months prior to SV4 (randomisation) that has not been treated, or has not responded to SOC therapy.
* An asthma exacerbation within 8 weeks.
* Receiving any prohibited concomitant medications or therapies as specified in the protocol:
Known history of allergy or reaction to any component of the study intervention formulation, including hereditary fructose intolerance.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Florida, , Argentina
Research Site
Godoy Cruz, , Argentina
Research Site
Lanús Este, , Argentina
Research Site
Mar del Plata, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Quilmes, , Argentina
Research Site
San Juan Bautista, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Berlin, , Germany
Research Site
Cottbus, , Germany
Research Site
Frankfurt, , Germany
Research Site
Frankfurt am Main, , Germany
Research Site
Koblenz, , Germany
Research Site
Landsberg, , Germany
Research Site
Leipzig, , Germany
Research Site
Lübeck, , Germany
Research Site
Magdeburg, , Germany
Research Site
Mainz, , Germany
Research Site
Peine, , Germany
Research Site
Schwerin, , Germany
Research Site
Balassagyarmat, , Hungary
Research Site
Budapest, , Hungary
Research Site
Gödöllő, , Hungary
Research Site
Százhalombatta, , Hungary
Research Site
Szeged, , Hungary
Research Site
Bialystok, , Poland
Research Site
Bychawa, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Tarnów, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Bellville, , South Africa
Research Site
Benoni, , South Africa
Research Site
Bloemfontein, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Durban, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Welkom, , South Africa
Research Site
Bradford, , United Kingdom
Research Site
Cambridge, , United Kingdom
Research Site
High Wycombe, , United Kingdom
Research Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
d9181c00001-study-synopsis\_Redacted\_pdfA.pdf
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
140910
Identifier Type: OTHER
Identifier Source: secondary_id
2020-000789-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9181C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.