Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma
FRONTIER-3
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
3 other identifiers
interventional
250
7 countries
65
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Sep 2020
Typical duration for phase_2 asthma
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2020
CompletedStudy Start
First participant enrolled
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2023
CompletedResults Posted
Study results publicly available
January 30, 2024
CompletedJanuary 30, 2024
January 1, 2024
2.2 years
August 7, 2020
December 12, 2023
January 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 16 in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in the First Second (FEV1) as Measured in the Study Clinic
In-clinic spirometry measurements were taken prior to the administration of bronchodilators. Baseline was the last measurement prior to first injection of investigational product (IP). The least squares (LS) means, LS mean differences and 80% confidence intervals (CIs), and one-sided p-value results were based on a mixed model repeated measures (MMRM). The model included fixed effects for baseline, background medication, geographic region, baseline inhaled corticosteroids (ICS) total daily dose, visit, treatment, and the baseline by visit and treatment by visit interactions. Visits within participant were considered as repeated measurements.
Baseline and week 16
Secondary Outcomes (11)
Change From Baseline to Weeks 8 and 16 in Post-bronchodilator (Post-BD) FEV1 as Measured in the Study Clinic
Baseline and weeks 8 and 16
Serum Concentrations of Tozorakimab
Pharmacokinetic (PK) samples were taken pre-dose (day 1) and at weeks 1, 4, 8, 12, 16, 20, and 24
Number of Participants With Anti-drug Antibodies (ADAs)
Blood samples were taken pre-dose (day 1) and at weeks 1, 4, 8, 12, 16, and 24
Change From Baseline to Week 16 in the Asthma Control Questionnaire-6 (ACQ-6) Score
Baseline and week 16
Number of Participants With a Decrease in ACQ-6 Score ≥ 0.5 From Baseline to Week 16
Baseline and week 16
- +6 more secondary outcomes
Other Outcomes (2)
Change From Baseline to Week 16 in Pre-BD FEV1 as Measured in the Study Clinic: Analysis Per Number of Exacerbations in Last 12 Months
Baseline and week 16
Eosinophil Count
Baseline and Week 16
Study Arms (3)
MEDI3506 Dose 1
EXPERIMENTALApproximately 76 participants will be randomized to this arm to receive the higher dose of MEDI3506
MEDI3506 Dose 2
EXPERIMENTALApproximately 76 participants will be randomized to this arm to receive the lower dose of MEDI3506
Placebo
PLACEBO COMPARATORApproximately 76 participants will be randomized to this arm. Participants in this group will receive the placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
- 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).
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (65)
Research Site
Bakersfield, California, 93301, United States
Research Site
Los Angeles, California, 90025, United States
Research Site
Newport Beach, California, 92663, United States
Research Site
Coral Gables, Florida, 33134, United States
Research Site
Ames, Iowa, 50010-3014, United States
Research Site
Missoula, Montana, 59808, United States
Research Site
Toledo, Ohio, 43617, United States
Research Site
Edmond, Oklahoma, 73034, United States
Research Site
Boerne, Texas, 78006, United States
Research Site
Buenos Aires, C1121 ABE, Argentina
Research Site
Buenos Aires, C1414AIF, Argentina
Research Site
CABA, C1425BEN, Argentina
Research Site
Córdoba, X5003DCE, Argentina
Research Site
Florida, B1602DQD, Argentina
Research Site
Godoy Cruz, 5501, Argentina
Research Site
Lanús Este, B1824KAJ, Argentina
Research Site
Mar del Plata, 7600, Argentina
Research Site
Mendoza, 5500, Argentina
Research Site
Mendoza, M5500GHB, Argentina
Research Site
Quilmes, B1878FNR, Argentina
Research Site
San Juan Bautista, 1888, Argentina
Research Site
San Miguel de Tucumán, 4000, Argentina
Research Site
Berlin, 10717, Germany
Research Site
Cottbus, 03050, Germany
Research Site
Frankfurt, 60596, Germany
Research Site
Frankfurt am Main, 60389, Germany
Research Site
Koblenz, 56068, Germany
Research Site
Landsberg, 86899, Germany
Research Site
Leipzig, 04357, Germany
Research Site
Lübeck, 23552, Germany
Research Site
Magdeburg, 39120, Germany
Research Site
Mainz, 55128, Germany
Research Site
Peine, 31224, Germany
Research Site
Schwerin, 19055, Germany
Research Site
Balassagyarmat, 2660, Hungary
Research Site
Budapest, 1033, Hungary
Research Site
Gödöllő, 2100, Hungary
Research Site
Százhalombatta, 2440, Hungary
Research Site
Szeged, 6722, Hungary
Research Site
Bialystok, 15-044, Poland
Research Site
Bychawa, 23100, Poland
Research Site
Bydgoszcz, 85-231, Poland
Research Site
Katowice, 40-648, Poland
Research Site
Krakow, 30-033, Poland
Research Site
Lodz, 90-302, Poland
Research Site
Lublin, 20-362, Poland
Research Site
Poznan, 60-214, Poland
Research Site
Tarnów, 33-100, Poland
Research Site
Wroclaw, 53-301, Poland
Research Site
Wroclaw, 54-239, Poland
Research Site
Bellville, 7530, South Africa
Research Site
Benoni, 1500, South Africa
Research Site
Bloemfontein, 9301, South Africa
Research Site
Cape Town, 7500, South Africa
Research Site
Cape Town, 7572, South Africa
Research Site
Cape Town, 7700, South Africa
Research Site
Durban, 4001, South Africa
Research Site
Durban, 4091, South Africa
Research Site
Johannesburg, 2113, South Africa
Research Site
Pretoria, 0002, South Africa
Research Site
Welkom, 9460, South Africa
Research Site
Bradford, BD9 6RJ, United Kingdom
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
High Wycombe, HP11 2QW, United Kingdom
Research Site
London, W1T 6AH, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
15 participants enrolled at 1 study centre were excluded from the final analysis due to inability to confirm the validity of the data reported by the site. The exclusion of data from this site did not change the interpretation of the primary endpoint, or results in a significant change to the interpretation of any other endpoint.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca AB
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2020
First Posted
September 30, 2020
Study Start
September 17, 2020
Primary Completion
December 12, 2022
Study Completion
February 6, 2023
Last Updated
January 30, 2024
Results First Posted
January 30, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.