A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
FRONTIER-4
2 other identifiers
interventional
137
15 countries
90
Brief Summary
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult participants with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2020
Typical duration for phase_2
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedStudy Start
First participant enrolled
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2023
CompletedResults Posted
Study results publicly available
February 27, 2025
CompletedFebruary 27, 2025
February 1, 2025
2.5 years
October 20, 2020
November 7, 2024
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic
The mean change from baseline in Pre-BD FEV1 at Week 12 (tozorakimab - placebo) estimated using a repeated measures mixed effects analysis of covariance measures was estimated. Data available from all visits up to and including Week 12, irrespective of whether the participant discontinued study drug or received reliever therapy was considered. FEV1 was measured by spirometry at clinic.
Baseline (Day -35 to Day -28) through Week 12
Secondary Outcomes (23)
Serum Tozorakimab Concentration
Post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36
Number of Participants With Positive Anti-drug Antibodies (ADA) to Tozorakimab
Pre-dose at Study Weeks 0 (baseline) and post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36
Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event
Baseline (Day -35 to Day -28) through Week 28
Change From Baseline to Week 12 in 4-weekly Mean Evaluating Respiratory Symptoms of COPD (E-RS:COPD) Total Score
Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Change From Baseline to Week 12 in Mean Breathlessness, Cough and Sputum Scale (BCSS) Score (Over the Previous 4 Weeks)
Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
- +18 more secondary outcomes
Other Outcomes (1)
Change From Baseline in Post-BD FEV1 To Weeks 12 and 28
Baseline (Week -5 to -4) to Weeks 12 and 28 post-dose
Study Arms (2)
Tozorakimab
EXPERIMENTALParticipants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).
Placebo
PLACEBO COMPARATORParticipants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.
Interventions
Participants will receive SC injection of tozorakimab as stated in arm description.
Eligibility Criteria
You may qualify if:
- Provision of informed consent.
- Participant must be 40 to 80 years of age inclusive, at the time of signing the informed consent form (ICF).
- Participants who are current or ex-smokers with a tobacco history of \>= 10 pack-years.
- Participants who have a documented history of COPD for at least 1 year.
- Participants who have a post-BD FEV1/FVC \< 0.70 and a post-BD FEV1 \>= 20% and \< 80% predicted normal value at screening. Centralized spirometry will be used for this criteria assessment.
- Participants who have a physician confirmed participant history of chronic bronchitis as defined as presence of cough and sputum on most days for \>= 3 months/year in at least the 2 year period immediately prior to study visit 1 (SV1) (Screening).
- Participants who have an average BCSS score of \>= 2 in cough and \>= 2 in sputum domains assessed over 14 days preceding SV3.
- Participants who have a documented stable regimen of dual therapy or triple therapy for \>= 3 months prior to enrolment; there should have been no change in treatment after the previous exacerbation prior to entering into the study. Where dual therapy consists of inhaled corticosteroids (ICS) + long-acting beta 2 agonist (LABA) or LABA + long-acting muscarinic receptor antagonist (LAMA), and triple therapy consists of ICS + LABA + LAMA.
- Participants who have a documented history of \>= 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days duration (or 1 injection of depot formulation), or hospitalization for reason of AECOPD in the previous 24 months.
- Body mass index within the range 18 to 40 kg/m\^2 (inclusive).
- Female participants of childbearing potential, must have negative pregnancy tests.
- Male and female participants must follow protocol contraceptive guidance.
You may not qualify if:
- Participants with a positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening. Participants with mild or asymptomatic disease could be rescreened.
- Participants with a significant coronavirus disease 2019 (COVID-19) illness within 6 months of enrolment.
- As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason which in the investigator's opinion makes it undesirable for the participant to participate in the study.
- Current or past diagnosis of asthma which persisted beyond age of 25 years.
- Clinically important pulmonary disease other than COPD, radiological findings, and/or laboratory findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms.
- Increased pre-BD FEV1 at randomization visit (SV3) compared to Screening SV1 of \>= 400 mL or \>= 25% of SV1 FEV1.
- Any other clinically relevant abnormal findings on physical examination, laboratory testing; or chest CT scan, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study.
- Chest CT scan findings requiring further investigation or repeat CT surveillance before SV14.
- A family history of heart failure.
- A LVEF \< 45% measured by echocardiogram.
- History of a clinically significant infection (viral, bacterial, or fungal) within 4 weeks.
- History of, or a reason to believe a participant has a history of, drug or alcohol abuse within the past 2 years prior to screening.
- 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 human immunodeficiency virus (HIV).
- Evidence of active or untreated latent tuberculosis (TB).
- Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (90)
Research Site
Sheffield, Alabama, 35660, United States
Research Site
Newport Beach, California, 92663, United States
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Newark, Delaware, 19713, United States
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Kissimmee, Florida, 34746, United States
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Ormond Beach, Florida, 32174, United States
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Winter Park, Florida, 32789, United States
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Lakeside Park, Kentucky, 41017, United States
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White Marsh, Maryland, 21162, United States
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Ann Arbor, Michigan, 48197, United States
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New Bern, North Carolina, 28562, United States
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Columbus, Ohio, 43215, United States
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Oklahoma City, Oklahoma, 73120, United States
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Pittsburgh, Pennsylvania, 15213, United States
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North Charleston, South Carolina, 29406, United States
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Spartanburg, South Carolina, 29303, United States
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Boerne, Texas, 78006, United States
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Nedlands, 6009, Australia
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South Brisbane, 4101, Australia
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Spearwood, 6163, Australia
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Tarragindi, 4121, Australia
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G2J 0C4, Canada
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Sherbrooke, Quebec, J1L 0H8, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Brno, 625 00, Czechia
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Olomouc, 77900, Czechia
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Písek, 397 01, Czechia
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Prague, 140 46, Czechia
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Rokycany, 337 22, Czechia
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Aalborg, 9000, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Næstved, 4700, Denmark
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Odense C, 5000, Denmark
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Bamberg, 96049, Germany
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Berlin, 10717, Germany
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Berlin, 13187, Germany
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Darmstadt, 64283, Germany
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Hanover, D-30173, Germany
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Leipzig, 04107, Germany
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Mainz, 55128, Germany
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Marburg, 35037, Germany
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Balassagyarmat, 2660, Hungary
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Budapest, 1033, Hungary
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Debrecen, 4032, Hungary
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Edelény, 3780, Hungary
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Gödöllő, 2100, Hungary
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Hajdúnánás, 4080, Hungary
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Pécs, 7635, Hungary
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Ashkelon, 7830604, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Rehovot, 7661041, Israel
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Eindhoven, 5623EJ, Netherlands
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Rotterdam, 3083 AN, Netherlands
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Zutphen, 7207 AE, Netherlands
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Auckland, 0626, New Zealand
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Christchurch, 8013, New Zealand
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Tauranga, 3110, New Zealand
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Wellington, 6021, New Zealand
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Bialystok, 15-044, Poland
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Bydgoszcz, 85-079, Poland
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Katowice, 40-648, Poland
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Krakow, 31-501, Poland
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Poznan, 60-693, Poland
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Tarnów, 33-100, Poland
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Wroclaw, 54-239, Poland
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Cape Town, 7700, South Africa
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Durban, 4001, South Africa
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Johannesburg, 2113, South Africa
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Tygervalley, 7530, South Africa
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Alzira, 46600, Spain
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Madrid, 28007, Spain
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Málaga, 29010, Spain
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Mérida, 06800, Spain
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Salamanca, 37007, Spain
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Santander, 39010, Spain
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Zaragoza, 50009, Spain
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Kaohsiung City, 807, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taipei, 110, Taiwan
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Taipei, 114, Taiwan
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Taoyuan, 333, Taiwan
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Bradford, BD9 6RJ, United Kingdom
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Bristol, BS105NB, United Kingdom
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Edinburgh, EH16 4SA, United Kingdom
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London, EC1A 7BE, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigational product only will be prepared and administrated by unmasked personnel.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2020
First Posted
November 16, 2020
Study Start
December 14, 2020
Primary Completion
May 30, 2023
Study Completion
November 13, 2023
Last Updated
February 27, 2025
Results First Posted
February 27, 2025
Record last verified: 2025-02
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 deidentified 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.