Study to Assess the Efficacy and Safety of MEDI3506 in Adults with Uncontrolled Moderate-to-severe Asthma
- Conditions
- MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersncontrolled moderate-to-severe asthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-000789-40-DE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 228
• Aged 18 to < 65 years of age inclusive.
• History of = 1 asthma exacerbation in previous 12 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 at SV1, SV2, and SV4 (randomisation).
• Morning pre-BD FEV1 < 85% predicted normal at SV1.
•= 70% adherence (days) to eDiary completion both between SV1 and SV2 and in the 14 days preceding SV4.
- An adherent day requires completion of evening and subsequent morning diary between SV1 (evening assessment) and SV2 (morning assessment).
• = 70% adherence to background medication as assessed by eDiary entries both between SV1 and SV2 and in the 14 days preceding SV4.
• Participants must demonstrate ability to perform acceptable inhaler and spirometry techniques.
• Bodyweight = 40 kg and BMI < 35 kg/m2.
• For female participants of childbearing potential (see Appendix I for definition of childbearing potential):
- A negative serum pregnancy test at SV1.
- A negative urine pregnancy test at SV2 and prior to administration of study intervention at SV4 (randomisation).
• Abide by contraception requirements for males and females
• Provide informed consent
• Participants with documented evidence of asthma as defined in the protocol.
• Documented history of = 1 asthma exacerbation in 12 months prior to SV1 (see Section 8.1.5 for definitions of acceptable documentation and asthma exacerbation).
• Morning pre-BD FEV1 = 40% predicted normal and > 1 L at SV1.
For the full list of inclusion criteria, please refer to section 5.1 of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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;
• NT-proBNP level greater than the upper limit of the laboratory reference range during screening.
• 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.
For the full list of exclusion criteria, please refer to section 5.2 of the
protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method