Uncontrolled moderate-to-severe asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Aged 18 to 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 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
Exclusion 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; • NT-proBNP level greater than the upper limit of the laboratory reference range during screening. • An LVEF 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A To assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma.;Secondary Objective: Part A To further assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma. Objectives common to Part A and Part B To assess the PK of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma. To assess the immunogenicity of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma. To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe asthma. To assess the effect of MEDI3506 compared with placebo on health status in adult participants with uncontrolled moderate-to-severe asthma. To assess the effect of MEDI3506 compared with placebo on CompEx in adult participants with uncontrolled moderate-to-severe asthma. To assess the effect of MEDI3506 compared with placebo on concentration of FeNO in adult participants with uncontrolled moderate-to-severe asthma. Refer to the protocol for the full list.;Primary end point(s): Part A The effect of MEDI3506 compared with placebo on lung function, as measured in clinic, change from baseline to Week 16 in pre-BD FEV1 (L).;Timepoint(s) of evaluation of this end point: Part A Baseline to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A • As measured in clinic, change from baseline to weeks 8 and 16 in postBD FEV1 (L). Endpoints common to Part A and B 1. Serum MEDI3506 concentration-time profiles during the intervention and follow-up periods. 2. Anti-drug antibody during the intervention and follow-up periods. 3. Change from baseline to Week 16 in asthma control questionnaire-6 (ACQ-6) score. Proportion of participants with a decrease in ACQ-6 score of = 0.5 from baseline to Week 16. Proportion of participants achieving ACQ-6 well controlled status (defined as ACQ-6 score = 0.75 at Week 16). 4. Change from baseline to Week 16 in St George’s respiratory questionnaire score (SGRQ). Proportion of participants with a decrease in SGRQ total score of = 4 points from baseline to Week 16. 5. Time to first CompEx event based on the period from baseline to Week 16. CompEx annualised event rate. 6. Percent change from baseline to Week 16 in concentration of FeNO in exhaled breath.;Timepoint(s) of evaluation of this end point: Part A From baseline to weeks 8 and 16. Timepoints common to Part A and B 1. Serum MEDI3506 concentration - During the intervention and follow-up periods 2. Anti-drug antibody - During the intervention and follow-up periods 3. ACQ-6 - Week 16 4. SGRQ - Week 16 5. CompEx - Week 16 6. FeNO - Week 16 | — |
Countries
Argentina, Germany, Hungary, Poland, South Africa, United Kingdom, United States
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed