Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma

• Status: Recruiting
• Trial end date: 2022-08-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

INCLUSION CRITERIA

• Aged 18 to < 65 years of age

• 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.

• 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 < 35 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 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.