Severe Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Tezepelumab via APFS
Product Code: MDI9929 anti-TSLP mAb (AMG157)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tezepelumab
CAS Number: 1572943-0
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: • Age 18-80 years. • Documented physician diagnosed asthma requiring continuous treatment with high-dose ICS plus a LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers. • Documented long-term OCS therapy for asthma, equivalent to a daily dose of at least 5 mg and up to 40 mg of prednisone/prednisolone for at least 3 continuous months directly preceding Visit 1. • Participant should be on a stable OCS dose for at least 4 weeks prior to Visit 1. • Documented history of at least 1 asthma exacerbation event within 12 months prior to Visit 1. Other inclusion criteria per protocol apply. 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 255 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: Main exclusion criteria: • Pulmonary disease or systemic diseases, other than asthma associated with elevated peripheral EOS counts. • Any disorder or major physical impairment that is not stable and could affect the safety of the participant throughout the study, influence the findings of the study or the interpretation, or impede the participant's ability to complete the entire duration of study. • History of cancer. • History of a clinically significant infection requiring treatment with antibiotics or antiviral medications finalised 1 day during the conduct of the study. • Coexistent inflammatory conditions for which long-term OCS doses are part of their maintenance treatment. • Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational nonbiologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1. Participants enrolled in current or previous tezepelumab studies will not be included. • Concurrent enrolment in another clinical study involving an IP. • Treatment with systemic immunosuppressive/immunomodulating drugs, except for OCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1. • History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy. • Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. • Pregnant, breastfeeding, or lactating women. Other exclusion criteria per protocol apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the ability of tezepelumab 210 mg subcutaneous (SC) to reduce prescribed OCS dose (= 5 mg/day) without loss of asthma control in adult participants with OCS-dependent asthma.;Secondary Objective: 1. To assess the ability of tezepelumab 210 mg SC to prevent asthma exacerbations in adult participants with OCS-dependent asthma while OCS dose reduction. 2. To assess the ability of tezepelumab 210mg SC to allow reduction of the prescribed OCS dose without loss of asthma control. 3. To assess the ability of tezepelumab to improve lung function. 4. To assess the ability of tezepelumab to improve asthma control. 5. To assess the ability of tezepelumab to improve asthma related quality of life.;Primary end point(s): • Proportion of participants who discontinued OCS without loss of asthma control at Week 28 and Week 52 • Proportion of participants who reduced daily prescribed maintenance OCS dose to = 5 mg/day without loss of asthma control at Week 28 and Week 52;Timepoint(s) of evaluation of this end point: • Week 28 and Week 52 • Week 28 and Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. • The AAER over 28 weeks and over 52 weeks • Rate of asthma exacerbation associated with hospitalisation or emergency room (ER) visit over 28 weeks and over 52 weeks • Rate of asthma exacerbation associated with hospitalisation over 28 weeks and over 52 weeks • Proportion of participants who did not experience an exacerbation over 28 weeks and over 52 weeks • Proportion of participants who did not experience an exacerbation associated with hospitalisation or ER visit over 28 weeks and 52 weeks • Proportion of participants who did not experience an exacerbation associated with hospitalisation over 28 weeks and over 52 weeks 2. • Proportion of participants with = 50% reduction from baseline in daily maintenance OCS dose at Week 28 and Week 52 • Categorised percent reduction from baseline in the daily maintenance OCS dose (categories: = 90% to = 100% reduction, = 75% to 0% to < 50% reduction, no change or any increase) at Week 28 and Week 52 • Absolute and percent change from baseline in daily maintenance OCS dose at Week 28 and Week 52 3. • Change from baseline in post-bronchodilator (post-BD) FEV1 at Week 28 and Week 52 4. • Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) at Week 28 and Week 52 5. • Change from baseline in standardised Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]+12) total score at Week 28 and Week 52 • Change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 28 and Week 52;Timepoint(s) of evaluation of this end point: All at Week 28 and Week 52 | — |
Countries
Argentina, Belgium, Bulgaria, France, Germany, Italy, Latvia, Lithuania, Mexico, Poland, Puerto Rico, Spain, United Kingdom, United States
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed