A Phase 3 study to evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with severe asthma that is not controlled.

Phase 1

• Conditions: Severe uncontrolled Asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-003078-15-AT
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-02
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1060

Inclusion Criteria

1) Provision of signed and dated informed consent prior to any mandatory study specific procedures, sampling and analyses.
2) Subjects must be 12 to 80 years of age inclusive at the time of signing the informed consent form.
3) Documented physician-diagnosed asthma for at least 12 months.
4) Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.
5) Documented treatment with a total daily dose of either medium or high dose ICS (= 500 ug fluticasone proprionate dry powder formulation equivalent total daily dose) for at least 3 months.
6) At least one additional maintenance asthma controller medication is require according to standard practice of care, eg. LABA, LTRA, theophylline, LAMA, cromones etc. Use of additional asthma controller medications must be document for at least 3 months.
7) Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 years of age).
8) Evidence of asthma as documented by either i) Documented historical reversibility of FEV1 =12% and =200 mL in the previous 12 months OR ii) Post-BD (albuterol/salbutamol) reversibility of FEV1 =12% and =200 mL during screening.
9) ACQ-6 score =1.5 at screening and randomization.
10) Documented history of at least 2 asthma exacerbation events within 12 months.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 845
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135

Exclusion Criteria

1) Any clinically important pulmonary disease other than asthma.
2) History of cancer.
3) History of clinically significant infection, including upper (URTI) or lower respiratory tract infection (LRTI), requiring treatment with antibiotics or antiviral medications finalized <2 weeks before Visit 1 or during the run-in period.
4) Current smokers or subjects with smoking history >=10 pack-years and subjects using vaping products, including electronic cigarettes. Former smokers with a smoking history of <10 pack years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1.
5) History or chronic alcohol or drug abuse within 12 months prior to Visit 1.
6) Tuberculosis requiring treatment within 12 months prior to Visit 1.
7) History of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at Visit 1, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
8) History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biological therapy.
9) Subject randomized in the current study or previous tezepelumab studies.
10) Treatment with the following medications within the last 12 weeks prior to randomization: Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, etc) except for OCS used in the treatment of asthma/asthma exacerbations.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified