A Phase 3 extension study designed to evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with severe, uncontrolled asthma on Inhaled Corticosteroids and at least one additional asthma controller

Phase 1

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

• Registration Number: EUCTR2018-002501-53-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 975

Inclusion Criteria

1) Provision of signed and dated informed consent form prior to any mandatory study specific procedures, sampling and analysis.

2) Negative urine pregnancy test for female subjects of childbearing potential prior to administration of IP at visit 1

3) Subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either predecessor study D5180C00007 or D5180C00009
Are the trial subjects under 18? yes
Number of subjects for this age range: 65
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 785
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

1) Any clinically important pulmonary disease other than asthma

2) Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator

3) Any history of chronic alcohol or drug abuse within 12 months prior to Visit 1

4) Current malignancy or malignancy that developed during a predecessor study

5) Patients who had a resection or treatment of in situ carcinoma of cervix during the predecessor study

6) Treatment with the following medications within the last 12 weeks prior to randomization: Systemic immunosuppressive/immunomodulating drugs except for OCS used for the treatment of asthma

7) Any important protocol deviations in either of the predecessor studies

8) Pregnant, breastfeeding, or lactating women

Study & Design

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