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

Phase 1

• Conditions: Asthma; MedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-005614-35-BE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-24
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1140

Inclusion Criteria

1. Age 12 -75
2. Documented physician-diagnosed asthma.
3. Documented treatment with ICS at a total daily dose corresponding to =500µg fluticasone propionate dry powder formulation equivalents) and a LABA
4. Morning pre-BD FEV1 value of =40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV.
5. Post-BD reversibility of =12% and =200 mL in FEV1
6. ACQ-6 score =1.5
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 960
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for = 10 pack-years
7. Previous receipt of tralokinumab

Study & Design

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