A Phase 3 study to evaluate the Efficacy and Safety on Tralokinumab in Adults and Adolescents with oral corticosteroid dependent asthma.

Phase 1

• Conditions: Asthma; MedDRA version: 18.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001391-54-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-19
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age 12 to 75 years
2. Documented physician-diagnosed asthma.
3. Documented treatment with Inhaled Corticosteroid (ICS) at a total daily dose corresponding to =500µg fluticasone propionate dry powder formulation equivalents and a LABA.
4. Receiving Oral Corticosteroid (OCS) for the treatment of asthma.
5. Morning pre-BD FEV1 value = 40 and <80% (<90% for patients 12 to 17 years of age) of their predicted normal value (PNV).
6. Post-BD reversibility of =12% and =200 mL in FEV1.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Clinically important 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