A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Inadequately Controlled Asthma

Treatments: Biological: Tralokinumab open-label

Study type: Interventional

Funder types: Industry

Identifiers

NCT02902809

D2210C00029

Details and patient eligibility

About

A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist

Full description

This is a 52-week, open-label, multi-centre study designed to evaluate the safety of tralokinumab in a fixed 300 mg dose every 2 weeks, administered subcutaneously in adults and adolescents with indequately controlled asthma on medium to high dose inhaled corticosteroid plus long acting β-2 antagonist. Approximately 26 Japanese subjects will be recruited to receive 22 completed.

Enrollment: 28 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 12 - 75 yrs
2. Documented physician-diagnosed asthma
3. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA)
4. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of their Predicted Normal Value (PNV)
5. Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Open-label study to evaluate safety

Experimental group

Description:

A fixed 300 mg dose every 2 weeks (Q2W) of tralokinumab administered subcutaneously in subjects with inadequately controlled asthma on medium to high-dose of inhaled corticosteroid plus long-acting β2-agonist.

Treatment:

Biological: Tralokinumab open-label