A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (STRATOS1)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Uncontrolled Asthma

Treatments: Other: Placebo; Biological: Tralokinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02161757

D2210C00007

Details and patient eligibility

About

A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

Full description

This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations.

Approximately 1140 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.

Enrollment: 1,207 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,207 participants in 4 patient groups, including a placebo group

Tralokinumab Dose Regimen 1

Experimental group

Description:

Tralokinumab subcutaneous injection

Treatment:

Biological: Tralokinumab

Placebo Dose Regimen 1

Placebo Comparator group

Description:

Placebo subcutaneous injection

Treatment:

Other: Placebo

Tralokinumab Dose Regimen 2

Experimental group

Description:

Tralokinumab subcutaneous injection

Treatment:

Biological: Tralokinumab

Placebo Dose Regimen 2

Placebo Comparator group

Description:

Placebo subcutaneous injection

Treatment:

Other: Placebo