A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma

MedImmune

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Biological: Tralokinumab 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01592396

2011-005503-33 (EudraCT Number)

CD-RI-CAT-354-1054

Details and patient eligibility

About

The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.

Full description

Interleukin-13 (IL-13) is a pleiotropic cytokine that promotes inflammation, airways hyper-responsiveness (directly and through recruitment and activation of inflammatory cells), mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin E (IgE) synthesis and mast cell activation.Tralokinumab (CAT-354) is a human immunoglobulin G4 (IgG4) anti-IL-13 monoclonal antibody that has been shown to potently and specifically neutralize IL-13 in preclinical models.This study will evaluate the PK profile of a single dose of tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with asthma to be compared with the PK data from completed studies in adults.

Enrollment: 30 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age 12-17 years (inclusive)
• Weight greater than (>) 30 kilogram (kg)
• Asthma for a minimum of 6 months prior to Screening
• Effective birth control for both male and female participants in line with protocol details.
• Exclusion Criteria:
• Previously taken tralokinumab (the study drug)
• Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
• Pregnant or breastfeeding women
• Current smoker or cessation less than (<) 3 months prior to screening
• Known immune deficiency excluding asymptomatic selective immunoglobulin A
• History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive
• Any disease which may cause complications whilst taking the study drug.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Tralokinumab 300 mg

Experimental group

Description:

Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.

Treatment:

Biological: Tralokinumab 300 mg