A trial to investigate the safety of tralokinumab in adolescents, a product under investigation for the treatment of asthma

Conditions: MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Asthma

Registration Number: EUCTR2011-005503-33-PL

Lead Sponsor: MedImmune Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Age 12-17 years (inclusive)
•Weight > 30kg
•Asthma for a minimum of 6 months
•Effective birth control for both male and female participants in line with protocol details.

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 < 3 months
•Known immune deficiency
•History of cancer
•Hepatitis B, C or HIV
•Any disease which may cause complications whilst taking the study drug

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation (AUC(0-infinity); AUC(0-t)); dose-normalized AUC(0-infinity) (AUC(0-infinity)/D); Cmax; dose-normalized Cmax (Cmax/D); time to Cmax (Tmax); terminal-phase elimination half-life (t1/2); apparent clearance (CL/F); steady-state volume of distribution (Vss/F).;Timepoint(s) of evaluation of this end point: There will be 10 PK assessments from administration of investigational product up to, and including, Day 57.;Main Objective: To evaluate the pharmacokinetics of tralokinumab in adolescent subjects with asthma.;Secondary Objective: To evaluate the safety, tolerability and immunogenicity (IM) of tralokinumab.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the safety, tolerability and immunogenicity of tralokinumab.;Timepoint(s) of evaluation of this end point: There will be ongoing assessments of the safety, tolerability and immunogenicity of tralokinumab from administration of investigational product up to, and including, Day 57.