A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

MedImmune

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Biological: Tralokinumab 300 mg, Q2W; Other: Placebo Q2W; Biological: Tralokinumab 300 mg, Q2/4W; Other: Placebo, Q2/4W

Study type: Interventional

Funder types: Industry

Identifiers

NCT01402986

2011-001360-21 (EudraCT Number)

CD-RI-CAT-354-1049

Details and patient eligibility

About

The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

Full description

Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in improved control of asthma. This study will determine whether the addition of tralokinumab to standard asthma medications results in a reduced rate of asthma exacerbations in subjects with severe asthma.

Enrollment: 689 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75 years
• Body mass index (BMI) between 16-40 kilogram per square meter (kg/m^2) at Visit 1
• Uncontrolled severe asthma
• A chest x-ray with no abnormality
• Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from Day 1
• Non-sterilized males or sterilized males who are less than or equal to (=<) 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception

Exclusion criteria

• 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
• Any other respiratory disease
• Previously taken tralokinumab (the study drug)
• Current smoker or a history of smoking which would be more than 1 pack per day for 10 years
• Known immune deficiency
• History of cancer
• Hepatitis B, C or Human Immuno-deficiency Virus (HIV)
• Any disease which may cause complications whilst taking the study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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689 participants in 4 patient groups, including a placebo group

Placebo, Q2W - Cohort 1

Placebo Comparator group

Description:

Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

Treatment:

Other: Placebo Q2W

Tralokinumab 300 mg, Q2W - Cohort 1

Experimental group

Description:

Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

Treatment:

Biological: Tralokinumab 300 mg, Q2W

Placebo, Q2/4W - Cohort 2

Placebo Comparator group

Description:

Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

Treatment:

Other: Placebo, Q2/4W

Tralokinumab 300 mg, Q2/4W - Cohort 2

Experimental group

Description:

Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

Treatment:

Biological: Tralokinumab 300 mg, Q2/4W