A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Asthma

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 689
• Participant gender: Both

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Antibodies, Monoclonal
• Last Updated: 2014-03-20

Criteria

Inclusion Criteria:

1. Age 18-75 years

2. Body mass index (BMI) between 16-40 kg/m2 at Visit 1.

3. Uncontrolled severe asthma

4. A chest x-ray with no abnormality

5. Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1

6. Nonsterilized males or sterilized males who are ≤ 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:

1. 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.

2. Pregnant or breastfeeding women

3. Any other respiratory disease

4. Previously taken tralokinumab (the study drug)

5. Current smoker or a history of smoking which would be more than 1 pack per day for 10 years

6. Known immune deficiency

7. History of cancer

8. Hepatitis B, C or HIV

9. Any disease which may cause complications whilst taking the study drug