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Health Condition(s) or Problem
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Asthma
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Lay Summary
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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
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Drug; Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody (MAb) of the immunoglobulin G4 (IgG4) subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor; Cohort 1; Cohort 2
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Primary aim
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Asthma Exacerbation
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Secondary Aim
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safety and tolerability; Day 1 - Week 75; Yes; Safety and tolerability of tralokinumab; Pharmacokinetics of tralokinumab; Day 1 - Week 75; No; Pharmacokinetics of tralokinumab measured by Cmax, AUC, t1/2, CL after first dose Pharmacokinetics of tralokinumab measured by Cmax, AUC, t1/2, CL after multiple doses; Effect of tralokinumab on pulmonary function as measured by FEV1, FEV6, FVC, IC, and PEF; Day 1 - Week 52; No; To evaluate the effect of tralokinumab on FEV1: clinic spirometry, including pre- and post bronchodilator forced expiratory volume and and peak expiratory flow (PEF) and FEV1 measured at home.; Patient reported outcomes; Week 2 - Week 75; No; Effect of tralokinumab on patient reported outcomes as measured by ACQ-6, EQ-5D, and AQLQ(S)
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Not Recruiting
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Nation
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England
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Location
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Manchester, Leicester, Liverpool
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