A clinical trial to investigate the effects of tralokinumab, a drug used in clinical research, in adults with uncontrolled, severe asthma, a disease that causes variable and recurring inflammation of the airways leading to difficulty in breathing.

• Conditions: Asthma; 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]

• Registration Number: EUCTR2011-001360-21-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-08
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1) Age 18-75 years of age at the time of screening (Visit 1).
2) Written informed consent
3) Body mass index (BMI) between 16-40 kg/m2 at Visit 1.
4) Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 and
EITHER
- Proof of postbronchodilator reversibility of FEV1 = 12% and = 200 mL to a
SABA documented within 36 months prior to Visit 1; OR
- Proof of a positive response to a methacholine (PC20 = 8 mg/mL), histamine or mannitol challenge documented within 36 months prior to Visit 1; OR
- A postbronchodilator increase in FEV1 = 12% and = 200 mL at Visit 1.
5) Subjects must have received an asthma controller regimen consistent with that
described at Step 4 or 5 of the GINA guidelines (GINA, 2009) for at least 6 of the
12 months prior to Visit 1 and must have used physician prescribed high-dose ICS in
combination with LABA for at least 30 days prior to Visit 1
6) For subjects receiving an alternative combination of ICS/LABA prior to Visit 1, a
willingness to switch to fluticasone/salmeterol either as a DPI at a dose of 500/50 µg,
one inhalation twice per day, or as an MDI at a dose of 230 µg/21 µg, 2 inhalations
twice per day, once eligibility has been confirmed at Visit 2.
7) Where applicable, the dose of other asthma controller medications (leukotriene
modifiers, theophylline, secondary ICS, OCS, or cromones) must have been stable for at least 30 days prior to Visit 1.
8) Subjects must have a history of at least 2 but no more than 6 documented asthma
exacerbation events within the 12 months prior to Visit 1.
9) At both Visits 1 and 4, subjects must have at least one of the following; a morning
prebronchodilator FEV1 value of between 40% and 80% predicted or an ACQ-6 score
for the preceding week of = 1.5.
10) A chest x-ray taken during the screening period or within the 12 months before
Visit 1 that, according to the investigator, is normal for an asthmatic subject and
excludes significant alternative respiratory disease.
11) Females of childbearing potential who are sexually active with a nonsterilized male
partner must use highly effective contraception from screening, and must agree to
continue using such precautions through Week 75 of the study.
- A highly effective method of contraception is defined as one that results in a
low failure rate (ie, less than 1% per year) when used consistently and
correctly.
12) 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 (see Table 4.2.1-1) from Day 1 through Week 75.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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) Individuals who are legally institutionalized.
4) Subjects unable to demonstrate acceptable inhaler and peak flow meter/spirometry
techniques as judged by the investigator.
5) Any concomitant respiratory disease that in the opinion of the investigator and/or
medical monitor will interfere with the evaluation of the investigational product.
6) Concurrent enrollment in another clinical study where the subject is receiving an
investigational product.
7) Previous receipt of tralokinumab.
8) Receipt of any marketed or investigational biologic agent within 4 months or
5 half-lives prior to Visit 1, whichever is longer
9) Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior
to Visit 1, whichever is longer
10) Subjects who have received a live attenuated vaccine within 4 weeks prior to Visit 1.
11) Use of systemic immunosuppressive medication within 3 months prior to Visit 1.
12) Current use of any excluded medications listed in Section 4.6.2 of protocol.
13) Occurrence of an asthma exacerbation event requiring a burst of systemic
corticosteroids from 30 days prior to Visit 1, up to and including Visit 4.
14) Known history of allergy or reaction to any component of the investigational product
formulation or history of anaphylaxis following any biologic therapy.
15) Known exposure to inhaled occupational agents or fumes with an established
diagnosis of occupational asthma.
16) Current tobacco smoking (smoking must have stopped for = 3 months prior to screening) or a history of tobacco smoking = 10 pack-years.
17) Previous medical history or evidence of an uncontrolled intercurrent illness that in the
opinion of the investigator and/or medical monitor may compromise the safety of the
subject in the study or interfere with evaluation of the investigational product or
reduce the subject’s ability to participate in the study.
18) Any clinically relevant abnormal findings in physical examination, electrocardiogram
(ECG), vital signs, hematology, clinical chemistry, or urinalysis during screening/runin
period, which in the opinion of the investigator or medical monitor may
compromise the safety of the subject in the study or interfere with evaluation of the
investigational product or reduce the subject’s ability to participate in the study.
19) Evidence of active liver disease, including jaundice or aspartate transaminase, alanine
transaminase, or alkaline phosphatase greater than twice the upper limit of normal.
20) History of a clinically significant infection from 30 days prior to Visit 1, up to and including Visit 4.
21) Subjects who in the opinion of the investigator have evidence of active TB, either
treated or untreated, or latent TB without completion of an appropriate course of
treatment or appropriate ongoing prophylactic treatment.
22) A history of an untreated systemic helminth parasitic infestation; diagnosis of a
helminth parasitic infestation within 6 months prior to Visit 1; history of living with a
person known to have had a helminth parasitic infestation within 12 months prior to
Visit 1.
23) History of chronic alcohol or drug abuse within 12 months of Visit 1, or any condition
associated with poor compliance as judged by the investigator.
24) History of a

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified