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

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Tralokinumab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Asthma Exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
To compare the asthma exacerbation rate in participants treated with tralokinumab versus placebo

Secondary Outcome Measures:

safety and tolerability [ Time Frame: Day 1 - Week 75 ] [ Designated as safety issue: Yes ]
Safety and tolerability of tralokinumab
Pharmacokinetics of tralokinumab [ Time Frame: Day 1 - Week 75 ] [ Designated as safety issue: 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 [ Time Frame: Day 1 - Week 52 ] [ Designated as safety issue: 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 [ Time Frame: Week 2 - Week 75 ] [ Designated as safety issue: No ]
Effect of tralokinumab on patient reported outcomes as measured by ACQ-6, EQ-5D, and AQLQ(S)

Enrollment:	452
Study Start Date:	October 2011
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cohort 1 195 patients randomised 2:1 (tralokinumab high dose : placebo)	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
Active Comparator: Cohort 2 195 patients randomised 2:1 (tralokinumab low dose: placebo)	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

Detailed 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 participants with severe asthma

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-75 years
Body mass index (BMI) between 16-40 kg/m2 at Visit 1.
Uncontrolled severe asthma
A chest x-ray with no abnormality
Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1
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:

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 HIV
Any disease which may cause complications whilst taking the study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402986

Show 122 Study Locations

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:	Edward Piper, MBBS	Sponsor GmbH
Principal Investigator:	Christopher Brightling	Institute for Lung Health

More Information

No publications provided

Responsible Party:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT01402986 History of Changes
Other Study ID Numbers:	CD-RI-CAT-354-1049, 2011-001360-21
Study First Received:	July 21, 2011
Last Updated:	March 7, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Russia: Ministry of Health of the Russian Federation South Korea: Korea Food and Drug Administration (KFDA) Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee United States: Food and Drug Administration United States: Institutional Review Board Germany: Federal Institute for Vaccines and Biomedicines Philippines : Food and Drug Administration Canada: Therapeutic Products Directorate Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Mexico: Federal Commission for Protection Against Health Risks Chile: Instituto de Salud Publica de Chile Brazil: Agência Nacional de Vigilância Sanitária - ANVISA Czech Republic: State Institute for Drug Control Japan: Product Development and Management Association Poland: The office for registration of medicinal products, medical devices and biocidal products

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013