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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01402986
First received: July 21, 2011
Last updated: March 20, 2014
Last verified: March 2014
  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:


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: 689
Study Start Date: August 2011
Study Completion Date: February 2014
Primary Completion Date: June 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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 93 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 20, 2014
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 Pública 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 September 30, 2014