A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma

NCT ID: NCT00640016

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-07-31

Brief Summary

To investigate the effects of CAT-354 on airway hyper-responsiveness (AHR) in uncontrolled asthma.

Detailed Description

This is a randomized, stratified, double-blind, placebo-controlled, multicenter, multinational study in subjects with uncontrolled asthma despite optimal treatment. Following confirmation of eligibility, subjects will be randomly assigned on Day 0, to 1 of 4 dose groups 1 mg/kg CAT-354, 5 mg/kg CAT-354, 10 mg/kg CAT or Placebo to match all doses of CAT-354. Doses of the assigned treatment will be administered on three occasions 28 days apart. Subjects will be assessed for efficacy, including airway hyper-responsiveness (AHR), safety, pharmacokinetic, pharmacodynamics and immunogenicity until Day 84 post-first dose.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.

CAT-354 1 mg/kg

CAT-354 1 milligram per kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

Group Type: EXPERIMENTAL

CAT-354 1 mg/kg

Intervention Type: BIOLOGICAL

CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

CAT-354 5 mg/kg

CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

Group Type: EXPERIMENTAL

CAT-354 5 mg/kg

Intervention Type: BIOLOGICAL

CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

CAT-354 10 mg/kg

CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56

Group Type: EXPERIMENTAL

CAT-354 10 mg/kg

Intervention Type: OTHER

CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

Interventions

Placebo

Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.

Intervention Type: OTHER

CAT-354 1 mg/kg

CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

Intervention Type: BIOLOGICAL

CAT-354 5 mg/kg

CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

Intervention Type: BIOLOGICAL

CAT-354 10 mg/kg

CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

Intervention Type: OTHER

Other Intervention Names

Tralokinumab; Tralokinumab; Tralokinumab

Eligibility Criteria

Inclusion Criteria

• Signed and dated written informed consent is obtained prior to any study related procedure taking place
• Women either infertile (example [e.g.], hysterectomized, sterile or post-menopausal with amenorrhea of least 1 year duration) or who are practicing an acceptable form of birth control
• Uncontrolled (refractory) asthma despite treatment with a minimum dose of 800 microgram (mcg) beclomethasonedipropionate or equivalent inhaled corticosteroid per day plus 1 or more additional controller, that is, long-acting beta-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable
• A forced expiratory volume in 1 second (FEV1) acceptable for airway hyper-responsiveness (AHR) challenge tests (greater than 60 percent of predicted normal) on the challenge days
• A provocative concentration of methacholine causing a 20 percent fall in FEV1 (PC20) less than 4 milligram per milliliter (mg/mL)
• Aged 18-80 years
• A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities
• Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
• Body weight of less than 130 kilogram (kg)
• No other clinically significant abnormality on history and clinical examination
• Able to comply with the requirements of the protocol.

Exclusion Criteria

• Experienced a severe exacerbation within 28 days preceding Day -28/-14 to Day 0
• Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Day -28/-14 to Day 0
• Subjects with a history of allergic rhinitis, seasonal allergy or esophagitis must be optimally controlled and remain on a stable treatment regimen during the study
• Participation in another study within 5 half-lives or 3 months of the start of this study, whichever is the longer
• Lower respiratory tract infection within 6 weeks of Day -28/-14 to Day 0
• Current smokers or ex-smokers with greater than 10 pack-years
• Blood donation (more than 550 mL) in the previous 2 months
• Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse
• Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis
• Concurrent medication from Day -28/-14 to Day 0 (Screening visit) and for the duration of the study with any of the prohibited medications
• Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
• systolic blood pressure greater than 200 millimeters of mercury (mmHg), or diastolic blood pressure greater than 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Day -28/-14 to Day 0, or who have a known aneurysm
• Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Day -28/-14 to Day 0
• Subjects with a history of allergic rhinitis, seasonal allergy or esophagitis must be optimally controlled and remain on a stable treatment regimen during the study
• Any factor which, in the opinion of the Investigator, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol (that is, inability to complete study diary, perform peak expiratory flow (PEF) measurements)
• The subject's primary care physician recommends the subject should not take part in the study
• Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge Antibody Technology

OTHER

Sponsor Role: collaborator

PRA Health Sciences

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Mayer, M.D.

Role: STUDY_DIRECTOR

PRA Health Sciences

Locations

St. Vincents Hospital, Thoracic Medicine Unit

Darlinghurst, New South Wales, Australia

Respiratory Medicine Department, Mater Adult Hospital,

South Brisbane, Queensland, Australia

Princess Alexandria Hospital, Dept of Respiratory Medicine

Woolloongabba, Queensland, Australia

Eastern Clinical Research Unit

Box Hill, Victoria, Australia

Monash Medical Centre, Dept Respiratory Medicine.

Clayton, Victoria, Australia

Dep of Respiratory & Sleep Medicine, Western Hospital

Footscray, Victoria, Australia

Respiratory & Sleep Medicine, Royal Melbourne Hospital

Parkville, Victoria, Australia

Lung Institute WA, Sir Charles Gardner Hospital

Nedlands, Western Australia, Australia

WA Lung Research, Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Evangelische Lungenklinik Berlin - Kardiologie/Pneumologie - 1.OG, Haus 23

Berlin, , Germany

Med. Klinik m. S. Infektiologie und Pneumologie, Charite - Universitätsmedizin Berlin

Berlin, , Germany

Lungen und Bronchialheikunde

Bonn, , Germany

Praxis für Lungen-und Bronchialheilkunde, Allergologie und Umweltmedizin

Bonn, , Germany

Rheinische Friedrich-Wilhelms-Universität, Medizinische Klinik und Poliklinik II, Innere Medizin

Bonn, , Germany

Internistisches Facharztzentrum Stresemannallee

Frankfurt, , Germany

Universitätsklinikum Magdeburg Fachbereich Pneumologie

Magdeburg, , Germany

Universitätsklinikum Mainz, Klinische Forschung Pneumologie, III. med. Klinik

Mainz, , Germany

Universitätsklinikum Münster Klinik und Poliklinik für Dermatologie

Münster, , Germany

Universität Rostock, Medizinische Fakultät Klinik und Poliklinik für Innere Medizin

Rostock, , Germany

Johanniter-Krankenhaus im Fläming gGmbH, Pneumologie

Treuenbrietzen, , Germany

Academisch Medisch Centrum

Amsterdam, , Netherlands

ISPL Centrum Medyczne

Bialystok, , Poland

Prywatny Gabinet Internistyczno-Alergologiczny

Bialystok, , Poland

Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej Akademii Medycznej, Klinika Pneumologii

Katowice, , Poland

Niepubliczny Zakład Opieki Zdrowotnej Atopia

Krakow, , Poland

Uniwersytecki Szpital Kliniczny nr 1 Im. Norberta Barlickiego w Łodzi

Lodz, , Poland

Szpital ZOZ Lubin Oddzial Alergologiczny i Chorob Wewnetrznych

Lubin, , Poland

Wojewodzki Szpital Specjalistyczny, Poradnia Alergologiczna

Lublin, , Poland

Alergopneuma Przychodnia Alergologiczno-Pulmonologiczna Marek Michnar i wsp.

Lublin, , Poland

Instytut Gruzlicy i Chorob Pluc

Warsaw, , Poland

Wojewódzki Szpital Specjalistyczny w Zgierzu

Zgierz, , Poland

Belfast City Hospital

Belfast, , United Kingdom

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Gartnavel General Hospital

Glasgow, , United Kingdom

University Hospitals of Leicester NHS Trust, Glenfield Hospital

Leicester, , United Kingdom

Royal Brompton Hospital

London, , United Kingdom

University Hospital of South Manchester NHS Foundation Trust

Manchester, , United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Royal Gwent Hospital

Newport, , United Kingdom

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Lister Hospital

Stevenage, Hertfordshire, , United Kingdom

Countries

Australia; Germany; Netherlands; Poland; United Kingdom

Other Identifiers

2007-002090-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAT-354-0603

Identifier Type: -

Identifier Source: org_study_id