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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402986
• Other study ID #: CD-RI-CAT-354-1049
• Secondary ID: 2011-001360-21
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2011
• Last updated: March 20, 2014
• Start date: August 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Russia: Ministry of Health of the Russian FederationSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardGermany: Federal Institute for Vaccines and BiomedicinesPhilippines : Food and Drug AdministrationCanada: Therapeutic Products DirectorateArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaMexico: Federal Commission for Protection Against Health RisksChile: Instituto de Salud Pública de ChileBrazil: Agência Nacional de Vigilância Sanitária - ANVISACzech Republic: State Institute for Drug ControlJapan: Product Development and Management AssociationPoland: The office for registration of medicinal products, medical devices and biocidal products
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: February 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Monte Grande
Argentina	Research Site	Ranelagh
Argentina	Research Site	Rosario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Chile	Research Site	Quillota
Chile	Research Site	Santiago
Chile	Research Site	Valparaiso
Chile	Research Site	Viña del Mar
Czech Republic	Research Site	Jindrichuv Hradec
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Rokycany
France	Research Site	Marseille Cedex 20
France	Research Site	Montpellier
France	Research Site	NANTES Cedex 1
France	Research Site	Paris
France	Research Site	Perpignan
France	Research Site	Pessac
France	Research Site	Strasbourg Cedex
Germany	Research Site	Berlin
Germany	Research Site	Frankfurt
Germany	Research Site	Lübeck
Germany	Research Site	Mainz
Japan	Research Site	Chuo-ku
Japan	Research Site	Fujisawa-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Habikino-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Itabashi-ku
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kagoshima-shi	Kagoshima
Japan	Research Site	Kahoku-gun
Japan	Research Site	Kishiwada-shi
Japan	Research Site	Kobe-shi
Japan	Research Site	Kurashiki-city	Okayama
Japan	Research Site	Kyoto-shi
Japan	Research Site	Maebashi-shi
Japan	Research Site	Morioka-shi
Japan	Research Site	Naka-gun
Japan	Research Site	Sagamihara-shi
Japan	Research Site	Sakaide-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sumida-ku
Japan	Research Site	Takatsuki-shi
Japan	Research Site	Tomakomai-shi
Japan	Research Site	Wakayama-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Bucheon-si
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
Mexico	Research Site	Culiacan
Mexico	Research Site	Guadalajara
Mexico	Research Site	México
Mexico	Research Site	Morelia
Mexico	Research Site	Santiago de Querétaro
Mexico	Research Site	Tampico
Mexico	Research Site	Villahermosa
Philippines	Research Site	Iloilo City
Philippines	Research Site	Lipa City
Philippines	Research Site	Quezon City
Poland	Research Site	Lódz
Poland	Research Site	Wroclaw
Poland	Research Site	Zabrze
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Vladikavkaz
Russian Federation	Research Site	Yekaterinburg
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Pamplona
Spain	Research Site	Sagunto(Valencia)
Spain	Research Site	Santander
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Manchester
United States	Research Site	Albany	Georgia
United States	Research Site	Centennial	Colorado
United States	Research Site	Cocoa	Florida
United States	Research Site	Fargo	North Dakota
United States	Research Site	Killeen	Texas
United States	Research Site	Miami	Florida
United States	Research Site	New Haven	Connecticut
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Rancho Mirage	California
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Upland	Pennsylvania
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Czech Republic,  France,  Germany,  Japan,  Korea, Republic of,  Mexico,  Philippines,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Exacerbation	To compare the asthma exacerbation rate in participants treated with tralokinumab versus placebo	52 weeks	No
Secondary	safety and tolerability	Safety and tolerability of tralokinumab	Day 1 - Week 75	Yes
Secondary	Pharmacokinetics of tralokinumab	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	Day 1 - Week 75	No
Secondary	Effect of tralokinumab on pulmonary function as measured by FEV1, FEV6, FVC, IC, and PEF	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.	Day 1 - Week 52	No
Secondary	Patient reported outcomes	Effect of tralokinumab on patient reported outcomes as measured by ACQ-6, EQ-5D, and AQLQ(S)	Week 2 - Week 75	No