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Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma

NCT ID: NCT02281357

Last Updated: 2019-03-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-19

Study Completion Date

2017-09-07

Brief Summary

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A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent Asthma.

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Detailed Description

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This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 300 mg dose of tralokinumab administered subcutaneously every 2 weeks in adult and adolescent subjects with oral corticosteroid dependent asthma. Approximately120 subjects will be randomized globally. Subjects will receive tralokinumab or placebo, administered via subcutaneous injection at the study site, over a 40-week treatment period.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tralokinumab

Tralokinumab subcutaneous injection

Group Type EXPERIMENTAL

Tralokinumab

Intervention Type BIOLOGICAL

Tralokinumab dose

Placebo

Placebo subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo dose

Interventions

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Tralokinumab

Tralokinumab dose

Intervention Type BIOLOGICAL

Placebo

Placebo dose

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1\) Age 12-75 2) Documented physician-diagnosed asthma. 3) Documented treatment with ICS at a total daily dose corresponding to ≥500µg fluticasone propionate dry powder formulation and a LABA. 4) Subjects must have received OCS for the treatment of asthma for 6 months prior to Visit 1 and on a stable OCS dose between ≥7.5 to ≤30mg daily or daily equivalent for at least one month prior to enrolment (Visit 1) . 5) Pre-BD FEV1 value \<80% (\<90% for patients 12-17 yrs of age) of their PNV. 6) Post-BD reversibility of ≥12% in FEV1.

Exclusion Criteria

1\) Clinically important pulmonary disease other than asthma. 2) History of anaphylaxis following any biologic therapy. 3) Hepatitis B, C or HIV. 4) Pregnant or breastfeeding. 5) History of cancer. 6) Current tobacco smoking or a history of tobacco smoking for ≥10 pack-years. 7) Previous receipt of tralokinumab.
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William W Busse, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin School of Medicine and Public Health, Department of Medicine, Allergy & Immunology

Locations

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Research Site

New Haven, Connecticut, United States

Site Status

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Clearwater, Florida, United States

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St Louis, Missouri, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Monroeville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Anderson, South Carolina, United States

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Spartanburg, South Carolina, United States

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Boerne, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Richmond, Virginia, United States

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Brussels (Anderlecht), , Belgium

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Ghent, , Belgium

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Hasselt, , Belgium

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Leuven, , Belgium

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Woluwé-St-Lambert, , Belgium

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Grenoble, , France

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Lille, , France

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Lyon, , France

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Nantes, , France

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Pessac, , France

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Berlin, , Germany

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Berlin, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Mainz, , Germany

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München, , Germany

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München-Pasing, , Germany

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Amsterdam, , Netherlands

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Groningen, , Netherlands

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Leeuwarden, , Netherlands

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Bystra, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lubin, , Poland

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Ostrowiec Świętokrzyski, , Poland

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Rzeszów, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Dnipro, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Vinnytsia, , Ukraine

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Countries

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United States Belgium France Germany Netherlands Poland Ukraine

References

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Busse WW, Brusselle GG, Korn S, Kuna P, Magnan A, Cohen D, Bowen K, Piechowiak T, Wang MM, Colice G. Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma. Eur Respir J. 2019 Jan 31;53(2):1800948. doi: 10.1183/13993003.00948-2018. Print 2019 Feb.

Reference Type BACKGROUND
PMID: 30442714 (View on PubMed)

Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.

Reference Type DERIVED
PMID: 29536781 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2966&filename=d2210c00013-revised-csp-4_Redacted_PDFA.pdf

Related Info

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2966&filename=d2210c00013-sap-ed-3_redaction_proposed_Redacted_PDFA.pdf

Related Info

Other Identifiers

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D2210C00013

Identifier Type: -

Identifier Source: org_study_id

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