Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids

NCT ID: NCT02449473

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-29
• Study Completion Date: 2017-06-21

Brief Summary

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid.

Detailed Description

This is a multicentre, randomized, double-blind, parallel group, placebo-controlled, phase 2 study to designed evaluate the effect of a 300 mg dose of tralokinumab administered subcutaneously every 2 weeks on airway inflammation in adults with asthma inadequately controlled on inhaled corticosteroids (ICS) with or without other controllers. Approximately 80 subjects will be randomized. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 12 week treatment period.

Conditions

Asthma

Study Design

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

Study Groups

Tralokinumab Dose Regimen

Tralokinumab Subcutaneous Injection

Group Type: EXPERIMENTAL

Tralokinumab

Intervention Type: BIOLOGICAL

Subcutaneous Injection

Placebo Dose Regimen

Placebo Subcutaneous Injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Subcutaneous Injection

Interventions

Tralokinumab

Subcutaneous Injection

Intervention Type: BIOLOGICAL

Placebo

Subcutaneous Injection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 75 years

2. Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)

3. Documented treatment with an asthma controller regimen requiring treatment with ICS (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)

4. Additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.

5. At enrolment (v1) the subject must have a predicted normal value (PNV) for the pre-bronchodilator (BD) FEV1>50% and more than 1L.

6. Post-BD reversibility in FEV1 of ≥12% and ≥200 mL at enrolment (v1).

Exclusion Criteria

1. History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung 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: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Brightling, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Lung Health, United Kingdom

Locations

Research Site

Vancouver, British Columbia, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Québec, Quebec, Canada

Research Site

Aalborg, , Denmark

Research Site

Århus C, , Denmark

Research Site

Hvidovre, , Denmark

Research Site

København NV, , Denmark

Research Site

Odense C, , Denmark

Research Site

Belfast, , United Kingdom

Research Site

Glasgow, , United Kingdom

Research Site

Leicester, , United Kingdom

Research Site

London, , United Kingdom

Research Site

Manchester, , United Kingdom

Research Site

Nottingham, , United Kingdom

Research Site

Southampton, , United Kingdom

Countries

Canada; Denmark; United Kingdom

References

Diver S, Sridhar S, Khalfaoui LC, Russell RJ, Emson C, Griffiths JM, de Los Reyes M, Yin D, Colice G, Brightling CE. Feno differentiates epithelial gene expression clusters: Exploratory analysis from the MESOS randomized controlled trial. J Allergy Clin Immunol. 2022 Oct;150(4):830-840. doi: 10.1016/j.jaci.2022.04.024. Epub 2022 May 7.

Reference Type: DERIVED

PMID: 35537502 (View on PubMed)

Russell RJ, Chachi L, FitzGerald JM, Backer V, Olivenstein R, Titlestad IL, Ulrik CS, Harrison T, Singh D, Chaudhuri R, Leaker B, McGarvey L, Siddiqui S, Wang M, Braddock M, Nordenmark LH, Cohen D, Parikh H, Colice G, Brightling CE; MESOS study investigators. Effect of tralokinumab, an interleukin-13 neutralising monoclonal antibody, on eosinophilic airway inflammation in uncontrolled moderate-to-severe asthma (MESOS): a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. Lancet Respir Med. 2018 Jul;6(7):499-510. doi: 10.1016/S2213-2600(18)30201-7. Epub 2018 May 21.

Reference Type: DERIVED

PMID: 29793857 (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

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Related Info

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3064&filename=d2210c00014-csp-Redacted2019.pdf

Related Info

Other Identifiers

D2210C00014

Identifier Type: -

Identifier Source: org_study_id