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

NCT02281357 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: D2210C00013
• Study Type: interventional
• Target: 140
• Locations: 7 countries
• Sites: 51

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Reactive Airways; Repiratory Tract Disease; Obstructive Lung Disease; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in the Final Daily, Average, OCS Dose at Week 40 While Not Losing Asthma Control.

  The 40-week treatment period consisted of 3 phases: an induction phase (Week 0 to Week 12) where patients remained on their optimised OCS dose; an OCS reduction phase (Week 12 to Week 32) where OCS dose reduction could have started at Week 12 with the possibility of dose titration every 4 weeks to reach the lowest possible OCS dose; and a maintenance phase (Week 32 to Week 40) where patients remained on the OCS dose reached at Week 32 to demonstrate asthma control was maintained after achieving the lowest OCS dose. Criteria used to assess asthma control included lung function assessments (forced expiratory volume in 1 second and morning peak expiratory flow), night awakenings, and the use of rescue medication and systemic corticosteroids. The least squares (LS) mean percent change from baseline in average daily OCS dose is presented. The final daily percent change from baseline was defined as {(Final daily average dose - baseline daily average dose)/baseline daily average dose}\*100%.

  Baseline (Week 0) and Week 40

Secondary Outcomes (3)

• The Number of Patients With Final Daily Average OCS Dose ≤5 mg at Week 40.

  At Week 40

• The Number of Patients With ≥50% Reduction in Final Average Daily OCS Dose at Week 40.

  At Week 40

• Annual Asthma Exacerbation Rate (AAER) up to Week 40.

  Baseline (Week 0) up to Week 40

Study Arms (2)

Tralokinumab

EXPERIMENTAL

Tralokinumab subcutaneous injection

Biological: Tralokinumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection

Other: Placebo

Interventions

Tralokinumab BIOLOGICAL

Tralokinumab dose

Tralokinumab

Placebo OTHER

Placebo dose

Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (51)

Research Site

New Haven, Connecticut, 06520, United States

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Clearwater, Florida, 33765, United States

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St Louis, Missouri, 63141, United States

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Rochester, New York, 14618, United States

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The Bronx, New York, 10461, United States

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Durham, North Carolina, 27705, United States

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Monroeville, Pennsylvania, 15146, United States

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Philadelphia, Pennsylvania, 19140, United States

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Anderson, South Carolina, 29621, United States

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Spartanburg, South Carolina, 29303, United States

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Boerne, Texas, 78006, United States

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Dallas, Texas, 75246, United States

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San Antonio, Texas, 78212, United States

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Tyler, Texas, 75708, United States

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Richmond, Virginia, 23225, United States

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Brussels (Anderlecht), 1070, Belgium

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Ghent, 9000, Belgium

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Hasselt, 3500, Belgium

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Leuven, 3000, Belgium

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Woluwé-St-Lambert, 1200, Belgium

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Grenoble, 38043, France

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Lille, 59037, France

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Lyon, 69317, France

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Nantes, 44093, France

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Pessac, 33604, France

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Berlin, 10717, Germany

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Berlin, 10969, Germany

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Frankfurt, 60596, Germany

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Hamburg, 22299, Germany

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Hanover, 30625, Germany

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Mainz, 55131, Germany

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München, 80331, Germany

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München-Pasing, 81241, Germany

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Amsterdam, 1105 AZ, Netherlands

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Groningen, 9728 NT, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Bystra, 43-360, Poland

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Krakow, 31-011, Poland

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Krakow, 31-209, Poland

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Lodz, 90-141, Poland

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Lubin, 59-300, Poland

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Ostrowiec Świętokrzyski, 27-400, Poland

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Rzeszów, 35-051, Poland

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Wroclaw, 50-220, Poland

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Wroclaw, 53-301, Poland

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Dnipro, 49007, Ukraine

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Kharkiv, 61002, Ukraine

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Kharkiv, 61035, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 04201, Ukraine

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Vinnytsia, 21001, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 30442714 BACKGROUND

• 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.

  PMID: 29536781 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Asthma; Lung Diseases, Obstructive; Lung Diseases

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

+1 301-398-0582

Study Officials

• William W Busse, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 3, 2014
• Study Start: February 19, 2015
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: March 15, 2019
• Results First Posted: May 16, 2018

Record last verified: 2019-02

Locations

BE (5); US (15); FR (5); NL (3); PL (9); DE (8); UA (6)