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

Asthma Clinical Trial

— TROPOS  

Official title:

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adolescents With Oral Corticosteroid Dependent Asthma (TROPOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281357
• Other study ID #: D2210C00013
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2015
• Est. completion date: September 7, 2017

Study information

• Verified date: February 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 7, 2017
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Tralokinumab
Tralokinumab dose

Other:
• Placebo
Placebo dose

Locations

Country	Name	City	State
Belgium	Research Site	Brussels (Anderlecht)
Belgium	Research Site	Gent
Belgium	Research Site	Hasselt
Belgium	Research Site	Leuven
Belgium	Research Site	Woluwé-St-Lambert
France	Research Site	GRENOBLE Cedex 9
France	Research Site	Lille Cedex
France	Research Site	Lyon Cedex 04
France	Research Site	Nantes Cedex 1
France	Research Site	Pessac
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Frankfurt
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Mainz
Germany	Research Site	München
Germany	Research Site	München-Pasing
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Groningen
Netherlands	Research Site	Leeuwarden
Poland	Research Site	Bystra Slaska
Poland	Research Site	Kraków
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Lubin
Poland	Research Site	Ostrowiec Swietokrzyski
Poland	Research Site	Rzeszów
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Ukraine	Research Site	Dnipro
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Vinnytsia
United States	Research Site	Anderson	South Carolina
United States	Research Site	Boerne	Texas
United States	Research Site	Bronx	New York
United States	Research Site	Clearwater	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Durham	North Carolina
United States	Research Site	Monroeville	Pennsylvania
United States	Research Site	New Haven	Connecticut
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Netherlands,  Poland,  Ukraine, 

References & Publications (1)

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). pii: 1800948. doi: 10.1183/13993003.00948-2018. Print 2019 Feb. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Number of Patients With Final Daily Average OCS Dose =5 mg at Week 40.	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.; The number of patients with a final daily average OCS dose =5.0 mg is presented. For patients prescribed a fixed daily dose, then the average OCS dose was defined as the prescribed dose. For patients on a regimen where a different amount of OCS was to be taken each day, then the average OCS dose was defined as the average amount prescribed to be taken each day.	At Week 40
Secondary	The Number of Patients With =50% Reduction in Final Average Daily OCS Dose at Week 40.	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.; The number of patients with =50% reduction 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%. If this resulted in a value of -50% or less (more negative), that patient was classified as having at least a 50% reduction in final daily average OCS dose.	At Week 40
Secondary	Annual Asthma Exacerbation Rate (AAER) up to Week 40.	AAER up to Week 40 in the tralokinumab group was compared to that seen in the placebo group. The response variable was the number of exacerbations the patient experienced up to Week 40, with the logarithm of the time at risk in years of experiencing an exacerbation included as offset in the model.; AAER = number of exacerbations*365.25/(follow-up date - date of randomisation + 1).; Asthma exacerbation was defined as a worsening of asthma that led to any of the following: Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.; An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for <24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids.; An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for =24 hours) due to asthma.	Baseline (Week 0) up to Week 40

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