A Phase 3 study to evaluate the Efficacy and Safety on Tralokinumab in Adults and Adolescents with oral corticosteroid dependent asthma.

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adolescents with Oral Corticosteroids dependent Asthma (TROPOS) - TROPOS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001391-54-BE

Enrollment

120

Registered

2015-01-27

Start date

2015-03-24

Completion date

Unknown

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Tralokinumab Product Code: CAT-354 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Tralokinumab CAS Number: 1044515-88-9 Current Sponsor code: CAT-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 12 to 75 years 2. Documented physician-diagnosed asthma. 3. Documented treatment with Inhaled Corticosteroid (ICS) at a total daily dose corresponding to =500µg fluticasone propionate dry powder formulation equivalents and a LABA. 4. Receiving Oral Corticosteroid (OCS) for the treatment of asthma. 5. Pre-BD FEV1 value =65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): 1. Difference vs. placebo in the proportion of subjects with final daily average oral corticosteroid (OCS) dose =5 mg at Week 40 post randomization. 2. Difference vs. placebo in the proportion of subjects with =50% reduction in average daily oral corticosteroid (OCS) dose at Week 40 post randomization.;Timepoint(s) of evaluation of this end point: Week 40	—

Primary

Measure	Time frame
Main Objective: To evaluate the effect of tralokinumab compared to placebo in reducing the prescribed, oral corticosteroid (OCS) maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroid (OCS) in addition to inhaled corticosteroid plus long-acting ß2-agonist (ICS/LABA).;Secondary Objective: 1. To evaluate the effect of tralokinumab compared to placebo on the proportion of subjects with the prescribed, oral corticosteroid (OCS) maintenance dose =5 mg in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroids (OCS) in addition to inhaled corticosteroid plus long-acting ß2-agonist (ICS/LABA). 2. To evaluate the effect of tralokinumab compared to placebo on the proportion of subjects with at least 50% reduction in their prescribed, oral corticosteroid (OCS) maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroids (OCS) in addition to inhaled corticosteroid plus long-acting ß2-agonist (ICS/LABA).;Primary end point(s): Percent change from baseline in the daily, average, oral corticosteroid (OCS) dose at week 40 post randomization while not losing asthma control.;Timepoint(s) of evaluation of this end point: Week 40	—

Measure

Time frame

Main Objective: To evaluate the effect of tralokinumab compared to placebo in reducing the prescribed, oral corticosteroid (OCS) maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroid (OCS) in addition to inhaled corticosteroid plus long-acting ß2-agonist (ICS/LABA).;Secondary Objective: 1. To evaluate the effect of tralokinumab compared to placebo on the proportion of subjects with the prescribed, oral corticosteroid (OCS) maintenance dose =5 mg in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroids (OCS) in addition to inhaled corticosteroid plus long-acting ß2-agonist (ICS/LABA). 2. To evaluate the effect of tralokinumab compared to placebo on the proportion of subjects with at least 50% reduction in their prescribed, oral corticosteroid (OCS) maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroids (OCS) in addition to inhaled corticosteroid plus long-acting ß2-agonist (ICS/LABA).;Primary end point(s): Percent change from baseline in the daily, average, oral corticosteroid (OCS) dose at week 40 post randomization while not losing asthma control.;Timepoint(s) of evaluation of this end point: Week 40

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Countries

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

Contacts

Public ContactEva Augurell

AstraZeneca AB

information.centre@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026