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)

Phase 3

Completed

Conditions: oral corticosteroid-dependent asthma
severe asthma
10006436

Registration Number: NL-OMON44438

Lead Sponsor: Site Management & Monitoring

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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. Morning pre-BD FEV1 value < 80% of their predicted normal value (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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome variable:<br /><br>Percent change from baseline in the daily, average, OCS dose at week 40 post<br /><br>randomization while not losing asthma control.<br /><br><br /><br>Primary outcome measure:<br /><br>Percent difference vs placebo at week 40 post randomisation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcome variables:<br /><br>- Difference vs. placebo in the proportion of subjects with final daily average<br /><br>OCS dose <=5 mg at Week 40 post randomization<br /><br><br /><br>- Difference vs. placebo in the proportion of subjects with >=50% reduction in<br /><br>average daily OCS dose at Week 40 post randomization</p><br>