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



Status:Completed
Conditions:Asthma, Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 75
Updated:3/17/2019
Start Date:February 19, 2015
End Date:September 7, 2017

Use our guide to learn which trials are right for you!

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)

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.

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.

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.
We found this trial at
16
sites
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
2008
mi
from 91732
Anderson, SC
Click here to add this to my saved trials
1166
mi
from 91732
Boerne, TX
Click here to add this to my saved trials
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
?
mi
from 91732
Brussels (Anderlecht),
Click here to add this to my saved trials
2117
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
2202
mi
from 91732
Durham, NC
Click here to add this to my saved trials
2130
mi
from 91732
Monroeville, PA
Click here to add this to my saved trials
2486
mi
from 91732
New Haven, CT
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
2267
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
1573
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
2042
mi
from 91732
Spartanburg, SC
Click here to add this to my saved trials
1315
mi
from 91732
Tyler, TX
Click here to add this to my saved trials