CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 689 enrolled
Drug / intervention
Tralokinumab 300 mg, Q2W +3 morebiological
Likely dose
Tralokinumab 300 mg, Q2Wfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01402986
NCT01402986Phase 2Completed
CompareCT.gov

A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma

MedImmune LLC·interventional·Posted Jul 27, 2011·Updated Apr 4, 2017

In Brief

A Phase 2 clinical trial evaluating Placebo Q2W, Tralokinumab 300 mg, Q2W, and 2 other interventions for Asthma. Completed, enrolled 689 participants across 89 sites in 15 countries.

Detailed Summary

The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Canada, Chile, Czechia, France, Germany, Japan, Mexico, Philippines, Poland, Russia, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2011
Enrollment StartAug 1, 2011
Primary CompletionJun 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.9 years ago

Interventions

Placebo Q2Wother

Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

Tralokinumab 300 mg, Q2Wbiological

Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.

Placebo, Q2/4Wother

Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.

Tralokinumab 300 mg, Q2/4Wbiological

Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.