WHO ICTRP trial

A Phase 3 study to evaluate the Efficacy and Safety on Tralokinumab in Adults…

EUCTR2014-001391-54-BE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2014-001391-54-BE
Public title A Phase 3 study to evaluate the Efficacy and Safety on Tralokinumab in Adults and Adolescents with oral corticosteroid dependent asthma.
Scientific title 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
Primary sponsor AstraZeneca AB
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries France;United States;Poland;Belgium;Netherlands;Germany
Conditions Asthma MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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-354 Other descriptive name: Tralokinumab…
Registration date Jan 27, 2015
Target size 120
Secondary IDs D2210C00013;NCT02281357;2014-001391-54-DE
Registry page clinicaltrialsregister.eu

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