Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F15%3A10292682" target="_blank" >RIV/00216208:11110/15:10292682 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1136/gutjnl-2014-308004" target="_blank" >http://dx.doi.org/10.1136/gutjnl-2014-308004</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/gutjnl-2014-308004" target="_blank" >10.1136/gutjnl-2014-308004</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study

Popis výsledku v původním jazyce

Objective Interleukin-13 (IL-13) has been implicated as a key driver of UC. This trial evaluates the efficacy and safety of tralokinumab, an IL-13-neutralising antibody, as add-on therapy in adults with moderate-to-severe UC despite standard treatments.Design Non-hospitalised adults with UC (total Mayo score >= 6) were randomised to receive tralokinumab 300 mg or placebo subcutaneously every 2 weeks for 12 weeks. The primary end point was the rate of clinical response at week 8. Secondary efficacy endpoints included clinical remission and mucosal healing rates at week 8 and changes in total Mayo score, total modified Riley score, partial Mayo score and disease activity markers. Results Clinical response rate was 38% (21/56) for tralokinumab vs 33% (18/55) for placebo (p=0.406). Clinical remission rate was 18% (10/56) vs 6% (3/55) (p=0.033) and mucosal healing rate was 32% (18/56) vs 20% (11/55) (p=0.104) for tralokinumab vs placebo. Changes to week 8 in total Mayo score and total mod

Název v anglickém jazyce

Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study

Popis výsledku anglicky

Objective Interleukin-13 (IL-13) has been implicated as a key driver of UC. This trial evaluates the efficacy and safety of tralokinumab, an IL-13-neutralising antibody, as add-on therapy in adults with moderate-to-severe UC despite standard treatments.Design Non-hospitalised adults with UC (total Mayo score >= 6) were randomised to receive tralokinumab 300 mg or placebo subcutaneously every 2 weeks for 12 weeks. The primary end point was the rate of clinical response at week 8. Secondary efficacy endpoints included clinical remission and mucosal healing rates at week 8 and changes in total Mayo score, total modified Riley score, partial Mayo score and disease activity markers. Results Clinical response rate was 38% (21/56) for tralokinumab vs 33% (18/55) for placebo (p=0.406). Clinical remission rate was 18% (10/56) vs 6% (3/55) (p=0.033) and mucosal healing rate was 32% (18/56) vs 20% (11/55) (p=0.104) for tralokinumab vs placebo. Changes to week 8 in total Mayo score and total mod

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FE - Ostatní obory vnitřního lékařství

OECD FORD obor

—

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2015

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Gut

ISSN

0017-5749

e-ISSN

—

Svazek periodika

64

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

7

Strana od-do

243-249

Kód UT WoS článku

000348449800011

EID výsledku v databázi Scopus

2-s2.0-84920942417