BACKGROUND AND AIMS: @entity371 [ @entity371 ] mediates immune cell trafficking from the circulation to the inflamed colon and decreases gut epithelial cell survival. @entity371 expression is increased in @entity1 with @entity31 [ @entity31 ]. We report efficacy and safety results from a dose-ranging induction study of eldelumab, a fully human monoclonal antibody to @entity371 , in moderately to severely active @entity31 . METHODS: A total of 252 adults with @entity31 [Mayo score >=  6 and endoscopic subscore >=  2] were randomised 1:1:1 to placebo or eldelumab 15 or 25 mg/kg administered intravenously on Days 1 and 8 and every other week thereafter. The primary endpoint was clinical remission [Mayo score  <= 2; no individual subscale score > 1] at Week 11. Key secondary endpoints included Mayo score clinical response and @entity33 at Week 11. RESULTS: Neither eldelumab 15 or 25 mg/kg resulted in significant increases vs placebo in the proportion of @entity1 achieving Week 11 clinical remission. Remission and response rates were 17.6% and 47.1% with eldelumab 25mg/kg, 13.1% and 44.0% with eldelumab 15mg/kg, and 9.6% and 31.3% with placebo. Clinical remission and response rates were higher in anti- @entity5 @entity39 factor [TNF]-na  ve @entity1 treated with eldelumab compared with placebo. Eldelumab treatment was well tolerated and no immunogenicity was observed. CONCLUSIONS: The primary endpoint was not achieved with induction treatment with eldelumab 15 or 25 mg/kg in @entity1 with @entity31 . Trends towards clinical remission and response were observed in the overall population and were more pronounced in anti-TNF na  ve @entity1 . Eldelumab safety signals were consistent with those reported previously [ClinicalTrials.gov number, NCT01294410].

Eldelumab [Anti- @entity371 ] Induction Therapy for XXXX : A Randomised, Placebo-Controlled, Phase 2b Study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity39 :: ('MESH:D009336', 'Disease') :: ['necrosis'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumour'] @entity31 :: ('MESH:D003093', 'Disease') :: ['ulcerative colitis', 'UC'] @entity33 :: ('MESH:D052016', 'Disease') :: ['mucosal healing'] @entity371 :: ('3627', 'Gene') :: ['IP-10', 'Interferon-y-inducible protein-10']
@entity31 :: (MESH:D003093,Disease) :: ['Ulcerative Colitis']
