A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

Summary

The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.

Timeline

Start

2006-03

Primary completion

2008-08

Completion

2009-06

Outcome

Missed primary endpoint

paper Response rates at week 8 were 49% in the placebo group, 52% in the group given CCX282-B 250 mg once daily (odds ratio [OR] = 1.12; p = .667 vs placebo) PMID 23527300 ↗

paper 46% showed sustained clinical responses, compared to 42% on placebo (OR = 1.14; p = .629). PMID 23527300 ↗

Publications

• Keshav S, Vanasek T, Niv Y, Petryka R, Howaldt S, Bafutto M, Racz I, Hetzel D, Nielsen OH, Vermeire S, Reinisch W, Karlen P, Schreiber S, Schall TJ, Bekker P; Prospective Randomized Oral-Therapy Evaluation in Crohn's Disease Trial-1 PROTECT-1 Study Group. A randomized controlled trial of the efficacy and safety of CCX282-B, an orally-administered blocker of chemokine receptor CCR9, for patients with Crohn's disease. PLoS One. 2013;8(3):e60094. doi: 10.1371/journal.pone.0060094. Epub 2013 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	vercirnon	Small molecule	250 mg	Oral
Subject	vercirnon	Small molecule	500 mg	Oral

Indications