The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis

Summary

The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.

Timeline

Start

2017-06-21

Primary completion

2019-08-30

Completion

2019-08-30

Outcome

Met primary endpoint

paper A greater proportion of patients were in clinical remission at week 6 in the cobitolimod 2 × 250 mg group than in the placebo group PMID 33031757 ↗

paper nine [21%] of 42 patients vs three [7%] of 44; odds ratio [OR] 3·8 [80% CI 1·5-9·5]; one-sided p=0·025). PMID 33031757 ↗

Publications

• Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hebuterne X, Arnesson K, Knittel T, Kowalski J, Neurath MF, Sandborn WJ, Reinisch W; CONDUCT study group. Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial. Lancet Gastroenterol Hepatol. 2020 Dec;5(12):1063-1075. doi: 10.1016/S2468-1253(20)30301-0. Epub 2020 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cobitolimod	Oligonucleotide (other)	31 mg	Rectal
Subject	Cobitolimod	Oligonucleotide (other)	125 mg	Rectal
Subject	Cobitolimod	Oligonucleotide (other)	250 mg	Rectal

Indications