CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
BL-7040drug
Likely dose
BL-7040 12 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01506362
NCT01506362Phase 2Completed
CompareCT.gov

An Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis

BioLineRx, Ltd.·interventional·Posted Jan 10, 2012·Updated Jul 15, 2014

In Brief

A Phase 2 clinical trial evaluating BL-7040 for Ulcerative Colitis. Completed, enrolled 22 participants across 5 sites.

Detailed Summary

The objective of the proposed study is to determine whether BL-7040 demonstrates clinical efficacy in patients with inflammatory bowel disease (IBD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesIsrael
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2012
Enrollment StartMar 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.5 years ago

Interventions

BL-7040drug

BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems. Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up. BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days.