Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00737932
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2008-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laquinimod Phase IIa Study in Active Crohn's Disease
Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Organization:
Study Overview
Official Title:
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: