Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-31 @ 2:13 AM
Study NCT ID:
NCT03178669
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2017-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
Sponsor:
InDex Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
Status:
COMPLETED
Status Verified Date:
2021-01
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:
CONDUCT
Brief 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.
Detailed Description:
This was a Phase IIb study in patients with moderate to severe left-sided ulcerative colitis. Patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. To ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. Blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. Primary endpoint was evaluated at week 6.
Duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).
Duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-004217-26 | EUDRACT_NUMBER | None | View |