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Extension Study of Semapimod 60 mg IV x 3 Days (CD06)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Semapimod
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, TNF-alpha inhibitor, MAP Kinase inhibitor, CNI-1493

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The study was open to patients who had satisfactorily completed either study CNI-1493-CD-03 or CNI-1493-CD-05. Initial entry criteria were:

  1. Patients who satisfactorily completed either study CNI-1493-CD-03 or CD-05 were eligible for participation in this study. Satisfactory completion was defined as follows:

    1. The patient completed 5 treatment courses in the previous trial.
    2. The patient had responded to treatment, as defined by a decrease in CDAI of at least 70 points from original baseline (prior to treatment on study CD-02 or CD-04) at the last assessment for study CD-03 or CD-05, respectively. The decrease had to be attributable to semapimod treatment. Thus, patients whose response was attributable to other anti-Crohn's disease therapy are not to be included.
    3. The patient had no adverse event >grade 2 felt to be probably or definitely related to study medication.
    4. The patient did not meet any discontinuation criterion in previous trial.
  2. Patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, CNI-1493-CD-02 or CD-03, and CNI-1493-CD-04 or CD-05.
  3. Patients could not take any other investigational therapies during the course of this study.
  4. Men and women of childbearing potential had to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used.
  5. Patients had to be able to adhere to the study visit schedule and/or protocol requirements.

Exclusion Criteria:

Could not have met any of the exclusion criteria for the CD02, 03, 04 or 05 studies.

Sites / Locations

  • Northwestern University
  • Long Island Clinical Research Associates
  • Asher Kornbluth, MD
  • Benjamin Franklin University
  • Rambam Medical Center
  • Shaare Zedek Hospital
  • Tel Aviv Sourasky Medical Center
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Semapimod 60 mg IV q 6 - 10 weeks

Outcomes

Primary Outcome Measures

Crohn's Disease Activity Index (CDAI)

Secondary Outcome Measures

Safety

Full Information

First Posted
August 22, 2008
Last Updated
August 22, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00741910
Brief Title
Extension Study of Semapimod 60 mg IV x 3 Days
Acronym
CD06
Official Title
Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, TNF-alpha inhibitor, MAP Kinase inhibitor, CNI-1493

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Semapimod 60 mg IV q 6 - 10 weeks
Intervention Type
Drug
Intervention Name(s)
Semapimod
Other Intervention Name(s)
CNI-1493
Intervention Description
semapimod IV 60 mg x 3 days q 6 - 10 weeks
Primary Outcome Measure Information:
Title
Crohn's Disease Activity Index (CDAI)
Time Frame
Every 6 - 10 weeks
Secondary Outcome Measure Information:
Title
Safety
Time Frame
Every 6 - 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study was open to patients who had satisfactorily completed either study CNI-1493-CD-03 or CNI-1493-CD-05. Initial entry criteria were: Patients who satisfactorily completed either study CNI-1493-CD-03 or CD-05 were eligible for participation in this study. Satisfactory completion was defined as follows: The patient completed 5 treatment courses in the previous trial. The patient had responded to treatment, as defined by a decrease in CDAI of at least 70 points from original baseline (prior to treatment on study CD-02 or CD-04) at the last assessment for study CD-03 or CD-05, respectively. The decrease had to be attributable to semapimod treatment. Thus, patients whose response was attributable to other anti-Crohn's disease therapy are not to be included. The patient had no adverse event >grade 2 felt to be probably or definitely related to study medication. The patient did not meet any discontinuation criterion in previous trial. Patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, CNI-1493-CD-02 or CD-03, and CNI-1493-CD-04 or CD-05. Patients could not take any other investigational therapies during the course of this study. Men and women of childbearing potential had to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used. Patients had to be able to adhere to the study visit schedule and/or protocol requirements. Exclusion Criteria: Could not have met any of the exclusion criteria for the CD02, 03, 04 or 05 studies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daan Hommes, MD
Organizational Affiliation
Academic Medical Center, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Asher Kornbluth, MD
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Benjamin Franklin University
City
Berlin
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Shaare Zedek Hospital
City
Jerusalem
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

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Extension Study of Semapimod 60 mg IV x 3 Days

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