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Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease (CD05)

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 Semapimod, 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:

Inclusion Criteria

  1. Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:

    1. The patient met all eligibility criteria for participation in study CNI-1493-04 or was granted an exemption by the medical monitor for factors indicating ineligibility.
    2. The patient received at least 2 of the 3 planned doses of study medication.
    3. The patient had no adverse event >grade 2 felt to be possibly, probably or definitely related to study medication.
    4. The patient underwent all required evaluations, both for safety and efficacy, at baseline and day 29 and, for patients enrolling between days 43 and 57 of study CNI-1493-CD-04, at least one full later evaluation, ie the procedures required at day 43 and/or 57.

  2. At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:

    1. Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to baseline assessments, with the following exceptions:

      • those on methotrexate were to be on a stable dose for at least 4 weeks and must not be receiving more the 25mg/week
      • those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
      • those on corticosteroids were to have been on them for at least 2 weeks and on a stable for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone (or equivalent).
      • those on mesalazine were to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
      • those on antibiotics for CD were to have been on for at least 2 weeks and on a stable dose for those 2 weeks
    2. Patients who were not using other CD medications were to have stopped any previous use of these agents at least 4 weeks prior to baseline assessment for study CNI-1493-CD-05.
  3. Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.
  4. Men and women of childbearing potential were 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 were to be able to adhere to the study visit schedule and/or protocol requirements.

Exclusion Criteria:

Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.

Sites / Locations

  • University of California, San Francisco
  • Atlanta Gastroenterology Associates
  • Advanced Gastroenterology Associates
  • Northwestern University
  • Long Island Clinical Research Associates
  • Asher Kornbluth, MD
  • Rochester General Hospital
  • Gastroenterology Associates
  • Cliniques Universitaires Saint-Luc
  • Academic Hospital Gasthuisberg
  • Benjamin Franklin University
  • Medizinischen Hochschule-Hannover
  • Universitats Klinikum Heidelberg
  • University of Kiel
  • Gastroenterologische Fachpraxis
  • University of Munster
  • Stadtisches Krankenhaus Munchen-Bogenhausen
  • Rambam Medical Center
  • Hadassah Medical Center
  • Shaare Zedek Hospital
  • Tel Aviv Sourasky Medical Center
  • Chaim Sheba Medical Center
  • Academic Medical Center
  • Free University (Vrije Universiteit)
  • Academisch Ziekenhuis Maastricht
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Semapimod 60 mg IV x 3 days q 6 - 8 weeks

Outcomes

Primary Outcome Measures

Crohn's disease activity index (CDAI)

Secondary Outcome Measures

Safety measured by adverse events

Full Information

First Posted
August 21, 2008
Last Updated
August 22, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00740103
Brief Title
Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease
Acronym
CD05
Official Title
Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
September 2004 (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
CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).
Detailed Description
CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI). In addition, the safety of repeated courses was measured by recording adverse events over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Semapimod, 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
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Semapimod 60 mg IV x 3 days q 6 - 8 weeks
Intervention Type
Drug
Intervention Name(s)
Semapimod
Other Intervention Name(s)
CNI-1493
Intervention Description
60 mg IV x 3 days q 6 - 8 weeks
Primary Outcome Measure Information:
Title
Crohn's disease activity index (CDAI)
Time Frame
Every 6 - 8 weeks
Secondary Outcome Measure Information:
Title
Safety measured by adverse events
Time Frame
Every 6 - 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows: The patient met all eligibility criteria for participation in study CNI-1493-04 or was granted an exemption by the medical monitor for factors indicating ineligibility. The patient received at least 2 of the 3 planned doses of study medication. The patient had no adverse event >grade 2 felt to be possibly, probably or definitely related to study medication. The patient underwent all required evaluations, both for safety and efficacy, at baseline and day 29 and, for patients enrolling between days 43 and 57 of study CNI-1493-CD-04, at least one full later evaluation, ie the procedures required at day 43 and/or 57. At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04: Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to baseline assessments, with the following exceptions: those on methotrexate were to be on a stable dose for at least 4 weeks and must not be receiving more the 25mg/week those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks those on corticosteroids were to have been on them for at least 2 weeks and on a stable for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone (or equivalent). those on mesalazine were to have been on for at least 6 weeks and on a stable dose for at least 2 weeks those on antibiotics for CD were to have been on for at least 2 weeks and on a stable dose for those 2 weeks Patients who were not using other CD medications were to have stopped any previous use of these agents at least 4 weeks prior to baseline assessment for study CNI-1493-CD-05. Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04. Men and women of childbearing potential were 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 were to be able to adhere to the study visit schedule and/or protocol requirements. Exclusion Criteria: Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.
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
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Advanced Gastroenterology Associates
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
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
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Gastroenterology Associates
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Facility Name
Academic Hospital Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Benjamin Franklin University
City
Berlin
Country
Germany
Facility Name
Medizinischen Hochschule-Hannover
City
Hannover
Country
Germany
Facility Name
Universitats Klinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
University of Kiel
City
Kiel
Country
Germany
Facility Name
Gastroenterologische Fachpraxis
City
Minden
Country
Germany
Facility Name
University of Munster
City
Muenster
Country
Germany
Facility Name
Stadtisches Krankenhaus Munchen-Bogenhausen
City
Munchen
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
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
Chaim Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Free University (Vrije Universiteit)
City
Amsterdam
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease

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