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

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: Semapimod

• Registration Number: NCT00740103
• Lead Sponsor: Ferring Pharmaceuticals

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.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-07
• Study Completion: 2004-09
• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Status Verified: 2012-08
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Semapimod	Semapimod 60 mg IV x 3 days q 6 - 8 weeks

Primary Outcome Measures

Name	Time	Method
Crohn's disease activity index (CDAI)	Every 6 - 8 weeks

Secondary Outcome Measures

Name	Time	Method
Safety measured by adverse events	Every 6 - 8 weeks

Trial Locations

Locations (26)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

Advanced Gastroenterology Associates; 🇺🇸 Suwanee, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Long Island Clinical Research Associates; 🇺🇸 Great Neck, New York, United States

Asher Kornbluth, MD; 🇺🇸 New York, New York, United States

Rochester General Hospital; 🇺🇸 Rochester, New York, United States

Gastroenterology Associates; 🇺🇸 Bristol, Tennessee, United States

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Academic Hospital Gasthuisberg; 🇧🇪 Leuven, Belgium

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