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

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).

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.

Eligibility Criteria:
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.