Extension Study of Semapimod 60 mg IV x 3 Days

Phase 2

Completed

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

• Registration Number: NCT00741910
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-26
• Status Verified: 2012-08
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Semapimod	Semapimod 60 mg IV q 6 - 10 weeks

Primary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index (CDAI)	Every 6 - 10 weeks

Secondary Outcome Measures

Name	Time	Method
Safety	Every 6 - 10 weeks

Trial Locations

Locations (8)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Northwestern University; 🇺🇸 Chicago, Illinois, United States

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

Benjamin Franklin University; 🇩🇪 Berlin, Germany

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

Shaare Zedek Hospital; 🇮🇱 Jerusalem, Israel