Extension Study of Semapimod 60 mg IV x 3 Days

NCT00741910 | Completed Phase 2

• 1 other identifier: CNI-1493-CD06
• Study Type: interventional
• Target: 15
• Locations: 4 countries
• Sites: 8

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; TNF-alpha inhibitor; MAP Kinase inhibitor; CNI-1493

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease Activity Index (CDAI)

  Every 6 - 10 weeks

Secondary Outcomes (1)

• Safety

  Every 6 - 10 weeks

Study Arms (1)

1

EXPERIMENTAL

Semapimod 60 mg IV q 6 - 10 weeks

Drug: Semapimod

Interventions

Semapimod DRUG

semapimod IV 60 mg x 3 days q 6 - 10 weeks

Also known as: CNI-1493

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (8)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

Asher Kornbluth, MD

New York, New York, 10128, United States

Location

Benjamin Franklin University

Berlin, Germany

Location

Rambam Medical Center

Haifa, Israel

Location

Shaare Zedek Hospital

Jerusalem, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

semapimod

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Daan Hommes, MD

  Academic Medical Center, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 26, 2008
• Study Start: July 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: November 18, 2023

Record last verified: 2012-08

Locations

DE (1); NL (1); US (3); IL (3)