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

NCT00740103 | Completed Phase 2

• 1 other identifier: CNI-1493-CD05
• Study Type: interventional
• Target: 119
• Locations: 5 countries
• Sites: 26

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).

Conditions

Crohn's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Crohn's disease activity index (CDAI)

  Every 6 - 8 weeks

Secondary Outcomes (1)

• Safety measured by adverse events

  Every 6 - 8 weeks

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Semapimod

Interventions

Semapimod DRUG

60 mg IV x 3 days q 6 - 8 weeks

Also known as: CNI-1493

1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (26)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Advanced Gastroenterology Associates

Suwanee, Georgia, 30024, United States

Location

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

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Gastroenterology Associates

Bristol, Tennessee, 37620, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Academic Hospital Gasthuisberg

Leuven, Belgium

Location

Benjamin Franklin University

Berlin, Germany

Location

Medizinischen Hochschule-Hannover

Hanover, Germany

Location

Universitats Klinikum Heidelberg

Heidelberg, Germany

Location

University of Kiel

Kiel, Germany

Location

Gastroenterologische Fachpraxis

Minden, Germany

Location

Stadtisches Krankenhaus Munchen-Bogenhausen

München, Germany

Location

University of Munster

Münster, Germany

Location

Rambam Medical Center

Haifa, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Shaare Zedek Hospital

Jerusalem, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Free University (Vrije Universiteit)

Amsterdam, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

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 21, 2008
• First Posted: August 22, 2008
• Study Start: December 1, 2002
• Primary Completion: July 1, 2004
• Study Completion: September 1, 2004
• Last Updated: March 28, 2025

Record last verified: 2012-08

Locations

US (8); IL (5); DE (7); BE (2); NL (4)