NCT00038766

Brief Summary

The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohn's Disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

June 5, 2002

Last Update Submit

August 22, 2012

Conditions

Crohn Disease

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Change in CDAI

    Day 29

Secondary Outcomes (1)

  • Change in IBDQ

    Day 29

Study Arms (3)

Semapimod 60 mg

EXPERIMENTAL

Semapimod 60 mg IV x 5 days

Drug: semapimod

Semapimod IV 30 mg

EXPERIMENTAL

Semapimod IV 30 mg x 5 days

Drug: semapimod

Placebo

PLACEBO COMPARATOR

Placebo IV x 3 or 5 days

Drug: placebo

Interventions

semapimodDRUG

semapipmod 60 mg IV x 5 days

Also known as: CNI-1493
Semapimod 60 mg
placeboDRUG

placebo IV

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Baseline Crohn's Disease Activity Index (CDAI) 250-400, inclusive
  • Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy
  • Patients receiving medications for CD must be on stable doses entering the study
  • Any CD medication which has been discontinued must have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which must have been discontinued at least 8 weeks prior to screening

You may not qualify if:

  • Patients with any ostomy or extensive bowel resection
  • Current evidence of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery
  • Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin
  • Treatment with any other experimental therapeutics within the last 4 weeks before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Institute of Healthcare Assessment

San Diego, California, 92120, United States

Location

University of Florida

Gainesville, Florida, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

Washington University School of Medicine

St Louis, Missouri, United States

Location

Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

Mount Sinai School of Medicine

New York, New York, United States

Location

Charlotte Gastroenterology and Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Location

Regional Gastroenterology Associates of Lancaster, Ltd.

Lancaster, Pennsylvania, 17604, United States

Location

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

  • Hommes D, van den Blink B, Plasse T, Bartelsman J, Xu C, Macpherson B, Tytgat G, Peppelenbosch M, Van Deventer S. Inhibition of stress-activated MAP kinases induces clinical improvement in moderate to severe Crohn's disease. Gastroenterology. 2002 Jan;122(1):7-14. doi: 10.1053/gast.2002.30770.

    PMID: 11781274BACKGROUND

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

semapimod

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Daan Hommes, M

    Academic Medical Center, Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2002

First Posted

June 7, 2002

Study Start

June 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

US(13)