Crohn DiseasePhase 2CD02NCT00038766
CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
A Phase 2 study testing semapimod in people with Crohn Disease, run by Ferring Pharmaceuticals at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- semapimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 13 sitesUnited States
- Study dates
- Jun 2002to Jun 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207
Northwestern University
Chicago, Illinois
University of Chicago
Chicago, Illinois
University of Florida
Gainesville, Florida
Long Island Clinical Research Associates
Great Neck, New York, 11021
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604
Mount Sinai School of Medicine
New York, New York
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma
Wake Research Associates
Raleigh, North Carolina, 27612
Institute of Healthcare Assessment
San Diego, California, 92120
Washington University School of Medicine
St Louis, Missouri
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
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.
Read the detailed description
Crohn's disease (CD) is a chronic inflammatory disease involving the upper and lower gastrointestinal tract and characterized by abdominal pain, weight loss, gastrointestinal bleeding and formation of fistulas between loops of bowel and from the bowel to the skin or other organs. Current therapy for active Crohn's disease consists of symptomatic treatment, nutritional therapy, salicylates and immunosuppressants or surgical management.
Tumor necrosis factor a (TNF-a) plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in CD (van Deventer, 1997). Increased TNF-a is present in gut mucosa as well as in stool of patients with active CD (Braegger et al, 1992). CNI-1493 is a synthetic guanylhydrazone compound that is an inhibitor of TNF-a synthesis. A monoclonal antibody to TNF, infliximab, is now approved for treatment of CD, but not all patients respond and many who do respond eventually become refractory to this treatment as well.
CNI-1493 is a synthetic compound which blocks the production of several inflammatory cytokines, including TNF. Because it blocks production of multiple inflammatory mediators, it may be more active than products targeted to a specific cytokine. In addition, as it is not a biologic, it should not cause hypersensitivity reactions or induce formation of antibodies.
The purpose of this trial is to determine if CNI-1493 is safe and effective in treating patients with moderate to severe Crohn's Disease in a placebo controlled setting.
- Conditions
- Crohn Disease
- Being tested
- semapimod, placebo
- Keywords
- Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semapimodDrug
Also called CNI-1493
semapipmod 60 mg IV x 5 days
semapimodDrug
Also called CNI-1493
IV 30 mg x 5 days
placeboDrug
placebo IV
| Study group | Role | What they receive |
|---|---|---|
| Semapimod 60 mg | Experimental | Semapimod 60 mg IV x 5 days Receives: Drug: semapimod |
| Semapimod IV 30 mg | Experimental | Semapimod IV 30 mg x 5 days Receives: Drug: semapimod |
| Placebo | Placebo comparator | Placebo IV x 3 or 5 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CDAI
Measured: Day 29
Secondary outcomes (1)
Change in IBDQ
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2002 (estimated)
- Study startJun 2002
- Primary completionJun 2003
- Study completionJun 2003
Why it stopped: Unable to enroll into study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daan Hommes, M, Principal investigator, Academic Medical Center, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038766
- Sponsor's protocol ID
- CNI-1493 CD-02
- Acronym
- CD02
- Status last verified
- Aug 2012
- First submitted
- 5 Jun 2002
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11781274
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT00038766
- Acronym / sponsor ID
- CD02 / CNI-1493 CD-02
- Conditions
- Crohn Disease
- Keywords
- Inflammatory Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll into study.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 7 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Crohn's disease (CD) is a chronic inflammatory disease involving the upper and lower gastrointestinal tract and characterized by abdominal pain, weight loss, gastrointestinal bleeding and formation of fistulas between loops of bowel and from the bowel to the skin or other organs. Current therapy for active Crohn's disease consists of symptomatic treatment, nutritional therapy, salicylates and immunosuppressants or surgical management.
Tumor necrosis factor a (TNF-a) plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in CD (van Deventer, 1997). Increased TNF-a is present in gut mucosa as well as in stool of patients with active CD (Braegger et al, 1992). CNI-1493 is a synthetic guanylhydrazone compound that is an inhibitor of TNF-a synthesis. A monoclonal antibody to TNF, infliximab, is now approved for treatment of CD, but not all patients respond and many who do respond eventually become refractory to this treatment as well.
CNI-1493 is a synthetic compound which blocks the production of several inflammatory cytokines, including TNF. Because it blocks production of multiple inflammatory mediators, it may be more active than products targeted to a specific cytokine. In addition, as it is not a biologic, it should not cause hypersensitivity reactions or induce formation of antibodies.
The purpose of this trial is to determine if CNI-1493 is safe and effective in treating patients with moderate to severe Crohn's Disease in a placebo controlled setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semapimod 60 mg | Experimental | Drug: semapimodSemapimod 60 mg IV x 5 days |
| Semapimod IV 30 mg | Experimental | Drug: semapimodSemapimod IV 30 mg x 5 days |
| Placebo | Placebo comparator | Drug: placeboPlacebo IV x 3 or 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semapimodAlso: CNI-1493semapipmod 60 mg IV x 5 days | Drug | Semapimod 60 mg |
| semapimodAlso: CNI-1493IV 30 mg x 5 days | Drug | Semapimod IV 30 mg |
| placeboplacebo IV | Drug | Placebo |
Primary outcome
Change in CDAI
Time frame: Day 29
1 secondary outcome
Change in IBDQ
Time frame: Day 29
Results and safety
The study was stopped early (reason given: Unable to enroll into study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Background: PubMed 11781274Hommes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daan Hommes, M principal investigator
Academic Medical Center, Netherlands
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing semapimod in people with Crohn Disease, run by Ferring Pharmaceuticals at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to enroll into study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CDAI (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00038766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.