Crohn's DiseasePhase 2CD04NCT00739986
Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo
A Phase 2 study testing Semapimod in people with Crohn's Disease, run by Ferring Pharmaceuticals at 28 sites in 5 countries.
Trial summary
Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's 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
- 152 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Oct 2002to Aug 2004
- 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
- Men and women at least 18 years of age.
- Baseline Crohn's Disease Activity Index (CDAI) 250-400.
- Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
- Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
- 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 screening, with the following exceptions:
- those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving more than 25 mg/wk
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- those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
- those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone or equivalent
- those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
- those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
- Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
- The screening laboratory tests were to meet the following criteria:
- Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)
- Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
- Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
Who cannot join
- Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
- History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
- Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
- Patients with any ostomy, extensive bowel resection (e.g., more than 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
- Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
- Patients with known severe fixed symptomatic stenosis of the small or large intestine.
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- Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
- Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
- Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
- Patients with previous diagnosis of, or known, malignancies.
- Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
- History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
- Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
- Women who were pregnant or breast-feeding.
- A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
- Patients who had received CNI-1493 in the past.
- More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United States10 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Gastroenterology Associates
Bristol, Tennessee, 37620
Northwestern University
Chicago, Illinois, 60611
Long Island Clinical Research Associates
Great Neck, New York, 11021
Gastroenterology Associates
Kingsport, Tennessee, 37660
Asher Kornbluth, MD
New York, New York, 10128
Rochester General Hospital
Rochester, New York, 14621
Institute of Healthcare Assessment
San Diego, California, 92120
University of California, San Francisco
San Francisco, California, 94115
Advanced Gastroenterology Associates
Suwanee, Georgia, 30024
Germany7 sites
Benjamin Franklin University
Berlin
Medizinischen Hochschule-Hannover
Hanover
Universitats Klinikum Heidelberg
Heidelberg
University of Kiel
Kiel
Gastroenterologische Fachpraxis
Minden
Stadtisches Krankenhaus Munchen-Bogenhausen
München
University of Munster
Münster
Israel5 sites
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Shaare Zedek Hospital
Jerusalem
Tel Aviv Sourasky Medical Center
Tel Aviv
Chaim Sheba Medical Center
Tel HaShomer
Netherlands4 sites
Academic Medical Center
Amsterdam
Free University (Vrije Universiteit)
Amsterdam
Academisch Ziekenhuis Maastricht
Maastricht
Erasmus Medical Center
Rotterdam
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels
Academic Hospital Gasthuisberg
Leuven
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment vs. Placebo
Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).
- Conditions
- Crohn's Disease
- Being tested
- Semapimod, Placebo
- Keywords
- Crohn's Disease, TNF-alpha, IL-6, MAP Kinase, CNI-1493
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemapimodDrug
semapimod 60 mg IV x 1 day, placebo x 2 days
SemapimodDrug
Semapimod 60 mg IV x 3 days
PlaceboDrug
placebo IV x 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Semapimod 60 mg IV x 1 day, placebo IV x 2 days Receives: Drug: Semapimod |
| 2 | Experimental | Semapimod 60 mg IV x 3 days Receives: Drug: Semapimod |
| 3 | Placebo comparator | Placebo comparator IV x 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Disease Activity Index (CDAI) score
Measured: Day 29
Secondary outcomes (4)
Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: Day 29
Crohn's disease endoscopic index of severity (CDEIS)
Measured: Day 29
Change in level of C-reactive protein (CRP)
Measured: Day 29
Safety (Adverse events)
Measured: Days 29 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startOct 2002
- Primary completionJun 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daan Hommes, MD, Principal investigator, Academic Medical Center, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739986
- Sponsor's protocol ID
- CNI-1493-CD04
- Acronym
- CD04
- Status last verified
- Aug 2012
- First submitted
- 20 Aug 2008
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. 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 1 or 3 Days' Treatment vs. Placebo
- ClinicalTrials.gov ID
- NCT00739986
- Acronym / sponsor ID
- CD04 / CNI-1493-CD04
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, TNF-alpha, IL-6, MAP Kinase, CNI-1493
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 22 Aug 2008 (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.
Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).
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 |
|---|---|---|
| 1 | Experimental | Drug: SemapimodSemapimod 60 mg IV x 1 day, placebo IV x 2 days |
| 2 | Experimental | Drug: SemapimodSemapimod 60 mg IV x 3 days |
| 3 | Placebo comparator | Drug: PlaceboPlacebo comparator IV x 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men and women at least 18 years of age.
- Baseline Crohn's Disease Activity Index (CDAI) 250-400.
- Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
- Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
- 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 screening, with the following exceptions:
Key exclusion criteria (17 listed)
- Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
- History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
- Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
- Patients with any ostomy, extensive bowel resection (e.g., more than 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
- Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
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 |
|---|---|---|
| Semapimodsemapimod 60 mg IV x 1 day, placebo x 2 days | Drug | 1 |
| SemapimodSemapimod 60 mg IV x 3 days | Drug | 2 |
| Placeboplacebo IV x 3 days | Drug | 3 |
Primary outcome
Crohn's Disease Activity Index (CDAI) score
Time frame: Day 29
4 secondary outcomes
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Day 29
Crohn's disease endoscopic index of severity (CDEIS)
Time frame: Day 29
Change in level of C-reactive protein (CRP)
Time frame: Day 29
Safety (Adverse events)
Time frame: Days 29 and 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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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, MD principal investigator
Academic Medical Center, Netherlands
28 sites in 5 countries: 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's Disease, run by Ferring Pharmaceuticals at 28 sites in 5 countries.
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 15 inclusion and 17 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: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Germany, Israel, Netherlands, Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Crohn's Disease Activity Index (CDAI) score (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2023.