Crohn's DiseasePhase 2CD05NCT00740103
Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease
A Phase 2 study testing Semapimod in people with Crohn's Disease, run by Ferring Pharmaceuticals at 26 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Semapimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 26 sitesin 5 countries
- Study dates
- Dec 2002to Sep 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
Who cannot join
- Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
United States8 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
Asher Kornbluth, MD
New York, New York, 10128
Rochester General Hospital
Rochester, New York, 14621
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: Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo
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).
Read the detailed description
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). In addition, the safety of repeated courses was measured by recording adverse events over time.
- Conditions
- Crohn's Disease
- Being tested
- Semapimod
- Keywords
- Semapimod, Crohn's Disease, TNF-alpha inhibitor, MAP Kinase inhibitor, 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
Also called CNI-1493
60 mg IV x 3 days q 6 - 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Semapimod 60 mg IV x 3 days q 6 - 8 weeks Receives: Drug: Semapimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's disease activity index (CDAI)
Measured: Every 6 - 8 weeks
Secondary outcomes (1)
Safety measured by adverse events
Measured: Every 6 - 8 weeks
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 startDec 2002
- Primary completionJul 2004
- Study completionSep 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 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
- NCT00740103
- Sponsor's protocol ID
- CNI-1493-CD05
- Acronym
- CD05
- Status last verified
- Aug 2012
- First submitted
- 21 Aug 2008
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo
- ClinicalTrials.gov ID
- NCT00740103
- Acronym / sponsor ID
- CD05 / CNI-1493-CD05
- Conditions
- Crohn's Disease
- Keywords
- Semapimod, Crohn's Disease, TNF-alpha inhibitor, MAP Kinase inhibitor, CNI-1493
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jul 2004 (actual)
- Study completion
- Sep 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.
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).
Detailed description
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). In addition, the safety of repeated courses was measured by recording adverse events over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SemapimodSemapimod 60 mg IV x 3 days q 6 - 8 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:
- 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 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.
- Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
Key exclusion criteria (1 listed)
- Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.
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-149360 mg IV x 3 days q 6 - 8 weeks | Drug | 1 |
Primary outcome
Crohn's disease activity index (CDAI)
Time frame: Every 6 - 8 weeks
1 secondary outcome
Safety measured by adverse events
Time frame: Every 6 - 8 weeks
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 28 Mar 2025.
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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
26 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 26 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 16 inclusion and 1 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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. 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) (time frame: Every 6 - 8 weeks). 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 28 Mar 2025.