Crohn's DiseasePhase 2CD06NCT00741910
Extension Study of Semapimod 60 mg IV x 3 Days
A Phase 2 study testing Semapimod in people with Crohn's Disease, run by Ferring Pharmaceuticals at 8 sites in 4 countries.
Trial summary
Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events. 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?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jul 2003to Jun 2006
- 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
- The study was open to patients who had satisfactorily completed either study CNI-1493-CD-03 or CNI-1493-CD-05. Initial entry criteria were:
- Patients who satisfactorily completed either study CNI-1493-CD-03 or CD-05 were eligible for participation in this study. Satisfactory completion was defined as follows:
- The patient completed 5 treatment courses in the previous trial.
- The patient had responded to treatment, as defined by a decrease in CDAI of at least 70 points from original baseline (prior to treatment on study CD-02 or CD-04) at the last assessment for study CD-03 or CD-05, respectively. The decrease had to be attributable to semapimod treatment. Thus, patients whose response was attributable to other anti-Crohn's disease therapy are not to be included.
- The patient had no adverse event >grade 2 felt to be probably or definitely related to study medication.
- The patient did not meet any discontinuation criterion in previous trial.
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- Patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, CNI-1493-CD-02 or CD-03, and CNI-1493-CD-04 or CD-05.
- Patients could not take any other investigational therapies during the course of this study.
- Men and women of childbearing potential had 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 had to be able to adhere to the study visit schedule and/or protocol requirements.
Who cannot join
- Could not have met any of the exclusion criteria for the CD02, 03, 04 or 05 studies.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Long Island Clinical Research Associates
Great Neck, New York, 11021
Asher Kornbluth, MD
New York, New York, 10128
Israel3 sites
Rambam Medical Center
Haifa
Shaare Zedek Hospital
Jerusalem
Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.
- Conditions
- Crohn's Disease
- Being tested
- Semapimod
- Keywords
- 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
semapimod IV 60 mg x 3 days q 6 - 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Semapimod 60 mg IV q 6 - 10 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 - 10 weeks
Secondary outcomes (1)
Safety
Measured: Every 6 - 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startJul 2003
- Primary completionJun 2006
- Study completionJun 2006
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
- 15 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
- NCT00741910
- Sponsor's protocol ID
- CNI-1493-CD06
- Acronym
- CD06
- Status last verified
- Aug 2012
- First submitted
- 22 Aug 2008
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT00741910
- Acronym / sponsor ID
- CD06 / CNI-1493-CD06
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, TNF-alpha inhibitor, MAP Kinase inhibitor, CNI-1493
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 26 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.
Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.
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 q 6 - 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The study was open to patients who had satisfactorily completed either study CNI-1493-CD-03 or CNI-1493-CD-05. Initial entry criteria were:
- Patients who satisfactorily completed either study CNI-1493-CD-03 or CD-05 were eligible for participation in this study. Satisfactory completion was defined as follows:
- Patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, CNI-1493-CD-02 or CD-03, and CNI-1493-CD-04 or CD-05.
- Patients could not take any other investigational therapies during the course of this study.
- Men and women of childbearing potential had 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.
Key exclusion criteria (1 listed)
- Could not have met any of the exclusion criteria for the CD02, 03, 04 or 05 studies.
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-1493semapimod IV 60 mg x 3 days q 6 - 10 weeks | Drug | 1 |
Primary outcome
Crohn's Disease Activity Index (CDAI)
Time frame: Every 6 - 10 weeks
1 secondary outcome
Safety
Time frame: Every 6 - 10 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 18 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
8 sites in 4 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 8 sites in 4 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 10 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 18 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 8 sites in United States, Israel, Germany, Netherlands. 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 - 10 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 18 Nov 2023.