Crohn's DiseasePhase 1/2NCT00808262
Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease
A Phase 1/2 study testing TNFa Kinoid in people with Crohn's Disease, run by Neovacs at 6 sites in 2 countries.
Trial summary
Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- TNFa Kinoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2008to Dec 2010
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have Active Crohn's Disease, as defined by a Crohn's Disease Activity Index (CDAI) score of >220 but ≤400, with active Crohn's disease of ileum and/or colon (Other areas may be involved if ileum and/or colon are also involved)based upon either endoscopic, histologic and/or radiographic evidence
- Patients with active disease despite treatment with 5-ASAs or sulfasalazine, corticosteroids (prednisone, budesonide, other), AZA or 6-MP or cyclosporine or MTX or Tacrolimus, ; OR intolerant of 5-ASAs or sulfasalazine; or intolerant of antibiotics; or intolerant of corticosteroids (prednisone, budesonide, other); or intolerant of AZA or 6-MP or cyclosporine or MTX or Tacrolimus
- Patients might have previously responded to any prior anti-TNF agents and then lost response OR might be intolerant of any prior anti-TNF agents
- Positive skin reaction to challenge with Candida antigens
- Written informed consent
Who cannot join
- Prior history of tuberculosis or positive chest X ray or positive purified protein derivative skin test or positive interferon gamma TB assay
- Signs or symptoms of clinically significant stricture of bowel.
- Total parenteral nutrition or elemental diet required for treatment of disease or support of short bowel syndrome
- Presence of an enteric stoma
- Imminent or urgent surgery required for infection, abscess, bleeding or any other cause relating to their Crohn's Disease or other condition
- History of malignancy. However, subjects with basal call carcinomas or less than 3 squamous cell carcinomas are allowed
Show all 20Show fewer
- History of asthma or serious allergic condition (including history of seafood allergy)
- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of study drug
- History of opportunistic infection excluding oral candidiasis on steroids
- Enteric infection as evidenced by positive stool C\&S, O\&P and C. difficile obtained during screening
- Any significant or decompensated cardiac, neurologic, liver, pulmonary or renal disease
- History of lymphoproliferative disorders
- Clinically significant abnormal hematology values, as determined by the investigator, for hematocrit, hemoglobin, white blood cell count or platelets
- Clinically significant abnormal blood chemistry values as determined by the investigator
- Current significant drug or alcohol abuse as determined by the investigator
- Positive for hepatitis C antibody or positive for hepatitis B surface antigen (HbsAg) or HIV infection
- Surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures)
- Participation in a clinical study (including previous participation in this study) within the previous 4 months
- Had a primary non-response to any prior anti-TNF agents as defined by the investigator OR received any prior anti-TNF agents within the past 8 weeks prior to study entry
- Pregnancy and lactation
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
South Africa4 sites
Farmovs Parexel
Bloemfontein
Durbanville Medi-Clinic
Cape Town, Cape, 7550
Parexel George
George
Parexel Port Elizabeth
Port Elizabeth, Eastern Cape
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois
Lausanne
Universitätsspital Zürich
Zurich
About this study
Official title: A Phase I/II, Open-label, Escalating Dose, "Optimal Two-stage", Study of TNFα-Kinoid (TNF- K) Immunization in Crohn's Disease Patients
Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- TNFa Kinoid
- Keywords
- anti-TNFa, immunization, kinoid, crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNFa KinoidBiological
TNFa kinoid at days 0, 7, 28
| Study group | Role | What they receive |
|---|---|---|
| TNFa Kinoid dose 1 | Experimental | Not described Receives: Biological: TNFa Kinoid |
| TNFa Kinoid dose 2 | Experimental | Not described Receives: Biological: TNFa Kinoid |
| TNFa Kinoid dose 3 | Experimental | Not described Receives: Biological: TNFa Kinoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: Whole study period
Secondary outcomes (1)
Antibody response
Measured: Day 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionDec 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovacs
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pierre Vandepapeliere, MD, PhD, Study director, Neovacs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808262
- Sponsor's protocol ID
- TNF-K-001
- Status last verified
- Jun 2011
- First submitted
- 12 Dec 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Escalating Dose, "Optimal Two-stage", Study of TNFα-Kinoid (TNF- K) Immunization in Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT00808262
- Acronym / sponsor ID
- TNF-K-001
- Conditions
- Crohn's Disease
- Keywords
- anti-TNFa, immunization, kinoid, crohn's disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NeovacsIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Dec 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.
Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TNFa Kinoid dose 1 | Experimental | Biological: TNFa Kinoid |
| TNFa Kinoid dose 2 | Experimental | Biological: TNFa Kinoid |
| TNFa Kinoid dose 3 | Experimental | Biological: TNFa Kinoid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have Active Crohn's Disease, as defined by a Crohn's Disease Activity Index (CDAI) score of >220 but ≤400, with active Crohn's disease of ileum and/or colon (Other areas may be involved if ileum and/or colon are also involved)based upon either endoscopic, histologic and/or radiographic evidence
- Patients with active disease despite treatment with 5-ASAs or sulfasalazine, corticosteroids (prednisone, budesonide, other), AZA or 6-MP or cyclosporine or MTX or Tacrolimus, ; OR intolerant of 5-ASAs or sulfasalazine; or intolerant of antibiotics; or intolerant of corticosteroids (prednisone, budesonide, other); or intolerant of AZA or 6-MP or cyclosporine or MTX or Tacrolimus
- Patients might have previously responded to any prior anti-TNF agents and then lost response OR might be intolerant of any prior anti-TNF agents
- Positive skin reaction to challenge with Candida antigens
- Written informed consent
Key exclusion criteria (20 listed)
- Prior history of tuberculosis or positive chest X ray or positive purified protein derivative skin test or positive interferon gamma TB assay
- Signs or symptoms of clinically significant stricture of bowel.
- Total parenteral nutrition or elemental diet required for treatment of disease or support of short bowel syndrome
- Presence of an enteric stoma
- Imminent or urgent surgery required for infection, abscess, bleeding or any other cause relating to their Crohn's Disease or other condition
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 |
|---|---|---|
| TNFa KinoidTNFa kinoid at days 0, 7, 28 | Biological | TNFa Kinoid dose 1, TNFa Kinoid dose 2, TNFa Kinoid dose 3 |
Primary outcome
Incidence and severity of adverse events
Time frame: Whole study period
1 secondary outcome
Antibody response
Time frame: Day 38
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 8 Jun 2011.
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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.
Pierre Vandepapeliere, MD, PhD study director
Neovacs
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNFa Kinoid in people with Crohn's Disease, run by Neovacs at 6 sites in 2 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 5 inclusion and 20 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Africa, Switzerland. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence and severity of adverse events (time frame: Whole study period). 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 8 Jun 2011.