Crohn's DiseasePhase 2NCT01291810
Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients
A Phase 2 study testing TNF Kinoid and WFI in people with Crohn's Disease, run by Neovacs at 58 sites in 9 countries.
Trial summary
The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising. 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?
- TNF Kinoid and WFI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 58 sitesin 9 countries
- Study dates
- Feb 2011to May 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 65 years, inclusive.
- Have had a diagnosis of Crohn's disease for at least 6 months.
- Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
- Have developed secondary resistance to anti-TNFα therapy.
Who cannot join
- Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
- History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
- Treatment with immunosuppressive or immunomodulatory drugs
Trial locations and contacts
58 sites in 9 countries.
58 sites in 9 countries
Germany18 sites
Charité Campus Virchow-Klinikum
Berlin
Gastroenterologische Spezialpraxis
Berlin
Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte
Berlin
Klinikum Braunschweig
Braunschweig
Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH
Cologne
Klinik für Allg. Innere Medizin, Gastroenterologie und Diabetologie, Kliniken-Essen-Mitte/Evang. Huyssenstiftung
Essen
Universitätsklinik und Poliklinik für Innere Medizin I
Halle
Asklepios Westklinikum Hamburg
Hamburg
Hamburgisches Forschungsinstitut für CED
Hamburg
I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf
Hamburg
University Hospital Heidelberg
Heidelberg
Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne
Herne
Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie
Jena
Klinik für Innere Medizin I
Kiel
Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten
Leipzig
I. Med. Klinik und Poliklinik
Mainz
Universitätsklinikum Münster
Münster
Universitätsklinikum Ulm
Ulm
France12 sites
CHU Hôpital Nord
Amiens
Hôpital Haut-Lévêque
Bordeaux
CHU Caen
Caen
CHU Côte de Nacre
Caen
Hopital Beaujon (APHP)
Clichy
Hôpital de Bicêtre
Le Kremlin-Bicêtre
Hôpital A Huriez CHRU Lille
Lille
CHU Nancy Hôpital Brabois
Nancy
CHU de Nice Hôpital de l'Archet
Nice
Hôpital St Louis
Paris
CHU Rouen
Rouen
CHU Rangueil
Toulouse
Bulgaria7 sites
University Multiprofile Hospital St. Georgi
Plovdiv
Alexandrovska University Hospital
Sofia
Medical Institute- Ministry of Interior Clinic of Gastroenterology
Sofia
MMA Clinic of Gastroenterology
Sofia
UMHAT "St. Ivan Rilsky"
Sofia
UMHAT Queen Yoanna - ISUL
Sofia
Clinic of Gastroenterology/ University Hospital Varna
Varna
Romania5 sites
Colentina Clinical Hospital
Bucharest
Fundeni Clinical Institute
Bucharest
Mediclass Sananova SRL
Bucharest
Dr. Citu Outpatient Clinic
Timișoara
Polyclinic Private Practice Algomed SRL
Timișoara
Belgium4 sites
Imelda Clinic
Bonheiden
Cliniques Universitaires St Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent
Katholiek Unversiteit van Leuven
Leuven
Croatia4 sites
Clinical Hospital Centre Rijeka
Rijeka
General Hospital Zadar
Zadar
Clinical Hospital Centre Zagreb,
Zagreb
University Hospital Dubrava
Zagreb
Czechia3 sites
Faculty Hospital in Hradec Králové
Hradec Králové
Faculty Hospital Olomouc
Olomouc
IBD Clinical and Research Centre
Prague
Hungary3 sites
Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza
Budapest
Semmelweis Egyetem ÁOK
Budapest
DE OEC
Debrecen
Netherlands2 sites
Academic Medical Center (AMC)
Amsterdam
Free University Medical Centre in Amsterdam (VUMC)
Amsterdam
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFα-Kinoid in Adult Subjects With Crohn's Disease
The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising.
The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.
- Conditions
- Crohn's Disease
- Being tested
- TNF Kinoid, WFI
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF KinoidBiological
TNF Kinoid
WFIBiological
WFI
| Study group | Role | What they receive |
|---|---|---|
| TNF Kinoid | Experimental | Not described Receives: Biological: TNF Kinoid |
| Placebo | Placebo comparator | Not described Receives: Biological: WFI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission, defined as a CDAI score ≤ 150 points at week 8.
Measured: Week 8
Secondary outcomes (5)
Clinical responses, defined as a decrease of at least 70 points (CDAI-70) and at least 100 points (CDAI-100) in the CDAI score at week 8 vs baseline
Measured: week 8
Endoscopic response, defined as a reduction of at least 50% in the Crohn's Disease Endoscopic Index of Severity (CDEIS) score or in the Simple Endoscopic Score for Crohn's Disease (SES-CD) at week 12 vs baseline
Measured: week 12
Biological response as defined by a decrease or normalization of calprotectin levels in stools
Measured: Week 12
Safety assessments will be conducted throughout the study and will include physical examinations, vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory evaluations, and the recording of adverse events (AEs).
Measured: Week 28
Immunogenicity: o Anti-TNFα antibodies by Enzyme-Linked Immunosorbent Assay (ELISA) o Anti-TNFα neutralizing antibody activity o Anti-KLH antibodies by ELISA
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2012
- Study completionMay 2014
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovacs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291810
- Sponsor's protocol ID
- TNF-K-005
- Status last verified
- Sep 2014
- First submitted
- 17 Dec 2010
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFα-Kinoid in Adult Subjects With Crohn's Disease
- ClinicalTrials.gov ID
- NCT01291810
- Acronym / sponsor ID
- TNF-K-005
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- NeovacsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Feb 2011 (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 safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising.
The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNF Kinoid | Experimental | Biological: TNF Kinoid |
| Placebo | Placebo comparator | Biological: WFI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 to 65 years, inclusive.
- Have had a diagnosis of Crohn's disease for at least 6 months.
- Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
- Have developed secondary resistance to anti-TNFα therapy.
Key exclusion criteria (3 listed)
- Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
- History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
- Treatment with immunosuppressive or immunomodulatory drugs
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 |
|---|---|---|
| TNF KinoidTNF Kinoid | Biological | TNF Kinoid |
| WFIWFI | Biological | Placebo |
Primary outcome
Clinical remission, defined as a CDAI score ≤ 150 points at week 8.
Time frame: Week 8
5 secondary outcomes
Clinical responses, defined as a decrease of at least 70 points (CDAI-70) and at least 100 points (CDAI-100) in the CDAI score at week 8 vs baseline
Time frame: week 8
Endoscopic response, defined as a reduction of at least 50% in the Crohn's Disease Endoscopic Index of Severity (CDEIS) score or in the Simple Endoscopic Score for Crohn's Disease (SES-CD) at week 12 vs baseline
Time frame: week 12
Biological response as defined by a decrease or normalization of calprotectin levels in stools
Time frame: Week 12
Safety assessments will be conducted throughout the study and will include physical examinations, vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory evaluations, and the recording of adverse events (AEs).
Time frame: Week 28
Immunogenicity: o Anti-TNFα antibodies by Enzyme-Linked Immunosorbent Assay (ELISA) o Anti-TNFα neutralizing antibody activity o Anti-KLH antibodies by ELISA
Time frame: week 12
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 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
58 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNF Kinoid and WFI in people with Crohn's Disease, run by Neovacs at 58 sites in 9 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 4 inclusion and 3 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 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Germany, France, Bulgaria, Romania, Belgium and 4 more countries. 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?
Clinical remission, defined as a CDAI score ≤ 150 points at week 8. (time frame: Week 8). 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 Sep 2014.