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Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TNF Kinoid
WFI
Sponsored by
Neovacs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female aged 18 to 65 years, inclusive.
  2. Have had a diagnosis of Crohn's disease for at least 6 months.
  3. 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.
  4. Have developed secondary resistance to anti-TNFα therapy.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Treatment with immunosuppressive or immunomodulatory drugs

Sites / Locations

  • Imelda Clinic
  • Cliniques Universitaires St Luc
  • Universitair Ziekenhuis Gent
  • Katholiek Unversiteit van Leuven
  • University Multiprofile Hospital St. Georgi
  • Alexandrovska University Hospital
  • Medical Institute- Ministry of Interior Clinic of Gastroenterology
  • MMA Clinic of Gastroenterology
  • UMHAT "St. Ivan Rilsky"
  • UMHAT Queen Yoanna - ISUL
  • Clinic of Gastroenterology/ University Hospital Varna
  • Clinical Hospital Centre Rijeka
  • General Hospital Zadar
  • Clinical Hospital Centre Zagreb,
  • University Hospital Dubrava
  • Faculty Hospital in Hradec Králové
  • Faculty Hospital Olomouc
  • IBD Clinical and Research Centre
  • CHU Hôpital Nord
  • Hôpital Haut-Lévêque
  • CHU Caen
  • CHU Côte de Nacre
  • Hopital Beaujon (APHP)
  • Hôpital de Bicêtre
  • Hôpital A Huriez CHRU Lille
  • CHU Nancy Hôpital Brabois
  • CHU de Nice Hôpital de l'Archet
  • Hôpital St Louis
  • CHU Rouen
  • CHU Rangueil
  • Charité Campus Virchow-Klinikum
  • Gastroenterologische Spezialpraxis
  • Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte
  • Klinikum Braunschweig
  • Klinik für Allg. Innere Medizin, Gastroenterologie und Diabetologie, Kliniken-Essen-Mitte/Evang. Huyssenstiftung
  • Universitätsklinik und Poliklinik für Innere Medizin I
  • Asklepios Westklinikum Hamburg
  • Hamburgisches Forschungsinstitut für CED
  • I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf
  • University Hospital Heidelberg
  • Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne
  • Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie
  • Klinik für Innere Medizin I
  • Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH
  • Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten
  • I. Med. Klinik und Poliklinik
  • Universitätsklinikum Münster
  • Universitätsklinikum Ulm
  • Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza
  • Semmelweis Egyetem ÁOK
  • DE OEC
  • Academic Medical Center (AMC)
  • Free University Medical Centre in Amsterdam (VUMC)
  • Colentina Clinical Hospital
  • Fundeni Clinical Institute
  • Mediclass Sananova SRL
  • Dr. Citu Outpatient Clinic
  • Polyclinic Private Practice Algomed SRL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNF Kinoid

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Clinical remission, defined as a CDAI score ≤ 150 points at week 8.

Secondary Outcome Measures

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
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
Biological response as defined by a decrease or normalization of calprotectin levels in stools
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).
Immunogenicity: o Anti-TNFα antibodies by Enzyme-Linked Immunosorbent Assay (ELISA) o Anti-TNFα neutralizing antibody activity o Anti-KLH antibodies by ELISA

Full Information

First Posted
December 17, 2010
Last Updated
September 17, 2014
Sponsor
Neovacs
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1. Study Identification

Unique Protocol Identification Number
NCT01291810
Brief Title
Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neovacs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNF Kinoid
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
TNF Kinoid
Intervention Description
TNF Kinoid
Intervention Type
Biological
Intervention Name(s)
WFI
Intervention Description
WFI
Primary Outcome Measure Information:
Title
Clinical remission, defined as a CDAI score ≤ 150 points at week 8.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Biological response as defined by a decrease or normalization of calprotectin levels in stools
Time Frame
Week 12
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Imelda Clinic
City
Bonheiden
Country
Belgium
Facility Name
Cliniques Universitaires St Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Facility Name
Katholiek Unversiteit van Leuven
City
Leuven
Country
Belgium
Facility Name
University Multiprofile Hospital St. Georgi
City
Plovdiv
Country
Bulgaria
Facility Name
Alexandrovska University Hospital
City
Sofia
Country
Bulgaria
Facility Name
Medical Institute- Ministry of Interior Clinic of Gastroenterology
City
Sofia
Country
Bulgaria
Facility Name
MMA Clinic of Gastroenterology
City
Sofia
Country
Bulgaria
Facility Name
UMHAT "St. Ivan Rilsky"
City
Sofia
Country
Bulgaria
Facility Name
UMHAT Queen Yoanna - ISUL
City
Sofia
Country
Bulgaria
Facility Name
Clinic of Gastroenterology/ University Hospital Varna
City
Varna
Country
Bulgaria
Facility Name
Clinical Hospital Centre Rijeka
City
Rijeka
Country
Croatia
Facility Name
General Hospital Zadar
City
Zadar
Country
Croatia
Facility Name
Clinical Hospital Centre Zagreb,
City
Zagreb
Country
Croatia
Facility Name
University Hospital Dubrava
City
Zagreb
Country
Croatia
Facility Name
Faculty Hospital in Hradec Králové
City
Hradec Králové
Country
Czech Republic
Facility Name
Faculty Hospital Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
IBD Clinical and Research Centre
City
Prague
Country
Czech Republic
Facility Name
CHU Hôpital Nord
City
Amiens
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Bordeaux
Country
France
Facility Name
CHU Caen
City
Caen
Country
France
Facility Name
CHU Côte de Nacre
City
Caen
Country
France
Facility Name
Hopital Beaujon (APHP)
City
Clichy
Country
France
Facility Name
Hôpital de Bicêtre
City
Le Kremlin-Bicêtre
Country
France
Facility Name
Hôpital A Huriez CHRU Lille
City
Lille
Country
France
Facility Name
CHU Nancy Hôpital Brabois
City
Nancy
Country
France
Facility Name
CHU de Nice Hôpital de l'Archet
City
Nice
Country
France
Facility Name
Hôpital St Louis
City
Paris
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
CHU Rangueil
City
Toulouse
Country
France
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
Country
Germany
Facility Name
Gastroenterologische Spezialpraxis
City
Berlin
Country
Germany
Facility Name
Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte
City
Berlin
Country
Germany
Facility Name
Klinikum Braunschweig
City
Braunschweig
Country
Germany
Facility Name
Klinik für Allg. Innere Medizin, Gastroenterologie und Diabetologie, Kliniken-Essen-Mitte/Evang. Huyssenstiftung
City
Essen
Country
Germany
Facility Name
Universitätsklinik und Poliklinik für Innere Medizin I
City
Halle
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg
City
Hamburg
Country
Germany
Facility Name
Hamburgisches Forschungsinstitut für CED
City
Hamburg
Country
Germany
Facility Name
I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
University Hospital Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne
City
Herne
Country
Germany
Facility Name
Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie
City
Jena
Country
Germany
Facility Name
Klinik für Innere Medizin I
City
Kiel
Country
Germany
Facility Name
Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH
City
Köln
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten
City
Leipzig
Country
Germany
Facility Name
I. Med. Klinik und Poliklinik
City
Mainz
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem ÁOK
City
Budapest
Country
Hungary
Facility Name
DE OEC
City
Debrecen
Country
Hungary
Facility Name
Academic Medical Center (AMC)
City
Amsterdam
Country
Netherlands
Facility Name
Free University Medical Centre in Amsterdam (VUMC)
City
Amsterdam
Country
Netherlands
Facility Name
Colentina Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
Fundeni Clinical Institute
City
Bucharest
Country
Romania
Facility Name
Mediclass Sananova SRL
City
Bucharest
Country
Romania
Facility Name
Dr. Citu Outpatient Clinic
City
Timisoara
Country
Romania
Facility Name
Polyclinic Private Practice Algomed SRL
City
Timisoara
Country
Romania

12. IPD Sharing Statement

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Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

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