Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

September 17, 2014 updated by: Neovacs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • Imelda Clinic
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St Luc
      • Gent, Belgium
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium
        • Katholiek Unversiteit van Leuven
  • Bulgaria
      • Plovdiv, Bulgaria
        • University Multiprofile Hospital St. Georgi
      • Sofia, Bulgaria
        • Alexandrovska University Hospital
      • Sofia, Bulgaria
        • Medical Institute- Ministry of Interior Clinic of Gastroenterology
      • Sofia, Bulgaria
        • MMA Clinic of Gastroenterology
      • Sofia, Bulgaria
        • UMHAT "St. Ivan Rilsky"
      • Sofia, Bulgaria
        • UMHAT Queen Yoanna - ISUL
      • Varna, Bulgaria
        • Clinic of Gastroenterology/ University Hospital Varna
  • Croatia
      • Rijeka, Croatia
        • Clinical Hospital Centre Rijeka
      • Zadar, Croatia
        • General Hospital Zadar
      • Zagreb, Croatia
        • Clinical Hospital Centre Zagreb,
      • Zagreb, Croatia
        • University Hospital Dubrava
  • Czech Republic
      • Hradec Králové, Czech Republic
        • Faculty Hospital in Hradec Králové
      • Olomouc, Czech Republic
        • Faculty Hospital Olomouc
      • Prague, Czech Republic
        • IBD Clinical and Research centre
  • France
      • Amiens, France
        • CHU Hopital Nord
      • Bordeaux, France
        • Hôpital Haut-Lévêque
      • Caen, France
        • CHU caen
      • Caen, France
        • CHU Côte de Nacre
      • Clichy, France
        • Hôpital Beaujon (APHP)
      • Le Kremlin-Bicêtre, France
        • Hopital de Bicetre
      • Lille, France
        • Hôpital A Huriez CHRU Lille
      • Nancy, France
        • Chu Nancy Hopital Brabois
      • Nice, France
        • CHU De Nice Hopital De l'Archet
      • Paris, France
        • Hôpital St Louis
      • Rouen, France
        • CHU Rouen
      • Toulouse, France
        • CHU Rangueil
  • Germany
      • Berlin, Germany
        • Charité Campus Virchow-Klinikum
      • Berlin, Germany
        • Gastroenterologische Spezialpraxis
      • Berlin, Germany
        • Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte
      • Braunschweig, Germany
        • Klinikum Braunschweig
      • Essen, Germany
        • Klinik für Allg. Innere Medizin, Gastroenterologie und Diabetologie, Kliniken-Essen-Mitte/Evang. Huyssenstiftung
      • Halle, Germany
        • Universitatsklinik Und Poliklinik Fur Innere Medizin I
      • Hamburg, Germany
        • Asklepios Westklinikum Hamburg
      • Hamburg, Germany
        • Hamburgisches Forschungsinstitut für CED
      • Hamburg, Germany
        • I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany
        • University Hospital Heidelberg
      • Herne, Germany
        • Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne
      • Jena, Germany
        • Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie
      • Kiel, Germany
        • Klinik für Innere Medizin I
      • Köln, Germany
        • Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH
      • Leipzig, Germany
        • Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten
      • Mainz, Germany
        • I. Med. Klinik und Poliklinik
      • Münster, Germany
        • Universitatsklinikum Munster
      • Ulm, Germany
        • Universitatsklinikum Ulm
  • Hungary
      • Budapest, Hungary
        • Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza
      • Budapest, Hungary
        • Semmelweis Egyetem AOK
      • Debrecen, Hungary
        • DE OEC
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center (AMC)
      • Amsterdam, Netherlands
        • Free University Medical Centre in Amsterdam (VUMC)
  • Romania
      • Bucharest, Romania
        • Colentina Clinical Hospital
      • Bucharest, Romania
        • Fundeni Clinical Institute
      • Bucharest, Romania
        • Mediclass Sananova SRL
      • Timisoara, Romania
        • Dr. Citu Outpatient Clinic
      • Timisoara, Romania
        • Polyclinic Private Practice Algomed SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: WFI
WFI
Experimental: TNF Kinoid
Biological: TNF Kinoid
TNF Kinoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical remission, defined as a CDAI score ≤ 150 points at week 8.
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
week 12
Biological response as defined by a decrease or normalization of calprotectin levels in stools
Time Frame: Week 12
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
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
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neovacs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNF-K-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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