Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

NCT ID: NCT01291810

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-05-31

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TNF Kinoid

Group Type: EXPERIMENTAL

TNF Kinoid

Intervention Type: BIOLOGICAL

TNF Kinoid

Placebo

Group Type: PLACEBO_COMPARATOR

WFI

Intervention Type: BIOLOGICAL

WFI

Interventions

TNF Kinoid

TNF Kinoid

Intervention Type: BIOLOGICAL

WFI

WFI

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neovacs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imelda Clinic

Bonheiden, , Belgium

Cliniques Universitaires St Luc

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Katholiek Unversiteit van Leuven

Leuven, , Belgium

University Multiprofile Hospital St. Georgi

Plovdiv, , 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

Sofia, , Bulgaria

Clinic of Gastroenterology/ University Hospital Varna

Varna, , Bulgaria

Clinical Hospital Centre Rijeka

Rijeka, , Croatia

General Hospital Zadar

Zadar, , Croatia

Clinical Hospital Centre Zagreb,

Zagreb, , Croatia

University Hospital Dubrava

Zagreb, , Croatia

Faculty Hospital in Hradec Králové

Hradec Králové, , Czechia

Faculty Hospital Olomouc

Olomouc, , Czechia

IBD Clinical and Research Centre

Prague, , Czechia

CHU Hôpital Nord

Amiens, , France

Hôpital Haut-Lévêque

Bordeaux, , France

CHU Caen

Caen, , France

CHU Côte de Nacre

Caen, , France

Hopital Beaujon (APHP)

Clichy, , France

Hôpital de Bicêtre

Le Kremlin-Bicêtre, , France

Hôpital A Huriez CHRU Lille

Lille, , France

CHU Nancy Hôpital Brabois

Nancy, , France

CHU de Nice Hôpital de l'Archet

Nice, , France

Hôpital St Louis

Paris, , France

CHU Rouen

Rouen, , France

CHU Rangueil

Toulouse, , France

Charité Campus Virchow-Klinikum

Berlin, , Germany

Gastroenterologische Spezialpraxis

Berlin, , Germany

Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte

Berlin, , Germany

Klinikum Braunschweig

Braunschweig, , Germany

Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH

Cologne, , Germany

Klinik für Allg. Innere Medizin, Gastroenterologie und Diabetologie, Kliniken-Essen-Mitte/Evang. Huyssenstiftung

Essen, , Germany

Universitätsklinik und Poliklinik für Innere Medizin I

Halle, , Germany

Asklepios Westklinikum Hamburg

Hamburg, , Germany

Hamburgisches Forschungsinstitut für CED

Hamburg, , Germany

I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

University Hospital Heidelberg

Heidelberg, , Germany

Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne

Herne, , Germany

Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie

Jena, , Germany

Klinik für Innere Medizin I

Kiel, , Germany

Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten

Leipzig, , Germany

I. Med. Klinik und Poliklinik

Mainz, , Germany

Universitätsklinikum Münster

Münster, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza

Budapest, , Hungary

Semmelweis Egyetem ÁOK

Budapest, , Hungary

DE OEC

Debrecen, , Hungary

Academic Medical Center (AMC)

Amsterdam, , Netherlands

Free University Medical Centre in Amsterdam (VUMC)

Amsterdam, , Netherlands

Colentina Clinical Hospital

Bucharest, , Romania

Fundeni Clinical Institute

Bucharest, , Romania

Mediclass Sananova SRL

Bucharest, , Romania

Dr. Citu Outpatient Clinic

Timișoara, , Romania

Polyclinic Private Practice Algomed SRL

Timișoara, , Romania

Countries

Belgium; Bulgaria; Croatia; Czechia; France; Germany; Hungary; Netherlands; Romania

Other Identifiers

TNF-K-005

Identifier Type: -

Identifier Source: org_study_id