Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

NCT01291810 | Completed Phase 2 DMC

• 1 other identifier: TNF-K-005
• Study Type: interventional
• Target: 66
• Locations: 9 countries
• Sites: 58

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

Outcome Measures

Primary Outcomes (1)

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

  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

  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

  week 12

• Biological response as defined by a decrease or normalization of calprotectin levels in stools

  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).

  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

  week 12

Study Arms (2)

TNF Kinoid

EXPERIMENTAL

Biological: TNF Kinoid

Placebo

PLACEBO COMPARATOR

Biological: WFI

Interventions

TNF Kinoid BIOLOGICAL

TNF Kinoid

TNF Kinoid

WFI BIOLOGICAL

WFI

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neovacs: lead

Study Sites (58)

Imelda Clinic

Bonheiden, Belgium

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Katholiek Unversiteit van Leuven

Leuven, Belgium

Location

University Multiprofile Hospital St. Georgi

Plovdiv, Bulgaria

Location

Alexandrovska University Hospital

Sofia, Bulgaria

Location

Medical Institute- Ministry of Interior Clinic of Gastroenterology

Sofia, Bulgaria

Location

MMA Clinic of Gastroenterology

Sofia, Bulgaria

Location

UMHAT "St. Ivan Rilsky"

Sofia, Bulgaria

Location

UMHAT Queen Yoanna - ISUL

Sofia, Bulgaria

Location

Clinic of Gastroenterology/ University Hospital Varna

Varna, Bulgaria

Location

Clinical Hospital Centre Rijeka

Rijeka, Croatia

Location

General Hospital Zadar

Zadar, Croatia

Location

Clinical Hospital Centre Zagreb,

Zagreb, Croatia

Location

University Hospital Dubrava

Zagreb, Croatia

Location

Faculty Hospital in Hradec Králové

Hradec Králové, Czechia

Location

Faculty Hospital Olomouc

Olomouc, Czechia

Location

IBD Clinical and Research Centre

Prague, Czechia

Location

CHU Hôpital Nord

Amiens, France

Location

Hôpital Haut-Lévêque

Bordeaux, France

Location

CHU Caen

Caen, France

Location

CHU Côte de Nacre

Caen, France

Location

Hopital Beaujon (APHP)

Clichy, France

Location

Hôpital de Bicêtre

Le Kremlin-Bicêtre, France

Location

Hôpital A Huriez CHRU Lille

Lille, France

Location

CHU Nancy Hôpital Brabois

Nancy, France

Location

CHU de Nice Hôpital de l'Archet

Nice, France

Location

Hôpital St Louis

Paris, France

Location

CHU Rouen

Rouen, France

Location

CHU Rangueil

Toulouse, France

Location

Charité Campus Virchow-Klinikum

Berlin, Germany

Location

Gastroenterologische Spezialpraxis

Berlin, Germany

Location

Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte

Berlin, Germany

Location

Klinikum Braunschweig

Braunschweig, Germany

Location

Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH

Cologne, Germany

Location

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

Essen, Germany

Location

Universitätsklinik und Poliklinik für Innere Medizin I

Halle, Germany

Location

Asklepios Westklinikum Hamburg

Hamburg, Germany

Location

Hamburgisches Forschungsinstitut für CED

Hamburg, Germany

Location

I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne

Herne, Germany

Location

Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie

Jena, Germany

Location

Klinik für Innere Medizin I

Kiel, Germany

Location

Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten

Leipzig, Germany

Location

I. Med. Klinik und Poliklinik

Mainz, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza

Budapest, Hungary

Location

Semmelweis Egyetem ÁOK

Budapest, Hungary

Location

DE OEC

Debrecen, Hungary

Location

Academic Medical Center (AMC)

Amsterdam, Netherlands

Location

Free University Medical Centre in Amsterdam (VUMC)

Amsterdam, Netherlands

Location

Colentina Clinical Hospital

Bucharest, Romania

Location

Fundeni Clinical Institute

Bucharest, Romania

Location

Mediclass Sananova SRL

Bucharest, Romania

Location

Dr. Citu Outpatient Clinic

Timișoara, Romania

Location

Polyclinic Private Practice Algomed SRL

Timișoara, Romania

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: February 8, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2014
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

CZ (3); FR (12); HU (3); BE (4); CR (4); DE (18); NL (2); RO (5); BU (7)