Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291810
• Other study ID #: TNF-K-005
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2010
• Last updated: September 17, 2014
• Start date: February 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Neovacs
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutNetherlands: Ministry of Health, Welfare and SportBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlCroatia: Agency for Medicinal Product and Medical DevicesRomania: National Medicines AgencyHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-TNFa therapy.

Exclusion Criteria:

1. Primary non-response to a previously received treatment directed against TNFa Or Intolerance related to the primary pharmacological effect of anti-TNFa 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• TNF Kinoid
TNF Kinoid
• WFI
WFI

Locations

Country	Name	City	State
Belgium	Imelda Clinic	Bonheiden
Belgium	Cliniques Universitaires St Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Katholiek Unversiteit van Leuven	Leuven
Bulgaria	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
Croatia	Clinical Hospital Centre Rijeka	Rijeka
Croatia	General Hospital Zadar	Zadar
Croatia	Clinical Hospital Centre Zagreb,	Zagreb
Croatia	University Hospital Dubrava	Zagreb
Czech Republic	Faculty Hospital in Hradec Králové	Hradec Králové
Czech Republic	Faculty Hospital Olomouc	Olomouc
Czech Republic	IBD Clinical and Research Centre	Prague
France	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
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Gastroenterologische Spezialpraxis	Berlin
Germany	Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte	Berlin
Germany	Klinikum Braunschweig	Braunschweig
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	Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH	Köln
Germany	Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten	Leipzig
Germany	I. Med. Klinik und Poliklinik	Mainz
Germany	Universitätsklinikum Münster	Münster
Germany	Universitätsklinikum Ulm	Ulm
Hungary	Fovárosi Önkormányzat Péterfy Sándor utcai Kórháza	Budapest
Hungary	Semmelweis Egyetem ÁOK	Budapest
Hungary	DE OEC	Debrecen
Netherlands	Academic Medical Center (AMC)	Amsterdam
Netherlands	Free University Medical Centre in Amsterdam (VUMC)	Amsterdam
Romania	Colentina Clinical Hospital	Bucharest
Romania	Fundeni Clinical Institute	Bucharest
Romania	Mediclass Sananova SRL	Bucharest
Romania	Dr. Citu Outpatient Clinic	Timisoara
Romania	Polyclinic Private Practice Algomed SRL	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
Neovacs

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Croatia,  Czech Republic,  France,  Germany,  Hungary,  Netherlands,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission, defined as a CDAI score = 150 points at week 8.		Week 8	Yes
Secondary	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	No
Secondary	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	No
Secondary	Biological response as defined by a decrease or normalization of calprotectin levels in stools		Week 12	No
Secondary	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	Yes
Secondary	Immunogenicity: o Anti-TNFa antibodies by Enzyme-Linked Immunosorbent Assay (ELISA) o Anti-TNFa neutralizing antibody activity o Anti-KLH antibodies by ELISA		week 12	No