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Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Neovacs
ClinicalTrials.gov Identifier:
NCT01291810
First received: December 17, 2010
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
 Biological: TNF Kinoid
Biological: WFI
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Neovacs:

Primary Outcome Measures:
  • Clinical remission, defined as a CDAI score ≤ 150 points at week 8. [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Biological response as defined by a decrease or normalization of calprotectin levels in stools [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: February 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TNF Kinoid Biological: TNF Kinoid
TNF Kinoid
Placebo Comparator: Placebo Biological: WFI
WFI

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291810

  Show 58 Study Locations
Sponsors and Collaborators
Neovacs
  More Information

No publications provided

Responsible Party: Neovacs
ClinicalTrials.gov Identifier: NCT01291810     History of Changes
Other Study ID Numbers: TNF-K-005
Study First Received: December 17, 2010
Last Updated: January 10, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Netherlands: Ministry of Health, Welfare and Sport
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Croatia: Agency for Medicinal Product and Medical Devices
Romania: National Medicines Agency
Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 13, 2013