Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01291810
• Date of registration: 17/12/2010
• Prospective Registration: Yes
• Primary sponsor: Neovacs
• Public title: Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients
• Scientific title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFa-Kinoid in Adult Subjects With Crohn's Disease
• Date of first enrolment: February 2011
• Target sample size: 66
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01291810
• 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
• Phase: Phase 2

Countries of recruitment

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

Key inclusion & exclusion 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-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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: WFI

Biological: TNF Kinoid

Primary Outcome(s)

Clinical remission, defined as a CDAI score = 150 points at week 8. [Time Frame: Week 8]

Secondary Outcome(s)

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]

Immunogenicity: o Anti-TNFa antibodies by Enzyme-Linked Immunosorbent Assay (ELISA) o Anti-TNFa neutralizing antibody activity o Anti-KLH antibodies by ELISA [Time Frame: week 12]

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]

Biological response as defined by a decrease or normalization of calprotectin levels in stools [Time Frame: Week 12]

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]

Secondary ID(s)

TNF-K-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors