Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

Phase 2

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT01291810
• Lead Sponsor: Neovacs

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-17
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2012-10
• Study Completion: 2014-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Clinical remission, defined as a CDAI score ≤ 150 points at week 8.	Week 8

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (58)

Imelda Clinic; 🇧🇪 Bonheiden, Belgium

Cliniques Universitaires St Luc; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, 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

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