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Completed

NCT Number: NCT01291810

Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Imelda Clinic, Bonheiden, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

TNF Kinoid

Biological

TNF Kinoid

WFI

Biological

WFI

Primary outcomes

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

    Time frame: Week 8

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: Week 12

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Neovacs

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Feb 8, 2011
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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