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Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

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ClinicalTrials.gov Identifier: NCT01291810
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: TNF Kinoid Biological: WFI Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: TNF Kinoid Biological: TNF Kinoid
TNF Kinoid

Placebo Comparator: Placebo Biological: WFI
WFI




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

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291810


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Sponsors and Collaborators
Neovacs

Responsible Party: Neovacs
ClinicalTrials.gov Identifier: NCT01291810     History of Changes
Other Study ID Numbers: TNF-K-005
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

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