Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease

This study has been completed.
Sponsor:
Information provided by:
Neovacs
ClinicalTrials.gov Identifier:
NCT00808262
First received: December 12, 2008
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease.


Condition Intervention Phase
Crohn's Disease
Biological: TNFa Kinoid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-label, Escalating Dose, "Optimal Two-stage", Study of TNFα-Kinoid (TNF- K) Immunization in Crohn's Disease Patients

Resource links provided by NLM:


Further study details as provided by Neovacs:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antibody response [ Time Frame: Day 38 ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TNFa Kinoid dose 1 Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28
Experimental: TNFa Kinoid dose 2 Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28
Experimental: TNFa Kinoid dose 3 Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have Active Crohn's Disease, as defined by a Crohn's Disease Activity Index (CDAI) score of >220 but ≤400, with active Crohn's disease of ileum and/or colon (Other areas may be involved if ileum and/or colon are also involved)based upon either endoscopic, histologic and/or radiographic evidence
  • Patients with active disease despite treatment with 5-ASAs or sulfasalazine, corticosteroids (prednisone, budesonide, other), AZA or 6-MP or cyclosporine or MTX or Tacrolimus, ; OR intolerant of 5-ASAs or sulfasalazine; or intolerant of antibiotics; or intolerant of corticosteroids (prednisone, budesonide, other); or intolerant of AZA or 6-MP or cyclosporine or MTX or Tacrolimus
  • Patients might have previously responded to any prior anti-TNF agents and then lost response OR might be intolerant of any prior anti-TNF agents
  • Positive skin reaction to challenge with Candida antigens
  • Written informed consent

Exclusion Criteria:

  • Prior history of tuberculosis or positive chest X ray or positive purified protein derivative skin test or positive interferon gamma TB assay
  • Signs or symptoms of clinically significant stricture of bowel.
  • Total parenteral nutrition or elemental diet required for treatment of disease or support of short bowel syndrome
  • Presence of an enteric stoma
  • Imminent or urgent surgery required for infection, abscess, bleeding or any other cause relating to their Crohn's Disease or other condition
  • History of malignancy. However, subjects with basal call carcinomas or less than 3 squamous cell carcinomas are allowed
  • History of asthma or serious allergic condition (including history of seafood allergy)
  • Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of study drug
  • History of opportunistic infection excluding oral candidiasis on steroids
  • Enteric infection as evidenced by positive stool C&S, O&P and C. difficile obtained during screening
  • Any significant or decompensated cardiac, neurologic, liver, pulmonary or renal disease
  • History of lymphoproliferative disorders
  • Clinically significant abnormal hematology values, as determined by the investigator, for hematocrit, hemoglobin, white blood cell count or platelets
  • Clinically significant abnormal blood chemistry values as determined by the investigator
  • Current significant drug or alcohol abuse as determined by the investigator
  • Positive for hepatitis C antibody or positive for hepatitis B surface antigen (HbsAg) or HIV infection
  • Surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures)
  • Participation in a clinical study (including previous participation in this study) within the previous 4 months
  • Had a primary non-response to any prior anti-TNF agents as defined by the investigator OR received any prior anti-TNF agents within the past 8 weeks prior to study entry
  • Pregnancy and lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808262

Locations
South Africa
Durbanville Medi-Clinic
Cape Town, Cape, South Africa, 7550
Parexel Port Elizabeth
Port Elizabeth, Eastern Cape, South Africa
Farmovs Parexel
Bloemfontein, South Africa
Parexel George
George, South Africa
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Sponsors and Collaborators
Neovacs
Investigators
Study Director: Pierre Vandepapeliere, MD, PhD Neovacs
  More Information

No publications provided

Responsible Party: Pierre Vandepapeliere, CMO, Neovacs SA
ClinicalTrials.gov Identifier: NCT00808262     History of Changes
Other Study ID Numbers: TNF-K-001
Study First Received: December 12, 2008
Last Updated: June 7, 2011
Health Authority: South Africa: Medicines Control Council
Switzerland: Swissmedic

Keywords provided by Neovacs:
anti-TNFa
immunization
kinoid
crohn's disease

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

ClinicalTrials.gov processed this record on October 16, 2014