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Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease
This study is currently recruiting participants.
Verified by Neovacs, December 2008
Sponsored by: Neovacs
Information provided by: Neovacs
ClinicalTrials.gov Identifier: NCT00808262
  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 I
Phase II

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment: 18
Study Start Date: October 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TNFa Kinoid dose 1: Experimental Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28
TNFa Kinoid dose 2: Experimental Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28
TNFa Kinoid dose 3: Experimental 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808262

Contacts
Contact: Pierre Vandepapeliere, MD, PhD +33(0)153102640 pvandepapeliere@neovacs.com

Locations
South Africa
Parexel George Recruiting
George, South Africa
Contact: Dawie Kruger, MD            
Principal Investigator: Dawie Kruger, MD            
Farmovs Parexel Not yet recruiting
Bloemfontein, South Africa
Contact: François Burger, MD            
Principal Investigator: François Burger, MD            
South Africa, Eastern Cape
Parexel Port Elizabeth Recruiting
Port Elizabeth, Eastern Cape, South Africa
Contact: Benji Pretorius, MD            
Contact: Frans-Peter Botha, MD            
Principal Investigator: Benji Pretorius, MD            
Switzerland
Universitätsspital Zürich Not yet recruiting
Zurich, Switzerland
Contact: Gerhard Rogler, MD, PhD            
Principal Investigator: Gerhard Rogler, MD            
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Switzerland
Contact: Pierre Michetti, MD, PhD            
Principal Investigator: Pierre Michetti, MD, PhD            
Sponsors and Collaborators
Neovacs
Investigators
Study Director: Pierre Vandepapeliere, MD, PhD Neovacs
  More Information

Responsible Party: Neovacs SA ( Pierre Vandepapeliere, CMO )
Study ID Numbers: TNFa-K-001
Study First Received: December 12, 2008
Last Updated: December 12, 2008
ClinicalTrials.gov Identifier: NCT00808262  
Health Authority: South Africa: Medicines Control Council

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

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 14, 2009