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

NCT00808262 | Completed Phase 1 DMC

• 1 other identifier: TNF-K-001
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Crohn's Disease

Keywords

anti-TNFa; immunization; kinoid; crohn's disease

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Whole study period

Secondary Outcomes (1)

• Antibody response

  Day 38

Study Arms (3)

TNFa Kinoid dose 1

EXPERIMENTAL

Biological: TNFa Kinoid

TNFa Kinoid dose 2

EXPERIMENTAL

Biological: TNFa Kinoid

TNFa Kinoid dose 3

EXPERIMENTAL

Biological: TNFa Kinoid

Interventions

TNFa Kinoid BIOLOGICAL

TNFa kinoid at days 0, 7, 28

TNFa Kinoid dose 1; TNFa Kinoid dose 2; TNFa Kinoid dose 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neovacs: lead

Study Sites (6)

Durbanville Medi-Clinic

Cape Town, Cape, 7550, South Africa

Location

Parexel Port Elizabeth

Port Elizabeth, Eastern Cape, South Africa

Location

Farmovs Parexel

Bloemfontein, South Africa

Location

Parexel George

George, South Africa

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Pierre Vandepapeliere, MD, PhD

  Neovacs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

CH (2); ZA (4)