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

Neovacs

Status and phase

Completed

Phase 2

Phase 1

Conditions

Crohn's Disease

Treatments

Biological: TNFa Kinoid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00808262

TNF-K-001

Details and patient eligibility

About

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

Enrollment

21 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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