Clinical trial NCT00808262: Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Keywords: anti-TNFa
immunization
kinoid
crohn's disease
Lead sponsor: Neovacs
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: Whole study period
Secondary outcomes:
measure: Antibody response
timeFrame: Day 38
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Durbanville Medi-Clinic
state: Cape
city: Port Elizabeth
country: South Africa
facility: Parexel Port Elizabeth
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Farmovs Parexel
city: George
country: South Africa
facility: Parexel George
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Neovacs
name: Pierre Vandepapeliere, MD, PhD
role: STUDY_DIRECTOR
References: