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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808262
• Other study ID #: TNF-K-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 12, 2008
• Last updated: June 7, 2011
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Neovacs
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• TNFa Kinoid
TNFa kinoid at days 0, 7, 28

Locations

Country	Name	City	State
South Africa	Farmovs Parexel	Bloemfontein
South Africa	Durbanville Medi-Clinic	Cape Town	Cape
South Africa	Parexel George	George
South Africa	Parexel Port Elizabeth	Port Elizabeth	Eastern Cape
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Universitätsspital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Neovacs

Countries where clinical trial is conducted

South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events		Whole study period	Yes
Secondary	Antibody response		Day 38	No