Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

Neovacs

Status and phase

Completed

Phase 2

Conditions

Crohn's Disease

Treatments

Biological: TNF Kinoid

Biological: WFI

Study type

Interventional

Funder types

Industry

Identifiers

NCT01291810

TNF-K-005

Details and patient eligibility

About

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising.

The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

Enrollment

66 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female aged 18 to 65 years, inclusive.
Have had a diagnosis of Crohn's disease for at least 6 months.
Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
Have developed secondary resistance to anti-TNFα therapy.

Exclusion criteria

Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
Treatment with immunosuppressive or immunomodulatory drugs