A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's Disease

• Conditions: Moderate to severe Crohn's Disease; MedDRA version: 14.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2010-019996-32-BG
• Lead Sponsor: eovacs SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-24
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1.Male or female aged 18 to 65 years, inclusive.
2.Have had a diagnosis of Crohn’s disease for at least 6 months.
3.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.
4.Have developed secondary resistance to anti-TNF-a therapy. Secondary resistance must have followed at least 6 months of continuous anti-TNFa therapy during which a positive clinical response has been observed, according to the Investigator. Subjects can have received only one anti-TNF-a agent, and must have discontinued this treatment as follows:
•Infliximab: a wash-out period of 8 weeks prior to the first administration of study drug;
•Adalimumab: a wash-out period of 4 weeks prior to the first administration of study drug;
•Certolizumab: a wash-out period of 8 weeks prior to the first administration of study drug;
and/or
Have developed intolerance to an anti-TNF-a treatment, provided that the observed adverse events are thought to be unrelated to the primary pharmacological effect of these agents (i.e. TNF-a blockade).
5.If receiving the medications listed below, must meet the outlined criteria:
•Systemic corticosteroids: up to 25 mg/day of prednisone or equivalent, ongoing for at least 8 weeks, and with a stable dose for at least 2 weeks prior to the first administration of study drug;
•Budesonide: up to 6 mg/day, ongoing for at least 8 weeks, and with a stable dose for at least 2 weeks prior to the first administration of study drug;
•Methotrexate: up to 25 mg/week, ongoing for at least 8 weeks, and with a stable dose for at least 4 weeks prior to the first administration of study drug;
•Azathioprine: up to 2.5 mg/kg/day, ongoing for at least 8 weeks, and with a stable dose for at least 4 weeks prior to the first administration of study drug;
•Mercaptopurine: up to 1.5 mg/kg/day, ongoing for at least 8 weeks, and with a stable dose for at least 4 weeks prior to the first administration of study drug;
•Antibiotics (metronidazole at 15-20 mg/kg per day and/or ciprofloxacin 500 mg bid) are allowed if ongoing for at least 4 weeks, and with a stable dose for at least 2 weeks prior to the first administration of study drug;
•Sulfasalazine and mesalazine ongoing for at least 8 weeks, and with a stable dose of maximum 4g per day for at least 4 weeks prior to the first administration of study drug

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 132
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Primary non-response to a previously received treatment directed against TNF a
Or
Intolerance related to the primary pharmacological effect of anti-TNF-a such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
2.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.
3.Treatment with more than 2 doses over 30 mg of rectally administered corticosteroids in the 14 days preceding the first administration of study drug.
4.Treatment with immunosuppressive or immunomodulatory drugs, including, but not limited to:
•B-cell depleting therapy (e.g., anti-CD20, anti-CD22) within 1 year of the first administration of study drug;
•Cyclophosphamide within 12 weeks of the first administration of study drug;
•Cyclosporine within 12 weeks of the first administration of study drug;
•TNFa blockers other than infliximab, adalimumab or certolizumab within 12 weeks or 5 half lives of the first; administration of study drug, whichever is longer
• Biological agents other than TNF-a blockers within 12 weeks or 5 half lives of the first administration of study drug, whichever is longer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified