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    Summary
    EudraCT Number:2010-019996-32
    Sponsor's Protocol Code Number:TNF-K-005
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2010-019996-32
    A.3Full title of the trial
    A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFα-Kinoid in adult subjects with Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II, randomized, double-blind, placebo-controlled study to
    evaluate the clinical efficacy, safety and immunogenicity of
    Neovacs'TNFα-Kinoid in adult subjects with Crohn's Disease
    A.4.1Sponsor's protocol code numberTNF-K-005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNeovacs SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNeovacs
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeovacs SA
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address 3-5 Impasse Reille
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75014
    B.5.3.4CountryFrance
    B.5.4Telephone number+331 53 10 26 40
    B.5.5Fax number+331 53 10 93 03
    B.5.6E-mailpvandepapeliere@neovacs.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTNFα-Kinoid
    D.3.2Product code TNF-K
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned yet
    D.3.9.2Current sponsor codeTNFα-Kinoid or TNFα-K or Kinoid
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEmulsion for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the clinical efficacy of TNF-K in adult subjects with moderate to severe active CD. Specifically, the study will assess the induction of clinical remission (CDAI≤150)
    E.2.2Secondary objectives of the trial
    • To assess clinical response by CDAI (CDAI-70 and CDAI-100)
    • To assess mucosal improvement and healing by ileocolonoscopy
    • To assess changes in biological markers of disease activity
    • To assess microscopic and biological changes in ileocolonic mucosal tissue
    • To evaluate the safety of TNF-K treatment in subjects with moderate to severe active CD
    • To evaluate the anti-TNF-α and anti-Keyhole Limpet Hemocyanin (anti-KLH) antibody responses induced by
    TNF K
    • To evaluate the neutralizing anti-TNF-α antibody response induced by TNF-K
    E.2.3Trial contains a sub-study No
    E.3Principal 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 mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
    4.Either have developed secondary resistance to one or two anti-TNFα therapy. Secondary resistance must have followed at least 6 months of continuous anti-TNFα therapy during which a positive clinical response has been observed, according to the Investigator.
    and/or
    Have developed intolerance to one or two anti-TNFα treatment, provided that the observed adverse events are thought to be unrelated to the primary pharmacological effect of these agents (i.e. TNFα blockade). Subjects can have received only one or more anti-TNF-α 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;
    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
    E.4Principal exclusion criteria
    1.Primary non-response to a previously received treatment directed against TNF α
    Or
    Intolerance related to the primary pharmacological effect of anti-TNF-α 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;
    • TNFα 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-α blockers within 12 weeks or 5 half lives of the first administration of study drug, whichever is longer.

    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    The same primary efficacy endpoint will be used for the interim and primary analyses, i.e., clinical remission, defined as a CDAI score ≤ 150 points at week 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 8
    E.5.2Secondary end point(s)
    1. Clinical responses, defined as a decrease of at least 70 points (CDAI-
    70)and at least 100 points (CDAI-100) in the CDAI score at week 8 vs
    baseline
    2. Endoscopic response, defined as a reduction of at least 50% in the
    Crohn's Disease Endoscopic Index of Severity (CDEIS) score or in the
    Simple Endoscopic Score for Crohn's Disease (SES-CD) at week 12 vs
    baseline
    3. Mucosal healing defined as the disappearance of all ulcerations at
    week 12
    4. Steroid sparing and steroid-free clinical remission by week 28
    5. Biological response as defined by a decrease or normalization of
    calprotectin levels in stool
    6. Biological response as defined by a decrease or normalization of CRP
    levels in serum
    7. Time to first occurence of clinical response and of clinical remission
    8. Changes in the Quality of Life, as measured by the Inflammatory
    Bowel Disease Questionnaire (IBDQ).
    9. Association between anti-TNFα antibody levels and changes in the
    CDAI and the endoscopic scores
    10. Association between anti-drug-antibodies (ADA) at baseline and
    changes in the CDAI and the endoscopic scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. week 8
    2. week 12
    3. week 12
    4. week 28
    8. 4 and 8 weeks after each study product administration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    Croatia
    Czech Republic
    France
    Germany
    Hungary
    Netherlands
    Romania
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 132
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 132
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal standard therapy for this condition
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-21
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