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    Summary
    EudraCT Number:2005-003827-38
    Sponsor's Protocol Code Number:CL004_282
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-07
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2005-003827-38
    A.3Full title of the trial
    A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease
    A.4.1Sponsor's protocol code numberCL004_282
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChemoCentryx, Inc
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameCCX282-B
    D.3.2Product code CCX282-B
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCCX282-B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.
    MedDRA Classification
    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 efficacy objective of the induction period (first 12 weeks) of this study is to determine the effect on Crohn’s disease severity as measured by Crohn’s Disease Activity Index (CDAI) scores of three doses regimens of CCX282-B compared with placebo, administered orally once daily for up to twelve consecutive weeks to subjects with moderate to severe Crohn’s disease.
    The primary efficacy objective of the maintenance period (last 36 weeks) of this study is to determine the effect of CCX282-B compared to placebo on maintenance of response as measured by CDAI over a 36-week period.
    E.2.2Secondary objectives of the trial
    Induction Period:
    -Safety and tolerability of 3 dose of oral regimens of CCX282-B compared with Placebo for up to 12 consecutive weeks
    -Effect of CCX282-B compared with placebo on:
    .Histopathological and endoscopic visual appearance of the ileal and colonic Mucosa
    .Health-related quality of life using Short Form-36 version 2
    .Serum C-reactive protein concentrations
    .Dose-response relationship for effects of 3 dose regimens of CCX282-B on CD activity
    .If CCX282-B compared with placebo results in reduction in glucocorticoid use
    .Population pharmacokinetic profile of CCX282-B in subject with moderate to severe CD
    Maintenance Period:
    -Safety and tolerability of 250 mg twice daily oral CCX282-B compared with placebo for up to 36 consecutive weeks
    -Effect of CCX282-B compared with placebo on:
    .Health-related quality of life using Short Form-36 version 2
    .Serum C-reactive protein concentrations
    .if glucocorticoid use reduced in CCX282-B group versus placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject must meet all of the following inclusion criteria in order to enter the study:

    1. The subject is male or female, at least 18 years of age.

    2. At study entry the subject has active, moderate to severe Crohn’s disease (documented by X rays or colonoscopy) with evidence of small bowel and/or colonic disease. CDAI at study entry must be between 250 and 450, inclusive. Fasting serum CRP concentration during the Screening period must be above 7.5 mg/L.

    3. If the subject has been receiving therapy for Crohn’s disease (methotrexate, azathioprine, 6-mercaptopurine, and/or up to 20 mg per day of prednisone or prednisone-equivalent), s/he must be on a stable regimen of this medication(s) beginning at least four weeks prior to study entry and is expected to continue on a stable dose of these medications throughout at least the first 196 days. Glucocorticoid doses could be tapered after the Study Day 57 visit, and must be tapered after the Study Day 113 visit. 5-ASA therapy for Crohn’s disease is allowed during the study.

    4. No more than 100 cm of the subject’s small bowel has been resected.

    5. If a female of childbearing potential, or if a male whose partner is a woman of childbearing potential, the subject must agree to use adequate contraception during the 364 days of the study drug administration. Adequate contraception is defined as use by the female partner of any form of hormonal contraception or intra-uterine device, or use by at least one of the partners of a barrier method of contraception witn a spermicide. Promise of abstinence alone is not considered adequate contraception.

    6. The subject is willing and able to provide written Informed Consent prior to screening and to comply with the requirements of the study protocol.

    7. If taking oral antibiotics chronically, the subject must have been using these continuously for at least 1 month prior to randomization and at stable doses for at least 2 weeks prior to randomization.

    All subjects who complete the 12-week induction period of the study will be eligible to enter the active treatment period. Subjects who are in the 28-day follow-up period at the time of implementation of Amendment 1 of the protocol, will also be allowed to enter the 4-week active treatment period following their Day 113F visit. These subjects may come in early for their Day 113F visit. Subjects who have completed the study by the time of implementation of Amendment 1 of the protocol, will also be allowed to enter the 4-week active treatment period, if they are within 3 months after completing the study. These subjects must come to the study center for a Day 113F2 visit. All subjects must sign written informed consent to continue in the active treatment period of the study.

    The subject must meet all the following criteria to continue in the maintenance period of the study:
    1. CDAI decrease from baseline (measured during screening period) to Day 113 of at least 70 points;
    2. If the subject has been receiving therapy for Crohn’s disease (methotrexate, azathioprine, 6-mercaptopurine, and/or up to 20 mg per day of prednisone or prednisone-equivalent), s/he must be on a stable regimen of this medication(s) from Day 113 through at least Day 197. Glucocorticoid doses must be tapered starting at the Study Day 113 visit (see section 9.4.6). 5-ASA therapy for Crohn’s disease is allowed during the study.
    3. If a female of childbearing potential, or if a male whose partner is a woman of childbearing potential, the subject must agree to use adequate contraception during the 364 days of the study drug administration. Adequate contraception is defined as use by the female partner of any form of hormonal contraception or intra-uterine device, or use by at least one of the partners of a barrier method of contraception with a spermicide. Promise of abstinence alone is not considered adequate contraception.
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria may not enter the study:

    1. If female, the subject is pregnant or has a positive pregnancy test, or is breast feeding;
    2. Medical history of hypersensitivity to any of the components of the CCX282-B formulation (microcrystalline cellulose, polyvinyl pyrrolidone, sodium lauryl sulphate, colloidal silicon dioxide, crospovidone, or sodium stearyl fumarate);
    3. The subject used cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil and/or greater than 20 mg prednisone or a prednisone-equivalent during the 4 weeks prior to study entry;
    4. The subject received treatment with a TNF inhibitor (e.g., infliximab or adalimumab) or natalizumab within 12 weeks prior to study entry;
    5. The subject has received parenteral glucocorticoids or corticotrophin within 4 weeks prior to study entry;
    6. The subject received an experimental treatment for Crohn’s disease within 4 weeks prior to study entry;
    7. The subject has a known symptomatic obstructive stricture, had bowel surgery (other than appendectomy) within 12 weeks prior to randomization and/or the subject is planned or deemed likely to require abdominal surgery related to Crohn’s disease during the study period;
    8. Subjects with ileostomies, colostomies, or rectal pouches;
    9. The subject has evidence of short bowel syndrome requiring enteral or parenteral nutritional supplementation or total parenteral nutrition;
    10. The subject has evidence of hepatitis B, hepatitis C, and/or the human immunodeficiency virus (HIV) infection based on virology tests;
    11. The subject has evidence of active tuberculosis. Chest radiographs may be acquired to rule out tuberculosis. Alternatively a screening test could be done (tuberculin skin test, QuantiFERON-TB Gold test, or T-SPOT™.TB test) to rule out TB. If the screening test is positive, chest radiographs must be obtained to rule out TB.
    12. The subject has a history of any infection requiring intravenous antibiotics, a serious local infection (e.g., cellulitis or abscess), systemic infection (e.g., pneumonia, septicemia), or gastrointestinal infection within 12 weeks of randomization;
    13. Has a diagnosis of ulcerative or indeterminate colitis;
    14. The subject has a history or presence of illicit drug use and/or alcohol abuse within the year prior to study entry;
    15. The subject has a history or presence of any form of cancer within the 5 years prior to study entry, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis, and
    16. The subject has a history or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and may prevent the subject from completing the study.
    E.5 End points
    E.5.1Primary end point(s)
    For the induction period of the study, the primary efficacy endpoint is the attainment of a clinical response (defined as a decrease from baseline in CDAI score of at least 70) at Day 57.

    For the maintenance period of the study, the primary efficacy endpoint is the attainment of a CDAI delta 70 response at the end of the active treatment period (Day 113) AND maintenance of the CDAI response at Study Day 365 (Day 197 for the interim analysis). Loss of CDAI response during the maintenance period is defined as a CDAI increase, at any time, of more than 70 points from the Day 113 value and an absolute CDAI value above 250, at any time, or the need for intervention after Day 113.

    Since there is no comparator group for the active treatment period, results from this period will only be summarized descriptively. This will include a summary of the CDAI and CRP changes during the active treatment period, as well as tapering/discontinuation of corticosteroid use during the active treatment period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over No
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last visit of last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 598
    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)
    The patient will return to standard treatment
    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 Decision2005-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-24
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