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    EudraCT Number:2011-002517-11
    Sponsor's Protocol Code Number:CD0001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-01-25
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2011-002517-11
    A.3Full title of the trial
    A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCD0001
    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 SponsorUCB BIOSCIENCES GmbH
    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 supportUCB BIOSCIENCES GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.4Telephone number+492173 48 1515
    B.5.5Fax number+492173481572
    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 nameolokizumab
    D.3.2Product code CDP6038
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNolokizumab
    D.3.9.1CAS number 1007223-17-7
    D.3.9.2Current sponsor codeCDP6038
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe Crohn’s disease
    E.1.1.1Medical condition in easily understood language
    Crohn's disease (an inflammatory disease of the intestines)
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10011403
    E.1.2Term Crohn's disease aggravated
    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 evaluate the proportion of subjects with clinical response (defined as a decrease from Baseline of at least 100 points in the total CDAI score) or in clinical remission (defined as a total CDAI score of ≤150) following 8 weeks of treatment with OKZ, relative to placebo, in subjects with moderate to severe CD.
    E.2.2Secondary objectives of the trial
    To evaluate the number of subjects with clinical response (defined as a decrease from Baseline of at least 100 points in the total CDAI score)
    • To evaluate the number of subjects in clinical remission (defined as a total CDAI score of ≤150)
    • To evaluate changes in CDAI over time
    • To evaluate the safety and tolerability of OKZ therapy
    • To assess the impact of OKZ on subjects’ health-related quality of life as assessed by the IBDQ
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.

    2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake, according to the judgment of the Investigator.

    3. Subject is male or female, 18 to 65 years of age at Screening.

    4. Body mass index between 18 and 35kg/m2.

    5. Diagnosis of CD (colonic localization) confirmed (at least 12 weeks prior to Screening) by either radiological or endoscopic evidence and/or histological examination.

    6. Colonoscopy performed prior to first IMP administration (Week 0) with evidence of active CD and presence of ulceration but with no clinical suspicion of dysplasia or malignancy (colonoscopy to be performed after informed consent has been received, and all other Screening assessments have been completed).

    7. Active inflammation indicated by CRP level ≥ 5mg/L at Screening.

    8. Moderately to severely active CD (CDAI score: 220 to 450, inclusive) at Baseline.

    9. Chest x-ray must have been performed within the last 6 months prior to Screening and must rule out active or old TB infection. Positive radiographic findings consistent with active or old TB infection may include apical lung fibrosis, pleural thickening, calcified lung nodules, calcified hilar lymph nodes, and pericardial calcification. Suspected radiographic findings must be documented with clinical interpretation by the treating physician or medical expert.

    10. Subject must meet all concomitant medication criteria summarized in Table 6:1(page 24 in the protocol) before Baseline (Week 0).

    a) If subjects discontinue the medication prior to Baseline a washout period of at least 2 weeks is required, or longer as detailed in the table.

    b) Corticosteroid equivalent doses are summarized in Appendix 18.1.(see protocol page 65)

    Notes: Nonsteroidal anti-inflammatory drugs and COX inhibitors are prohibited during the study. Low dose
    aspirin (up to 100mg/day) for cardiovascular protection and acetaminophen (as required) are permitted.

    11. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and
    spermicide). Abstinence alone is not an acceptable method. Subjects must agree to use at least 2 forms of adequate contraception during the study and for 6 months (24 weeks) (or longer if required by local regulations) after the last dose of study treatment. Male
    subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 12 weeks (or longer if required by local regulations) after the subject receives the last dose of IMP.
    E.4Principal exclusion criteria
    General Criteria:

    1. Subject has a history of chronic alcohol abuse or drug abuse within the last year.

    2. Subject has any medical or psychiatric condition (according to the Diagnostic and Statistical Manual of Mental Disorders [DSM-IV-TR] criteria) that could jeopardize or would compromise the subject’s ability to participate in this study.

    3. Subject has participated in another study of an IMP, or a medical device, within the last 3 months or 5 half-lives, which ever is longer, or is currently participating in another
    study of an IMP or a medical device.

    4. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 24 weeks following the last dose of the IMP.

    Disease Specific Criteria:

    5. Subject has a diagnosis of ulcerative colitis or indeterminant colitis as determined by the

    6. Subject has obstructive strictures with clinical evidence of partial or completeobstruction.

    7. Subject has an active fistula (fistula secreting spontaneously or by gentle pressure).

    8. In subjects with non-secreting fistula, abscesses need to be ruled out according to local practice (eg, ultrasound, endoscopic ultrasound, or magnetic resonance imaging).

    9. Subject has evidence of an intra-abdominal or peri-rectal infection or abscess.

    10. Subject has a history of diverticulitis or symptomatic diverticulosis.

    11. Subject has had more than one bowel resection, or has had a bowel resection within the 12 months prior to Screening.

    12. Subject has current status or any history of bowel perforation prior to Screening.

    13. Subject has ostomy or ileoanal pouch.

    14. Subject has short bowel syndrome with clinical evidence of malabsorption.

    Prior/Concomitant Medication Criteria:

    15. Subject is currently receiving total parenteral nutrition.

    16. Subject has any prior exposure to natalizumab (Tysabri®).

    17. Subject has any prior exposure to anti-IL-6 agents (eg, TCZ).

    18. Subject is receiving continuous dosing with narcotic analgesics or Vitamin K antagonists (eg, phenprocoumon, acenocoumarol, warfarin).

    19. Subject has had previous exposure to OKZ in a clinical study.

    20. Subject is receiving or has received any live (includes attenuated) vaccination within the 8 weeks prior to Baseline (Week 0) (eg, inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted).

    21. Subject has any condition that requires additional immunosuppressants during the study.

    Laboratory Test Criteria:

    22. Subject has positive stool cultures for enteric pathogens during Screening.
    23. Subject has clinically significant laboratory abnormalities

    Safety Criteria:

    24. Currently known active TB or clinical signs and symptoms consistent with pulmonary or extra-pulmonary TB infection and active TB can not be ruled out at the time of randomization.
    25. Subject has a positive PPD test result at Screening (induration of 5mm or greater), unless the subject has been adequately treated and that there are no residual findings.
    26. Subject receiving concomitant treatment for latent TB during the study.
    27. Subject has concurrent acute or chronic viral hepatitis B or C or known human immunodeficiency virus (HIV) infection.
    28. Subject has a known history of, or current clinically active infection with, Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus.
    29. Subject has a history of chronic or recurrent infections.
    30. Subject has a history of an infected joint prosthesis at any time with that prosthesis still in situ.
    31. Subject has a high risk of infection.
    32. Subject has a history of a lymphoproliferative disorder, including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
    33. Subject has a concurrent malignancy or a history of malignancy.
    34. Subject has Class III or IV congestive heart failure as per the New York Heart Association (NYHA) 1997 criteria.
    35. Subject has a history of, or suspected, demyelinating disease of the central nervous system.
    36. Subject has a transplanted organ (except corneal transplant).
    37. Subject has had major surgery (including joint surgery) within 12 weeks prior to Baseline, or surgery is planned during the study.
    38. Subject has a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, or neurological disease.
    39. Subject has any other condition which, in the Investigator’s judgment, would make the
    subject unsuitable for inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with clinical response (defined as a decrease from Baseline of at least 100 points in the total CDAI score) or in clinical remission (defined as a total CDAI score of ≤150) at Week 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 8.
    E.5.2Secondary end point(s)
    Efficacy end points:
    The proportion of subjects with clinical response (defined as a decrease from Baseline of
    at least 100 points in the total CDAI score) over time
    • The proportion of subjects in clinical remission (defined as a total CDAI score of ≤150) over time
    • Mean change from Baseline in CDAI score over time
    • Mean change from Baseline in IBDQ score over time
    • The proportion of subjects with IBDQ response (defined as an increase in the IBDQ total
    score ≥16 points from Baseline)
    • The proportion of subjects in IBDQ remission (defined as an IBDQ total score ≥170 points)

    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.2
    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 Yes
    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. 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 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 Yes
    E. description
    Olokizumab 120 mg OR 240 mg every two weeks OR 120 mg + loading dose 480 mg at week 0
    E.8.2.4Number of treatment arms in the trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    E.8.7Trial has a data monitoring committee No
    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
    The end of the study is defined as the date of the last visit of the last subject in the study (Safety Follow-Up Visit; Week 18 for subjects completing the study).
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 96
    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)
    Patients of this trial will not be treated different from the expected normal treatment of that condition after the end of the trial.
    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 Decision2012-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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