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    Summary
    EudraCT Number:2009-010714-30
    Sponsor's Protocol Code Number:1275148SCD2001
    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:2009-08-17
    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 number2009-010714-30
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients with Sarcoidosis
    A.4.1Sponsor's protocol code number1275148SCD2001
    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 SponsorJanssen Biologics B.V.
    B.1.3.4CountryNetherlands
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group, Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310715252166
    B.5.5Fax number310715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameGolimumab Liquid in prefilled syringe
    D.3.2Product code CNTO 148
    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 INNgolimumab
    D.3.9.2Current sponsor codeCNTO 148
    D.3.9.3Other descriptive namehuman anti TNF-alpha monoclonal antibody
    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.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) 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.IMP: 2
    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 nameustekinumab liquid in prefilled syringe
    D.3.2Product code CNTO1275
    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 INNustekinumab
    D.3.9.2Current sponsor codeCNTO 1275
    D.3.9.3Other descriptive namehuman anti-IL 12/23 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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) 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    Chronic sarcoidosis
    E.1.1.1Medical condition in easily understood language
    Chronic sarcoidosis
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10039486
    E.1.2Term Sarcoidosis
    E.1.2System Organ Class 10021428 - Immune system 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 is to evaluate the safety and efficacy of treatment with ustekinumab or golimumab in subjects with chronic sarcoidosis with pulmonary involvement despite current therapy.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety of ustekinumab or golimumab in subjects with chronic sarcoidosis with pulmonary and/or skin involvement
    2. To evaluate the efficacy of ustekinumab or golimumab in improving the symptoms, functional capacity, and patient reported outcomes at Week 28 in subjects with chronic pulmonary sarcoidosis who are symptomatic despite current treatment
    3. To evaluate the efficacy of ustekinumab or golimumab in improving the symptoms and patient reported outcomes at Week 28 in subjects with skin manifestations of chronic sarcoidosis who are symptomatic despite current treatment
    4. To assess the ability to taper off of OCS in subjects with chronic pulmonary and/or skin sarcoidosis who are symptomatic despite current OCS treatment
    5. To assess the pharmacodynamics (PD) and pharmacokinetics (PK) of ustekinumab or golimumab in subjects with chronic sarcoidosis with pulmonary and/or skin involvement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must have sarcoidosis with onset date of >=2 years prior to screening with at least 1 of the following: a. pulmonary sarcoidosis defined as 1) a diagnosis of sarcoidosis with evidence of lung parenchymal disease (Stage II, III or IV on chest radiograph), and 2) an FVC of >=45% and <=80% of predicted normal value at screening, and 3) an MRC dyspnea score of >2 at screening, and 4) a 6 minute walk distance between 100 to 550 meters at screening, and 5) <=15% absolute change in percent-predicted FVC at baseline relative to screening AND/OR b. skin sarcoidosis defined as 1) active chronic skin lesions for >=3 months either on face or elsewhere on body that have not resolved on current systemic and/or local therapy, and 2) have either: a single lesion of >=2 cm in longest dimension or multiple (3 or more) lesions with at least 1 lesion having a longest dimension of >=1 cm, and 3) have an SPGA score >=2 at screening - have been receiving treatment with oral corticosteroids and/or 1 or more immunomodulators for >=3-month period immediately prior to screening - on a stable dose of thesemedications for >=4 weeks before screening
    E.4Principal exclusion criteria
    Have a diagnosis of other significant respiratory disorder other than sarcoidosis that would complicate the evaluation of response to treatment - Have a smoking history of >=20 pack years - Have used an investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer - have received previous administration of a treatment with any other therapeutic agent targeted at reducing TNFalpha within 6 months or 5 half-lives of the agent, whichever is longer, prior to screening - Patients who have previously received biologic anti-TNFalpha agents outside of the above period are allowed to enter the study - Have previously used cyclophosphamide - Have previously used or received local therapy (including local injections) within 3 months before the screening visit or used or received treatment with prescription topical creams within 1 month before the screening visit for treatment of sarcoidosis skin lesions - Have used any therapeutic agent targeted at reducing IL-12 and/or IL-23, including but not limited to, ustekinumab and briakinumab within 6 months or 5 half-lives of the agent, whichever is longer, prior to the screening visit - have received natalizumab or agents that deplete or modulate the activity of B cells or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population - have used any antibody (monoclonal or polyclonal) or antibody-based agents <= 6 months or within 5 half-lives of the biologic prior to the screening visit, whichever is longer
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline in percent-predicted Forced Vital Capacity (measure of lung volume at maximum rate of exhalation) at Week 16 in the primary population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    E.5.2Secondary end point(s)
    Change from baseline in 6 minute walk distance at Week 28 in the primary population

    Change from baseline in St. George's Respiratory Questionnaire total score at Week 28 in the primary population

    Proportion of Skin Physician Global Assessment responders at Week 28 in the secondary population

    Change from baseline in percent-predicted Forced Vital Capacity at Week 28 in the primary population.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 28
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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.8.2.4Number of treatment arms in the trial3
    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 EEA40
    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
    Denmark
    France
    Germany
    Italy
    Netherlands
    Romania
    United Kingdom
    United States
    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 patient last visit.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 180
    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)
    This information has been provided in the protocol.
    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 Decision2009-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-17
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