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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-010714-30
    Sponsor's Protocol Code Number:1275148SCD2001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-20
    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 ConcernedUK - MHRA
    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.4.1Sponsor's protocol code number1275148SCD2001
    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 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 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 nameGolimumab Liquid in prefilled syringe
    D.3.2Product code CNTO 148
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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 No
    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 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 Information not present in EudraCT
    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) 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 No
    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 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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039486
    E.1.2Term Sarcoidosis
    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
    1. Male or female ≥18 to ≤ 85 years of age

    2. Have histologically proven sarcoidosis with an onset date of ≥ 2 years prior to screening with at least 1 of the following:
    a. pulmonary sarcoidosis defined as requiring:
    1) A diagnosis of sarcoidosis with evidence of lung parenchymal disease (Stage II, III or IV on chest radiograph). For subjects with Stage IV sarcoidosis, the chest radiograph should be interpreted as having interstitial infiltrates without cavitating disease, AND
    2) a FVC of ≥45% and ≤ 80% of the 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 the baseline visit relative to the screening visit
    AND/OR
    b. skin sarcoidosis defined as requiring:
    1) active chronic skin lesions for ≥3 months either on the face (eg, lupus pernio) or elsewhere on the body (typically indurated lesions consisting of papules, nodules and/or plaques) that have not resolved on current systemic and/or local therapy (ie, intralesional injections). Subjects, excluding those with only lupus pernio facial lesions confirmed by a dermatologist, will be required to have a skin biopsy, performed at screening or between the screening and baseline (Week 0) visit, which is diagnostic of sarcoidosis, 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 (with an induration subscore ≥1) at screening

    3. Have been receiving treatment with oral corticosteroids (≥10 mg/day of prednisone or equivalent dose of corticosteroid) and/or 1 or more immunomodulators (eg, methotrexate, AZA, chloroquine, hydroxychloroquine, mycophenolate, or leflutamide) for ≥3-month period immediately prior to screening. Subjects must be on a stable dose of these medications for ≥4 weeks before screening. For those subjects taking OCS, the dose at the screening visit must be ≤ 25 mg of prednisone (or equivalent dose of corticosteroid).

    4. Women of childbearing potential and men must be using adequate birth control measures (abstinence, hormonal contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue such precautions, and not become pregnant or plan a pregnancy for 6 months after receiving their last treatment with study agent. Women of childbearing potential must test negative on a serum pregnancy test at screening.

    5. Are considered eligible according to the following tuberculosis (TB) screening criteria:
    a. Have no history of latent or active TB prior to screening.
    b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    c. Have had no recent close contact with a person with active TB.
    d. Within 2 months prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result
    e. Have a chest radiograph (both posterior-anterior and lateral views), taken within 2 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.

    6. The investigator has discussed with the subject the information contained within the informed consent regarding anti-TNFα and anti IL-12/23 therapies and the potential risk of cancer, and has reviewed with the subject country-specific guidance (local practice) on cancer screening and the impact of life-style choices (eg, smoking) on the risk of developing cancer.

    7. Are capable of reading and understanding subject assessment forms and providing written informed consent.

    8. Are willing and able to adhere to the study visit schedule and other protocol specified procedures.
    E.4Principal exclusion criteria
    1. Have a diagnosis of other significant respiratory disorder other than sarcoidosis that in the opinion of the investigator would complicate the evaluation of response to treatment.
    2. Have a smoking history of ≥ 20 pack years.
    3. Have used any investigational drug within 1 month prior to screening or within 5 half lives of the investigational agent, whichever is longer.
    4. Have received previous administration of a treatment with any other therapeutic agent targeted at reducing TNFα (eg, pentoxifylline, thalidomide, etanercept, adalimumab, certolizumab, infliximab, golimumab) or anakinra within 6 months or 5 half lives of the agent, whichever is longer, prior to the screening visit. Subjects who have previously received biologic anti TNFα agents outside of the above period are allowed to enter the study; however, their prior history of usage of biologic anti TNFα agents (type, dosage, response to treatment, and reason for cessation of treatment) should be recorded.
    5. Have previously used cyclophosphamide.
    6. 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.
    7. Have used any therapeutic agent targeted at reducing IL 12 and/or IL 23, including but not limited to, ustekinumab and ABT 874 within 6 months or 5 half lives of the agent, whichever is longer, prior to the screening visit.
    8. Have received natalizumab or agents that deplete or modulate the activity of B cells or T cells (eg, rituximab, alemtuzumab, efalizumab, or visilizumab) within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population.
    9. Have used any antibody (monoclonal or polyclonal) or antibody based (antibody fragment, etc.) agents ≤ 6 months or within 5 half lives of the biologic prior to the screening visit, whichever is longer.
    10 Have had any previous adverse reactions or allergic reactions (eg, anaphylaxis) associated with the administration of monoclonal antibodies or antibody fragments.
    11. Have experienced an anaphylactic reaction to latex.
    12. Have known clinically significant pulmonary hypertension and are receiving vasodilator therapy (eg, calcium channel blockers, prostacyclin or prostacyclin analogs, nitric oxide, adenosine).
    13. Have participated in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to the screening visit or plan to participate in pulmonary rehabilitation during the study.
    14. Have concomitant diagnosis or any history of CHF, including medically controlled CHF, severe right-sided heart failure (ie cor pulmonale).
    15. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral disease or any laboratory abnormality which would pose/suggest a risk to the subject during participation in the study. Subjects with sarcoid involvement as the cause of dysfunction in these organs will be permitted to be enrolled.
    16. Have current signs or symptoms of infection or history of serious infection (eg, sepsis, pneumonia, or pyelonephritis), including any infection requiring hospitalization or IV antibiotics, for 3 months prior to screening. Established nonserious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.
    17. Have had chronic or recurrent infectious disease, including, but not limited to: lung infection (eg, lung abscess); renal infection (eg, recurrent pyelonephritis); urinary tract infection (other than simple, recurrent cystitis); or skin wound or ulcer.
    18. Are known to be infected with HIV.
    19. Are known to be infected with hepatitis B virus (HBV) or hepatitis C virus (HCV) or have other chronic liver diseases other than sarcoidosis involving the liver.
    19_1. Test positive for HBV infection at screening.
    20. Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening. Have signs and symptoms or a history of latent or active granulomatous infection (including TB or aspergilloma).
    21. Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to screening.
    22. Have evidence of a herpes zoster infection ≤ 8 weeks prior to screening.
    23. Have history of known demyelinating diseases, such as multiple sclerosis.
    24. Have a chest radiograph within 2 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB and/or cavitating disease.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline in percent predicted FVC at Week 16 in the primary population. Two populations (primary and secondary populations) are considered for analysis. These 2 populations comprise 3 strata:
    Stratum 1: Subjects with pulmonary involvement that fulfill the eligibility criteria for the primary population, but without skin involvement that fulfill the eligibility criteria for the secondary population,
    Stratum 2: Subjects with skin involvement that fulfill the eligibility criteria for the secondary population, but without pulmonary involvement that fulfill the eligibility criteria for the primary population, and
    Stratum 3: Subjects with both pulmonary and skin involvement that fulfill the eligibility criteria for both the primary and secondary populations.
    The primary population will have ≥135 subjects and contain Stratum 1 and Stratum 3. The secondary population will have ≥45 subjects and contain Stratum 2 and Stratum 3. The secondary population may contain subjects with pulmonary involvement not meeting the criteria for primary population. Similarly, the primary population may contain subjects with skin involvement not meeting the criteria for the secondary population
    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.8.3 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 concerned8
    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 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 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 months2
    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 months2
    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.1.3Elderly (>=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 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 state10
    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 Decision2009-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-17
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