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    Summary
    EudraCT Number:2017-003723-29
    Sponsor's Protocol Code Number:JBT101-CF-002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-05-08
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2017-003723-29
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
    Многоцентрово, рандомизирано, двойно-сляпо, плацебо-контролирано, фаза 2 изпитване за оценка на ефикасността и безопасността на Lenabasum при кистична фиброза
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of safety and efficacy of lenabasum in Cystic Fibrosis
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis
    A.4.1Sponsor's protocol code numberJBT101-CF-002
    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 SponsorCorbus Pharmaceuticals, 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 supportCorbus Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services Ltd
    B.5.2Functional name of contact pointRegulatory Unit
    B.5.3 Address:
    B.5.3.1Street Address103 Haros Str
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1222
    B.5.3.4CountryHungary
    B.5.4Telephone number+361299 00 91
    B.5.5Fax number+361299 00 96
    B.5.6E-mailregulatory@accelsiors.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1736
    D.3 Description of the IMP
    D.3.1Product nameLenabasum
    D.3.2Product code JBT-101
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLenabasum
    D.3.9.1CAS number 137945-48-3
    D.3.9.2Current sponsor codeJBT-101
    D.3.9.3Other descriptive nameresunab, ajulemic acid, anabasum
    D.3.9.4EV Substance CodeSUB178399
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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 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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1736
    D.3 Description of the IMP
    D.3.1Product nameLenabasum
    D.3.2Product code JBT-101
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLenabasum
    D.3.9.1CAS number 137945-48-3
    D.3.9.2Current sponsor codeJBT-101
    D.3.9.3Other descriptive nameresunab, ajulemic acid, anabasum
    D.3.9.4EV Substance CodeSUB178399
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 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 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
    Cystic Fibrosis (CF)
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of lenabasum 20 mg twice per day (BID) compared to placebo in the treatment of cystic fibrosis (CF) by assessing the rate of pulmonary exacerbations (PEx) using primary definition of PEx
    E.2.2Secondary objectives of the trial
    Efficacy:
    1. To evaluate the efficacy of lenabasum 20 mg BID compared to placebo in the treatment of CF by assessing other efficacy endpoints
    2. To evaluate the efficacy of lenabasum 5 mg BID compared to placebo in the treatment of CF
    Pharmacokinetic:
    1. To evaluate steady state plasma concentrations of
    lenabasum 20 mg and 5 mg BID at the estimated time of trough
    concentration after a dose of lenabasum
    2. To evaluate plasma concentrations of lenabasum 20 mg and 5 mg at
    the estimated time of peak concentration after the first dose
    3. To evaluate metabolites of lenabasum
    4. To develop population pharmacokinetic models of lenabasum
    exposure in CF subjects
    Safety:
    1. To evaluate safety of lenabasum 20 mg BID and lenabasum 5 mg BID
    treatment and placebo treatment
    2. To evaluate tolerability of lenabasum 20 mg BID and lenabasum 5 mg BID treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
    a. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test
    b. Two known disease-causing mutations in the CFTR gene.
    2. Twelve years of age or older at the time Informed Consent/Assent is signed.
    3. Weight ≥ 40 kg.
    4. FEV1 ≥ 40% predicted and < 100 % predicted within the last 12 months.
    5. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx.
    6. As an alternative to inclusion criterion 5, physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEx.
    7. Completion of the last course of antibiotics prescribed for any PEx ≥ 28 days before Visit 1.
    8. Able to perform pulmonary function tests. Optional use of a bronchodilator before testing is allowed to facilitate testing if the bronchodilator is used consistently starting with Visit 1.
    9. Willing to provide repeat sputum specimens. If a subject is unable to reliably spontaneously expectorate sputum, induced sputum collection is acceptable. Optional collection of induced sputum specimens is allowed if induced sputum specimens are consistently collected starting with Visit 1. Adolescents should try to produce sputum spontaneously and can opt out of sputum induction.
    10. Willing not to use any cannabinoids or any illegal substance of abuse from screening through Visit 9.
    11. Women of childbearing potential must not be pregnant or breastfeeding at Visit 1 and must be using at least one highly effective method of contraception (failure rate < 1% per year) for at least 28 days before Visit 1 and be willing to continue to use at least one highly effective method of contraception throughout the study and for at least 28 days after discontinuation of study drug .
    12. Able to adhere to the study visit schedule and other protocol requirements.
    E.4Principal exclusion criteria
    1. Severe or unstable CF at screening or Visit 1, such as:
    a. Change in dose, or initiation of any new chronic therapy for CF lung disease within 28 days before Visit 1
    b. Treatment with any systemic corticosteroids > 10 mg per day prednisone or equivalent within 14 days before Visit 1
    c. Actively listed on an organ transplant list or have had an organ transplant other than corneal transplant.
    2. Significant diseases or conditions other than CF that may influence response to the study drug or safety, such as:
    a. Active hepatitis B or C infection
    b. Human immunodeficiency virus infection
    c. A history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ one year before Visit 1.
    3. Pregnant, trying to become pregnant or lactating female.
    4. Current evidence of alcohol abuse (defined as 4 or more drinks per day on at least 4 days of the week) or history of abuse of illegal and/or legally prescribed drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, or opioids during the 1 year before screening.
    5. Any investigational agent within 30 days or five therapeutic half-lives of that agent whichever is longer, before Visit 1
    6. Any of the following values for laboratory tests at screening:
    a. A positive pregnancy test
    b. Hemoglobin < 10 g/dL in males and < 9 g/dL in females.
    c. Neutrophils < 1.0 x 1000,000,000/L
    d. Platelets < 75 x 1000,000,000/L
    e. Creatinine clearance < 50 ml/min according to Modification of Diet in Renal Disease (MDRD) Study equation
    f. Serum transaminases > 2.5 x upper normal limit
    7. Any other condition or concurrent medical therapy at screening or Visit 1 that causes the investigator to determine it is not safe for the subject to participate or that may influence response to study drug or interfere with study assessments.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of PEx using primary definition of PEx with lenabasum 20 mg BID, compared to placebo, during the treatment period
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 through study completion, up to 6 months
    E.5.2Secondary end point(s)
    Efficacy (lenabasum 20 mg BID):
    a. Event rate of PEx using secondary definition of PEx with lenabasum 20 mg BID compared to placebo
    b. Time to first new PEx using primary definition of PEx with lenabasum 20 mg BID compared to placebo
    c. Time to first PEx using secondary definition of PEx with lenabasum 20 mg BID compared to placebo
    d. Change from baseline in CFQ-R respiratory symptom domain with lenabasum 20 mg BID compared to placebo
    e. Change from baseline in FEV1 % predicted with lenabasum 20 mg BID compared to placebo
    Efficacy (lenabasum 5 mg BID):
    a. Rate of pulmonary exacerbations (PEx) using primary definition of PEx with lenabasum 5 mg BID compared to placebo, during the treatment period
    b. Event rate of PEx using secondary definition of PEx with lenabasum 5 mg BID compared to placebo
    c. Time to first new PEx using primary definition of PEx with lenabasum 5 mg BID compared to placebo
    d. Time to first PEx using secondary definition of PEx with lenabasum 5 mg BID compared to placebo
    e. Change from baseline in CFQ-R respiratory symptom domain with lenabasum 5 mg BID compared to placebo
    f. Change from baseline in FEV1 % predicted with lenabasum 5 mg BID compared to placebo
    Pharmacokinetics:
    1. Estimated trough plasma concentrations of lenabasum
    2. Estimated maximum plasma concentration (Cmax) of lenabasum
    3. Metabolites of lenabasum
    Safety:
    1. Treatment emergent adverse events (TEAEs)
    2. Changes in vital signs, physical examination, blood and urine
    laboratory safety tests and electrocardiograms
    3. Treatment discontinuations with lenabasum treatments compared to
    placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy and Safety endpoints: Visit 1 through study completion, up to 6 months;
    PK endpoints: Visit 1 through Visit 8.
    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 No
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Réunion
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 62
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 62
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 353
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 415
    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)
    After the trial, subjects will continue to receive care for cystic fibrosis from their treating physician. Subjects will remain on their baseline treatment for cystic fibrosis during the trial to reduce the risk of disease flare where study product is discontinued.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Cystic Fibrosis Society (ECFS) - Clinical Trial Network
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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