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    Summary
    EudraCT Number:2017-000372-29
    Sponsor's Protocol Code Number:JBT101-SSc-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-000372-29
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
    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 Systemic Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis
    A.4.1Sponsor's protocol code numberJBT101-SSc-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 organisationTMC Pharma Services Ltd
    B.5.2Functional name of contact pointRegulatory Services
    B.5.3 Address:
    B.5.3.1Street AddressLodge Farm Barn, Elvetham Park Estate, Fleet Road
    B.5.3.2Town/ cityHartley Wintney, Hampshire
    B.5.3.3Post codeRG27 8AS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441252842255
    B.5.5Fax number+441252842277
    B.5.6E-mailregulatory.services@tmcpharma.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/3/16/1808
    D.3 Description of the IMP
    D.3.1Product nameLenabasum
    D.3.2Product code JBT-101
    D.3.4Pharmaceutical form Capsule, hard
    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 CodeSUB193005
    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/3/16/1808
    D.3 Description of the IMP
    D.3.1Product nameLenabasum
    D.3.2Product code JBT-101
    D.3.4Pharmaceutical form Capsule, hard
    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 CodeSUB193005
    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, hard
    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
    Systemic Sclerosis (SSc)
    E.1.1.1Medical condition in easily understood language
    A disease of the immune system attacking the connective tissue under the skin and around internal organs and blood vessels causing scarring and thickening of the tissue in these areas.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012977
    E.1.2Term Diffuse systemic sclerosis
    E.1.2System Organ Class 100000004859
    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 compared to placebo in the treatment of SSc by assessing the American College of Rheumatology (ACR) Provisional Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) at Week 52
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing change from Baseline in the modified Rodnan skin score (mRSS) at Week 52.
    2. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the change from Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52.
    3. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the change from Baseline in the forced vital capacity (FVC) % score predicted at Week 52.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A:
    1. Fulfills the 2013 American College of Rheumatology criteria for systemic sclerosis (van den Hoogen et al, 2013).
    2. Diffuse cutaneous SSc (skin thickening on upper arms proximal to the elbows, upper legs proximal to the knees, or trunk).
    3. ≥ 18 years of age at the time Informed Consent is signed.
    4. Written informed consent from the subject.
    5. Disease duration ≤ 6 years from the first non-Raynaud’s symptom. If disease duration is > 3 years and ≤ 6 years, then mRSS ≥ 15. Subjects with disease duration > 3 years and ≤ 6 years and mRSS ≥ 15 will be limited to no more than 1/3rd of the subjects.
    6. Patient Global Assessment ≥ 3 or MDGA ≥ 3.
    7. Stable treatment for SSc ≥ 28 days before Visit 1.
    8. Willing to not start or stop any immunosuppressive medications for SSc from Visit 1 through Visit 11, unless a change is considered in the subject’s best medical interest by the site investigator or another physician who has primary responsibility for treating the subject’s
    SSc.
    9. Willing not to use any cannabinoids including recreational marijuana, medical marijuana and other prescription cannabinoids from Screening through Visit 11.
    10. Women of childbearing potential must not be pregnant or breastfeeding at Screening or 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 product.
    11. Male participants must be willing to follow contraceptive requirements and should not get anyone pregnant while they are taking the study product or within 28 days after taking the last dose of the study product, during which time period they or their partner must be willing to use at least one highly effective method of contraception.
    12. Able to adhere to the study visit schedule and other protocol requirements.
    Part B:
    13. Complete dosing in Part A without permanent discontinuation of
    study product for safety or tolerability reasons or voluntary withdrawal
    from the study.
    14. Complete Visit 11 of Part A.
    15. Understand and voluntarily sign the informed consent.
    16. Able to adhere to the study visit schedule and other protocol
    requirements.
    E.4Principal exclusion criteria
    Part A:
    1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1, such as:
    a. On an organ transplantation list or has received an organ transplant (previous autologous bone marrow/stem cell transplantation is
    permitted, but such cases should be discussed individually with the
    medical monitor).
    b. Renal crisis within 1 year
    c. Interstitial lung disease requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise.
    d. Pulmonary hypertension requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise.
    e. Gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Visit 1.
    2. Certain medications at Screening or Visit 1, including:
    a. Treatment with any oral prednisone > 10 mg per day or equivalent within 28 days before Visit 1. Treatment with intravenous corticosteroids within 28 days before Visit 1 is not allowed, and treatment with intra-articular corticosteroids within 28 days before Visit 1 is allowed (topical corticosteroids are allowed).
    b. New or increase in doses of any non-corticosteroid immunosuppressive medication within 8 weeks before Screening.
    c. Treatment with cyclophosphamide within 3 months before Visit 1.
    3. Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus erythematosus when definite classification criteria for those diseases are met (Bohan and Peter criteria for polymyositis and dermatomyositis [Bohan and Peter, 1975a; Bohan and Peter, 1975b;]; 2010 rheumatoid arthritis classification criteria of ACR/ EULAR [Aletaha, 2010]; ACR revised criteria for the classification of systemic lupus erythematosus [Hochberg,1997]).
    4. SSc-like illnesses related to exposures or ingestions.
    5. A positive test for anti-centromere antibody at Screening. If the subject is anti-centromere antibody positive and clearly has diffuse cutaneous SSC (see inclusion criteria #2), then the subject may be eligible and the investigator must discuss this situation with the Medical monitor to determine eligibility.
    6. Significant diseases or conditions other than SSc that may influence response to the study product or safety, such as:
    a. A new bacterial or viral infection that was treated with oral or intravenous antibiotics or anti-viral treatments within 28 days before Visit 1. This does not include prophylactic antibiotic or anti-viral treatments, or treatment for gastrointestinal bacterial overgrowth.
    b. Acute or chronic hepatitis B or C infection.
    c. Human immunodeficiency virus (HIV) infection.
    d. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment or already completed at least 1 month of ongoing appropriate treatment.
    e. Evidence of required treatment for cancer (except for treated, localized basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) within 3 years of Visit 1.
    7. Any of the following values for laboratory tests at Screening:
    a. A positive pregnancy test in WOCBP (also at Visit 1).
    b. Hemoglobin < 9 g/dL in males and < 8 g/dL in females.
    c. Neutrophils < 1.0 × 1000,000,000/L.
    d. Platelets < 75 × 1000,000,000/L.
    e. Creatinine clearance in blood < 50-mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation. Creatinine clearance may be assessed in a 24 hour urine collection to confirm eligibility (creatinine clearance ≥ 50 ml/min) if screening blood test is < 50 mL/min.
    f. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.
    8. Any investigational agent within 30 days or 5 therapeutic half-lives of that agent whichever is longer, before Visit 1.
    9. Prior exposure to lenabasum.
    10. Significant diseases or conditions other than SSc or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere
    with study assessments.
    Part B:
    11. Patient should be excluded if cause of skin thickening or other
    features attributed to dSSc are now thought to be part of a different
    disease/diagnosis.
    12. Any non-SSc disease or condition, including laboratory or other test
    abnormalities, or non-compliance, that has arisen during Part A that
    would preclude the safe administration of lenabasum in Part B, in the
    opinion of the investigator and/or Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    - Efficacy: American College of Rheumatology (ACR) Provisional
    Combined Response Index in diffuse cutaneous Systemic Sclerosis
    (CRISS) score (lenabasum 20 mg BID)
    - Safety: Treatment Emergent Adverse Events (TEAE) from Day 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 52
    E.5.2Secondary end point(s)
    Efficacy:
    - modified Rodnan skin score (mRSS) (lenabasum 20 mg BID and 5 mg
    BID)
    - Health Assessment Questionnaire-Disability Index (HAQ-DI) score (lenabasum 20 mg BID and 5 mg BID)
    - Forced Vital Capacity (FVC) % predicted (lenabasum 20 mg BID and 5 mg BID)
    - American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score (lenabasum 5 mg BID)
    Safety:
    - Tolerability (percentage of subjects discontinuing study product due to a TEAE probably or definitely related to study product) of lenabasum treatment or placebo treatment
    - Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body temperature, and weight) recorded at each visit (Part A and Part B)
    - Laboratory safety tests obtained at each visit (Part A) and Week 1, Week 4, Week 20, Week 36, Week 52, Week 68, Week 84 and Week 100 (Part B)
    - Complete blood count with cell differential and platelets
    - Metabolic panel that includes renal function, electrolytes, and liver function tests
    - Urine dipstick testing for blood, albumin/protein, and glucose
    - Physical examinations at Day 1, Week 26, and Week 52 (Part A) and each visit (Part B)
    - 12-lead ECGs: at Day1, Week 26, and Week 52 (Part A); Week 12, Week 44, Week 76 and Week 108 (Part B)
    - Late emerging AEs (2-year safety follow-up)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A: Week 52
    Part B: Week 108
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Part B: continuing open label for 2 yrs; 2yr safety follow-up for subjects not continuing to Part B
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Switzerland
    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 years3
    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 years3
    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: 329
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 354
    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 systemic sclerosis (SSc) from their treating physician. Subjects will remain on their baseline treatment for SSc during the trial to reduce the risk of disease flare where study product is discontinued. The Sponsor will offer participation in the continuing Part B open-label trial with lenabasum for subjects who complete Part A through to visit 11 (Day 365/Week 52) or 2-year safety follow-up or subjects discontinuing after Part A.
    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 Decision2018-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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