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    Summary
    EudraCT Number:2010-023047-15
    Sponsor's Protocol Code Number:CC-4047-SSC-001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-14
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-023047-15
    A.3Full title of the trial
    A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease
    A.4.1Sponsor's protocol code numberCC-4047-SSC-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01559129
    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 SponsorCelgene Corporation
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinical Trial Disclosure
    B.5.3 Address:
    B.5.3.1Street Address9900 W. 109th Street, Suite 300, Building 70, Overland Park
    B.5.3.2Town/ cityKansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18882601599
    B.5.5Fax number+19134513459
    B.5.6E-mailClinicalTrialDisclosure@celgene.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/3/12/986
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    D.3.2Product code CC-4047
    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 INNPomalidomide
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 associated with interstitial lung disease
    E.1.1.1Medical condition in easily understood language
    Tissue disease involving changes in the skin, blood vessels and internal organs. It is an'autoimmune disorder', meaning the immune system mistakenly attacks and destroys healthy body tissue.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10025109
    E.1.2Term Lung involvement in systemic sclerosis
    E.1.2System Organ Class 100000004855
    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 safety and tolerability of pomalidomide QD compared to placebo in subjects with SSc-ILD

    To evaluate the change from Baseline (Week 0) in the FVC in SSc-ILD subjects treated with pomalidomide QD compared to placebo

    To evaluate the change from Baseline (Week 0) in the mRSS in SSc-ILD subjects treated with pomalidomide QD compared to placebo

    To evaluate changes from Baseline (Week 0) in GI symptomatology as measured by the UCLA SCTC GIT 2.0 total score in SSc-ILD subjects treated with pomalidomide QD compared to placebo
    E.2.2Secondary objectives of the trial
    To characterize the PK of pomalidomide in subjects with SSc-ILD

    To evaluate the clinical efficacy of pomalidomide QD compared to placebo on dyspnea and oxygen saturation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female subjects between 18 and 80 at the time of signing the ICD
    2.Body weight ≥80pounds (36.3kg) at Screening and Baseline
    3.Understand and voluntarily sign ICDs prior to the initiation of any study-related assessments/procedures
    4.Able to adhere to the study visit schedule and other protocol requirements
    5.Diagnosis of SSc as defined by ACR criteria. Subjects will be further classified into lSSc and dSSc based on the criteria presented in Appendix A
    6.Onset of the first non-Raynaud's manifestation of SSc within 7 years of Screening
    7. Subjects are required to meet at least one of the following 2 pulmonary-related criteria to be eligible for the study:
    -FVC readings ≥ 45% and < 70% at Screening and Baseline (Visit 2) [with or without a documented pre-specified FVC decline or fibrosis score]
    OR
    -FVC readings ≥ 70% and ≤ 80% at Screening and Baseline (Visit 2) with a documented history of either or both of:
    1. A ≥ 5% decrease (expressed as percent predicted or in liters) in FVC in the 24-month period prior to Baseline (Visit 2) based on 3 or more assessments. Two
    assessments may be done during the Screening phase provided the assessments are completed at least 2 weeks apart.
    2. An HRCT fibrosis score > 20%
    8.Repeat FVC at Baseline within 5% of the FVC measured at Screening
    9.DLco ≥ 35% and <or= 80% of predicted value at Screening (Documented DLco assessment within 6 months of Screening is acceptable. Test must be repeated prior to randomization if results are not available).
    10.Abnormalities on HRCT consistent with parenchymal changes encountered in SSc: honeycombing or reticular changes with or without ground glass. These changes are usually symmetrical and are often in subpleural and basal locations. Some involvement of both lungs is required.
    11.Must meet the following laboratory criteria:
    -Hemoglobin ≥10.0 g/dL
    -White blood cell (WBC) count ≥ 3000 /microL (≥ 3.0 x 109/L) and < or=14,000/microL (<or= 14 x 109/L)
    -Absolute neutrophil count (ANC) ≥ 2 x 109/L
    -Platelet count ≥ 150,000 /microL (≥ 150 X 109/L)
    -MDRD eGFR ≥ 60 mL/min
    -Total bilirubin <or= 2.0 mg/dL
    -Albumin ≥ 3.0 g/dL
    -Aspartate transaminase and alanine transaminase ≤ 1.5 X upper limit of normal
    -Negative hepatitis B surface antigen is required. Subjects may have a positive anti-hepatitis B core antibody if the anti-hepatitis B surface antibody is positive as well
    12.Females of childbearing potential must undergo pregnancy testing based on the frequency outlined in Appendix H and pregnancy results must be negative.
    13.Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods as specified in Appendix H.
    -Abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject. Periodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
    14.Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP as specified in Appendix H.
    15.Males must agree not to donate semen or sperm for the duration specified in Appendix H.
    16.All subjects must:
    -Understand that the IP could have a potential teratogenic risk.
    -Agree to abstain from donating blood while taking IP and following discontinuation of investigational product
    -Agree not to share IP with another person.
    -Other than the subject, FCBP and males able to father a child should not handle the IP or touch the capsules, unless gloves are worn.
    -Be counseled about pregnancy precautions and risks of fetal exposure.
    17.Use of the following concomitant medications is permitted. These include:
    -Proton pump inhibitors or other gastroesophageal reflux disease therapies
    -Angiotensin receptor blocker therapies
    -Angiotensin-converting enzyme inhibitor therapies
    -Selective serum reuptake inhibitors
    -Calcium channel blockers
    -Non-sedating oral or intranasal antihistamine agents (intermittent usage)
    -Oral statin agents for hyperlipidemia
    -PDE5 inhibitors (if not being taken for pulmonary arterial hypertension )
    -Endothelin-1 inhibitors (eg, bosentan) or prostaglandin analogues (eg, iloprost) for digital ulcers if taken for at least 28 days (prior to Screening (subjects may not have a diagnosis of PAH requiring treatment)
    -≤ 10 mg/day of oral prednisone (or equivalent)
    -Analgesic or opioid pain medications
    -Cough medications
    -One-a-day vitamins or supplements recommended by the physician for a deficiency are permitted. All others health supplements and herbal remedies are not allowed.
    -Subjects currently taking concomitant medications which can prolong the QT/QTc interval may continue on their medications if their dosage(s) has been stable for at least 28 days prior to Baseline and there is no evidence of pathological QT/QTc prolongation on Screening or Baseline ECGs.
    E.4Principal exclusion criteria
    1.Oxygen saturation<92%(room air [sea level] at rest) at Screening or Baseline
    2.Known diagnosis of obstructive lung disease as defined by FEV1/FVC ratio <0.7
    3.Diagnosis of pulmonary arterial hypertension (PAH) requiring treatment
    4.Known diagnosis of other significant respiratory disorders
    5.Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study
    6. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
    7.Any condition that confounds the ability to interpret data from the study
    8.Pregnant or lactating females
    9.Current clinical diagnosis of another inflammatory connective tissue disease
    10.History of a thromboembolic event
    11.Family history of genetic disease associated with deep vein thrombosis or thromboembolism
    12. History of clinically significant endocrinologic, pulmonary (other thanSSc-related), GI (other than SSc-related), neurologic, psychiatric, hepatic, renal, hematologic, cardiovascular, immunologic or other major uncontrolled disease
    13.History or current diagnosis of peripheral neuropathy
    14.History of alcohol or drug abuse
    15.History of any of the following cardiac conditions within 6 months of Screening: acute myocardial infarction, acute coronary syndrome, new onset atrial fibrillation, new onset atrial flutter, second- or third-degree atrioventricular block, ventricular fibrillation, ventricular tachycardia, heart failure, cardiac surgery, interventional cardiac catheterization (with or without a stent placement), interventional electrophysiology procedure, presence of implanted permanent pacemaker or presence of implanted defibrillator
    16.History of additional risk factors for torsade de pointes
    17.Corrected QTcF>440msec at Screening or Baseline
    18. Presence of any of the following on 2 of the 3 Screening or Baseline
    ECGs (pre-dose) at rest: heart rate<45beats/min or >110beats/min, PR interval>220ms, QRS duration>110ms
    19.Clinically significant abnormality on any Screening or Baseline ECG
    20.History of tuberculosis
    21.History of HIV infection
    22.History of congenital and acquired immunodeficiencies
    23.Hepatitis B surface antigen positive. A positive anti-HBc without a positive anti-HBs at Screening
    24.Antibodies to hepatitis C at Screening
    25.History of malignancy
    26.Use of concomitant medication(s) which could increase the risk for developing deep vein thrombosis
    27.Use of melphalan within 52 weeks of Screening
    28.The addition of concomitant medications associated with QT prolongation during the course of the study
    29.Use of any anti-coagulant or anti-thrombotic medications (other than low dose-aspirin [(<or=100 mg/day). In the event of hospitalization, a subject may use anti-coagulant or anti-thrombotic medications instead of low-dose aspirin, if it is felt to be in the best medical interest of the subject. Aspirin therapy should be reinstituted as soon as the Investigator feels it is medically appropriate.
    30.Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 10 mg/day [mean dose] or equivalent), including but not limited to azathioprine, cyclophosphamide, methotrexate,
    mycophenolate and cyclosporine within 28 days (4 weeks) of Screening
    31.Use of prostaglandin analogues (eg, epoprostenol, iloprost, treprostinil) for PAH within 28 days (4 weeks) of Screening
    32.Use of any biologic agent within 84 days (12 weeks) or 5 half-lives of Screening. In the case of rituximab, use within 168 days (24 weeks) of Screening or no recovery of CD20-positive B lymphocytes if the last dose of rituximab has been more than 168 days (24 weeks) prior to Screening
    33.Use of bosentan, ambrisentan, sildenafil, tadalafil for PAH within 28 days (4 weeks) of Screening
    E.5 End points
    E.5.1Primary end point(s)
    Safety (type, frequency, severity and relationship of AEs to pomalidomide, laboratory, ECG, physical exam or other changes) and tolerability to pomalidomide

    Change from Baseline (Week 0) of the FVC at Week 52

    Change from Baseline (Week 0) of the mRSS score at Week 52

    Change from Baseline (Week 0) of the UCLA SCTC GIT 2.0 total score at Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety:
    - complete physical exam: week 24, week 52, week 56
    - Laboratory: week 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
    - ECG: baseline, week 4, 6, 8, 12, 20, 28, 36, 44, 52 and 56
    - adverse events: everyweek from week 1 to 56
    - survival: every 6 months during the long-term follow-up phase, up to 5 years from treatment initiation.

    FVC: week 52

    mRSS: week 52

    UCLA SCTC GIT: week 52
    E.5.2Secondary end point(s)
    Estimation of pomalidomide PK parameters in plasma, eg, AUCt, Cmax, and tmax (Sparse PK mandatory, Intensive PK only for patients who consent)

    Change from Baseline (Week 0) of the FVC at Weeks 12, 24, 36 and 48

    Change from Baseline (Week 0) of the mRSS at Weeks 12 and 24

    Change from Baseline (Week 0) UCLA SCTC GIT 2.0 total scores at Weeks 12 and 24

    Change from Baseline (Week 0) UCLA SCTC GIT 2.0 subscale scores (Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional Wellbeing and Constipation) at Weeks 12, 24 and 52

    Change from Baseline (Week 0) of the oxygen saturation (as measured by pulse
    oximetry) at Weeks 12, 24 and 52

    Change from Baseline (Week 0) dyspnea (as measured by the Transition Dyspnea Index) at Weeks 12, 24 and 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Sparse PK assessments: weeks 1 to 4, weeks 6 and 8
    Intensive PK assessments: Baseline and week 6

    FVC: Weeks 12, 24, 36 and 48

    mRSS: weeks 12 and 24

    UCLA SCTC GIT: weeks 12, 24, 52

    Oxygen saturation: weeks 12, 24 and 52

    Transition Dyspnea: weeks 12, 24, 52
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 trial2
    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 EEA27
    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
    France
    Germany
    Italy
    Poland
    Russian Federation
    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
    last visit of the last subject at week 56 - end of the Observation Phase
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days7
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-05-14. Yes
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 88
    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)
    Subjects that are still alive will return to their physician to receive standard of care
    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 Decision2012-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-03
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