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    Summary
    EudraCT Number:2018-001060-35
    Sponsor's Protocol Code Number:CLR_18_07
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-21
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-001060-35
    A.3Full title of the trial
    A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term extension study to investigate the safety of Tildrakizumab in patients with Psoricatic Arthritis who have previously completed other studies with Tildrakizumab
    A.4.1Sponsor's protocol code numberCLR_18_07
    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 SponsorSun Pharmaceutical Industries Limited (SPIL)
    B.1.3.4CountryIndia
    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 supportSun Pharmaceutical Industries Limited (SPIL)
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSun Pharma Advanced Research Company Limited
    B.5.2Functional name of contact pointMudgal Kothekar, MD
    B.5.3 Address:
    B.5.3.1Street Address17/B, Mahal Industrial Estate, Andheri East,
    B.5.3.2Town/ cityMumbai
    B.5.3.3Post code400093
    B.5.3.4CountryIndia
    B.5.4Telephone number+91 9632798833
    B.5.6E-mailmudgal.kothekar@sparcmail.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 Yes
    D.2.1.1.1Trade name Ilumetri
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTildrakizumab 100 mg/ml
    D.3.2Product code MK-3222
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNTildrakizumab
    D.3.9.1CAS number 1326244-10-3
    D.3.9.2Current sponsor codeMK-3222
    D.3.9.3Other descriptive nameAnti-Human Interleukin-23 Monoclonal Antibody
    D.3.9.4EV Substance CodeSUB130334
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriatic Arthritis (PsA)
    E.1.1.1Medical condition in easily understood language
    PsA is arthritis associated with psoriasis
    AS and nr-axSpA is a type of chronic inflammatory arthritis involving the spine and/or sacroiliac joints
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety of tildrakizumab when administered to PsA by evaluation of:
    • Incidence and intensity of all AEs,
    • Changes in vital signs, laboratory assessments, electrocardiograms (ECGs), and Columbia-Suicide Severity Rating Scale (C-SSRS),
    • Immunogenicity of multiple-dose administration of tildrakizumab in these subjects.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects may be included in the study if they meet all of the following criteria:
    1. Subject has provided written informed consent for this long-term extension study.
    2. Subjects with PsA who met the inclusion criteria of the parent study and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 study, with return for the EoT assessment at Week 52).
    3. PsA subjects who achieved a 20% reduction from Baseline in American College of Rheumatology (ACR)20 response criteria at Week 52, AND the subject has received sufficient clinical benefit, in the opinion of the Investigator, to support continued treatment with tildrakizumab.
    Note: This criterion using response criteria at Week 52 of the parent study will apply to all subjects, including those subjects who enter the study from the wash-out phase of their parent study (after Week 52) due to the timing of study site activation of the long-term extension study.
    4. No concomitant use of both leflunomide and methotrexate simultaneously.
    5. No history of active tuberculosis (TB) or symptoms of TB.
    E.4Principal exclusion criteria
    Subjects should be excluded from the study if they meet any of the following criteria:
    1. New onset during the parent study of arthritic conditions other than the subject's original condition.
    2. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo-progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 weeks following final administration of IMP.
    3. Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 16 weeks after the last dose of IMP.
    4. Subject has previously been enrolled in this long-term extension study.
    5. Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
    6. Subject has an active infection or history of infections as follows:
    − a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose of the extension study, with the last dose having been received within 7 days of start of the extension study,
    − recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this extension study to be detrimental to the subject.
    7. Major chronic inflammatory or connective tissue disease other than PsA (e.g., rheumatoid arthritis, systemic lupus erythematosus, Lyme disease, gout, Crohn's disease, etc).
    8. Known diagnosis of fibromyalgia, regional pain syndromes or active uveitis/symptomatic inflammatory bowel disease requiring therapy
    9. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject.
    10. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study
    11. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose for this extension study.
    12. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
    13. Subject has a history of malignancy EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.
    14. Subjects with a history of alcohol or drug abuse during the parent study.
    15. Significant risk of suicidality at the Baseline assessment of this extension study based on the Investigator's judgment or, if appropriate, as indicated by a response of "yes" since the last visit to question 4 or 5 in the suicidal section, or any response in the behavioral section of the C-SSRS.
    16. Subject has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP for the long-term extension study.
    17. Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for psoriasis, PsO, and/or PsA
    General
    18. Subjects who have been placed in an institution on official or judicial orders.
    19. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events (AEs)/AEs of special interest (AESI)
    • Laboratory assessments
    • Suicidal ideation and behavior (C-SSRS)
    • Vital signs
    • ECG
    • Physical examination
    • ADA to tildrakizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    • AEs/AESI (Weeks 0, 8, 20, 32, 44, 56, 68, 80, 92, 104, 116, 128, 140, 152, 164, 176, 188, 200 and 208)
    • Laboratory assessments (hematology, chemistry and urinalysis, Weeks 0, 20, 56, 104, 152, 200 and 208 only)
    • Suicidal ideation and behavior (C-SSRS) (all visits except Week 140, 164 and 188)
    • Vital signs (all visits except Week 116, 140, 164 and 188)
    • ECG (annually at Weeks 0, 56, 104, 152, 200 and 208 only)
    • Physical examination (annually at Weeks 0, 56, 104, 152, 200 and 208 only)
    • ADA to tildrakizumab (Weeks 0, 20, 56, 104, 152, 200 and 208 only - Additionally a final ADA sample needs to be collected after 20 weeks from last dose)
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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 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
    Argentina
    Mexico
    United States
    Poland
    Spain
    Hungary
    Russian Federation
    Ukraine
    E.8.7Trial has a data monitoring committee No
    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
    End of study is defined as the last visit of the 4-year treatment period (Week 208, EoT/Follow-up) for the last global subject.
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    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: 248
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 147
    F.4.2.2In the whole clinical trial 286
    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)
    None.
    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 Decision2018-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-18
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