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    Summary
    EudraCT Number:2018-003330-32
    Sponsor's Protocol Code Number:OSCO-P2201
    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:2019-05-06
    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 number2018-003330-32
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Oral SKI-O-703 in Refractory Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberOSCO-P2201
    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 SponsorOscotec Inc.
    B.1.3.4CountryKorea, Republic of
    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 supportOscotec Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOscotec Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressKorea Bio Park, Building A, 9th Floor, 700 Daewangpangyo ro, Bundang gu
    B.5.3.2Town/ citySeongnam si, Gyeonggi do
    B.5.3.3Post code13488
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+820316287661
    B.5.5Fax number+820316287668
    B.5.6E-mailclinical-oct@oscotec.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCevidoplenib
    D.3.2Product code SKI-O-703
    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 INNCevidoplenib
    D.3.9.1CAS number 2043659-93-2
    D.3.9.2Current sponsor codeSKI-O-703
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Rheumatoid Arthritis Despite Treatment With Conventional Therapies
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis despite treatment with conventional therapies
    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 PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 evaluate the efficacy of select (100 mg twice daily [BID], 200 mg BID, and 400 mg BID) doses of SKI-O-703 compared with placebo
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy on other clinical endpoints of select (100 mg BID, 200 mg BID, and 400 mg BID) doses of SKI-O-703 compared with placebo
    To evaluate the safety and tolerability of select (100 mg BID, 200 mg BID, and 400 mg BID) doses of SKI-O-703 compared with placebo
    To investigate the pharmacokinetic (PK) profile of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4)
    To evaluate the effects of SKI-O-703 on exploratory pharmacodynamic (PD) biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is an adult male or female aged ≥18 years old at time of signing the informed consent (or per local customs for ≥19 years of age for Korean subjects).
    2. Subject with Body Mass Index (BMI) of ≥18 and <40 kg/m2 at screening.
    3. Subject who has a diagnosis of RA according to the 1987 ACR criteria (Appendix 13.2) or the 2010 ACR/EULAR classification criteria (Appendix 13.3) for at least 6 months prior to Day 1.
    4. Subject has active disease at screening and baseline following treatment of RA with inadequate response to csDMARDs or anti-TNFα biological agent(s) as per 2012 update of the 2008 ACR RA treatment recommendations.
    a. Active disease is defined as:
    - presence of ≥5 swollen joints and
    - serum hsCRP concentration ≥0.6 mg/dL
    b. At least ONE of the following treatments for RA must have been received: - anti-TNFα biological agent(s): Includes at least 1 of the following treatments, with completed washout period indicated prior to Day 1 dosing
    - csDMARD therapy: Includes at least 1 of the following dosing regimen for at least 90 days of continuous use (prior to Day 1 dosing)*o MTX 15 to 25 mg/week. If the current MTX dose is <15 mg/week, the subject's intolerance to ≥7.5 mg dose must be documented in the subject's medical history
    *Note: Combinations of up to 2 csDMARDs are allowed. However, combination of MTX and leflunomide is not allowed. Subjects are allowed to continue taking csDMARD therapy at stable doses (initiated ≥4 weeks prior to the first dose of study drug) throughout the study period.
    a) If subjects have to discontinue csDMARD therapy (except for leflunomide), the washout windows 30 days prior to Day 1 dosing must be observed
    b) If subjects have to discontinue leflunomide due to combination use with MTX before enrollment, the following washout windows must be observed: subjects who discontinued leflunomide and have had successful chelation with 8 g of cholestyramine (3 times daily) for 3 days must wait for 4 weeks prior Day 1 dosing. Subjects who discontinued leflunomide and did not have cholestyramine washout must wait 12 weeks after last dose of leflunomide prior to Day 1 dosing.
    5. Subject taking MTX while on study must be willing to take dietary supplement of oral folic acid (or equivalent, such as folinic acid) at a stable dose.
    6. Subject who has adequate renal and hepatic function at screening as defined by the following clinical chemistry results:
    a. Serum creatinine <1.5 × ULN or an estimated creatinine clearance level ≤50 mL/min (by MDRD GFR equation)
    b. Serum alanine aminotransferase <2.5 × ULN
    c. Serum aspartate aminotransferase <2.5 × ULN
    d. Serum total bilirubin <2 × ULN
    Repeat of clinical chemistry laboratory tests may be allowed once during screening period (after an approval from medical monitor), if the initial result is unexpected/unexplained (not due to a known underlying condition or concomitant medications or other known cause).
    7. Subject who has the following hematology laboratory test results at screening:
    8. Subject who can comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the Investigator, to understand verbal and/or written instructions, and to comply with the requirements of the entire study.
    9. Subject is informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read or understand this information, signed and dated the written informed consent before inclusion in the study.
    10. A) For both male and female subjects (except subjects in Czech Republic and Repulic of Korea), the subject and their partners of childbearing potential must agree to use one of the following medically acceptable methods of contraception during the study and for 6 months following discontinuation of study drug:
    B) For subjects in Czech Republic and Republic of Korea, both male and female subjects must agree to take the following steps to reduce the potential for the transmission of genetic material containing the investigational product:
    a. Both male and female subjects, the subject and their partners of childbearing potential must agree to use 2 of the following medically acceptable methods of contraception from the time of randomization, during the study, and for 6 months following discontinuation of study drug, of which:
    - One must be a highly reliable method of contraception
    b. Female subjects must agree not to breastfeed starting from the time of screening, throughout the study, and until after 6 months following the last dose of study drug.
    c. Male subjects must agree not to donate sperm starting from the time of randomization, throughout the study, and until after 6 months following the last dose of study drug.
    For subjects and partners considered not of childbearing potential, the following conditions apply
    E.4Principal exclusion criteria
    1. Subject is receiving or has previously received any treatment for RA other than the medications listed in the inclusion criteria for the treatment of RA.
    2. Live or live attenuated vaccine within 4 weeks prior to Day 1 dosing or expected need for live vaccination during study participation including at least 4 weeks after the last dose of study drug.
    3. Subject has had treatment with any other investigational device or medical product within 4 weeks or 5 half-lives prior to Day 1 dosing, whichever is longer.
    4. Subject who (based on the Investigator’s clinical assessment, makes the subject an unsuitable candidate for the study) has any active or recurrent or history of any of the following infections:
    a. Hepatitis B virus (HBV): Serologic evidence of current/previous HBV infection based on the results of testing for hepatitis B surface antigen (HBsAg) and anti-hepatitis B core (anti-HBc) antibody as follows within 6 weeks of Day 1: b. Hepatitis C virus (HCV): Positive test for antibody confirmed on a subsequent blood sample by RNA-polymerase chain reaction (PCR) assay within 6 weeks of Day 1. c. Human immunodeficiency virus (HIV) 1 or 2: Positive test at screening. d. Mycobacterium tuberculosis (TB):
    - For subjects with a history of TB, they may be enrolled if the conditions specified in the protocol met - For subjects with an indeterminate result for interferon-gamma release assay (IGRA) or latent TB (defined as a positive result of IGRA with a negative examination of chest x-ray) at Screening, the conditions specified in the protocol met e. Interstitial pneumonia that is judged by the Investigator/subinvestigator to be inappropriate for the subject to participate in this study. f. Granulomatous infections or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, or invasive fungal infection such as histoplasmosis). A subject who has a past diagnosis with sufficient documentation of complete resolution >6 months prior to Day 1 can be enrolled. g. Chronic or recurrent infection (including herpes zoster) within 6 weeks prior to Day 1. h. Acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to Day 1. i. Other serious infection as assessed by the Investigator within 6 months prior to Day 1.
    5. Subject who has any condition that could confound the evaluation of the data or the effect of the study drug, such as:
    a. Any other inflammatory or rheumatic diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, systemic lupus erythematosus, Lyme disease, or fibromyalgia. Subjects with Sjogren’s disease associated with RA are eligible.
    b. Any conditions significantly affecting the nervous system if it may interfere with the Investigator’s assessment on disease activity scores including joint counts
    c. Severe physical incapacitation, or who cannot benefit from medication
    d. Any other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study
    6. Subject who currently has one or more of the following medical conditions which in the opinion of the Investigator would put the subject at risk by participating in the protocol:
    a. Uncontrolled diabetes mellitus, even after insulin treatment b. Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) c. Clinically significant finding on chest x-ray. Chest x ray must be obtained during the screening period, unless a radiograph was obtained within 12 weeks prior to the screening visit. d. Evidence of cardiac conditions as defined e. Any uncontrolled, clinically significant respiratory disease (in the opinion of the Investigator), including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, or pleural effusion
    7. Subject who has a history of any of the following medical conditions
    a. Any malignancy within the 5 years prior to Day 1 except completely excised and cured squamous cell carcinoma, carcinoma of the cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma. b. Lymphoma or lymphoproliferative disease or bone marrow hyperplasia. c. Organ transplantation, including corneal graft/transplantation. d. Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain-Barré syndrome
    8. Subject who has planned to receive any of the prohibited medications or treatment(s) from the time of informed consent through any additional time periods as indicated
    9. Subject who has clinically significant history of drug or alcohol abuse within the last 6 months.
    10. Female subject who is currently pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP score at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 12
    E.5.2Secondary end point(s)
    Secondary endpoints will be evaluated at Weeks 2, 4, 8 and 12 unless otherwise stated.
    • Percentage of subjects who would achieve ACR20, ACR50 and ACR70 response over time
    • Change from baseline in DAS28-hsCRP score
    • Change from baseline in the tender/painful and swollen joint count (28)
    • Change from baseline in the physician global assessment of disease activity by visual analog scale (VAS)
    • Change from baseline in the subject global assessment of disease activity by VAS
    • Change from baseline in the subject’s assessment of arthritis pain by VAS
    • Change from baseline in the health assessment questionnaire - disability index (HAQ-DI)
    • Change from baseline in median hsCRP values at each visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Weeks 2, 4, 8 and 12 unless otherwise stated
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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 trial4
    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 EEA11
    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
    Czech Republic
    Korea, Republic of
    Poland
    Russian Federation
    Serbia
    Ukraine
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months16
    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.1.2.1Number of subjects for this age range: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 35
    F.4.2.2In the whole clinical trial 148
    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 Decision2019-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-13
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