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    Summary
    EudraCT Number:2019-002717-19
    Sponsor's Protocol Code Number:OLT1177-08
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-12-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-002717-19
    A.3Full title of the trial
    A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare
    A.4.1Sponsor's protocol code numberOLT1177-08
    A.5.4Other Identifiers
    Name:INDNumber:159735
    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 SponsorOlatec Therapeutics LLC
    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 supportOlatec Therapeutics LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOlatec Therapeutics LLC
    B.5.2Functional name of contact pointClinical Trials Inquiries
    B.5.3 Address:
    B.5.3.1Street Address800 Fifth Avenue, Fl 25D
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1833652 8321
    B.5.6E-mailinquiries@olatec.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 nameDapansutrile
    D.3.2Product code OLT1177
    D.3.4Pharmaceutical form Tablet
    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 INNDapansutrile
    D.3.9.1CAS number 54863-37-5
    D.3.9.2Current sponsor codeOLT1177
    D.3.9.3Other descriptive name3-methanesulfonyl-propionitrile
    D.3.9.4EV Substance CodeSUB184700
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboTablet
    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
    Treatment of Acute Gout Flare
    E.1.1.1Medical condition in easily understood language
    Treatment of Acute Gout Flare
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064900
    E.1.2Term Gout flare
    E.1.2System Organ Class 100000004861
    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 dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain at 72 hours post initial loading dose of Investigational Medicinal Product (IMP)
    E.2.2Secondary objectives of the trial
    1. To further assess the clinical activity of dapansutrile compared to placebo in reducing joint pain at scheduled time points post initial loading dose of IMP

    2. To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion)

    3. To assess and compare changes in relevant circulating inflammatory biomarkers between dapansutrile and placebo

    4. To characterize the population pharmacokinetics (PK) of dapansutrile and exposure response relationship for efficacy and safety

    5. To assess the safety and tolerability of dapansutrile compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male and female subjects ≥ 18 years of age
    2) Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria at the Screening/Baseline Visit/Study Day 1
    a. Newly presenting subjects: Diagnosis of gout must be confirmed in the target joint as indicated by either the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint or bursa OR by
    imaging evidence of urate deposition in the target joint or bursa at the Screening/Baseline Visit/Study Day 1
    b. Previously diagnosed subjects: Confirmation of gout diagnosis as per criterion 2a; OR documented history of the presence of MSU crystals in synovial fluid from the target joint or bursa; OR historical imaging report of urate deposition in the target joint or bursa in their medical record
    3) Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening/Baseline Visit/Study Day 1, based on the presence (at the Screening/Baseline Visit/Study Day 1) of subject-reported target joint pain at rest of ≥ 50 mm on a
    0 to 100-mm VAS and at least two of the following criteria in the target joint:
    a. Subject-reported flare
    b. Subject-reported warm joint
    c. Subject-reported swollen joint
    4) Acceptable overall medical condition to safely participate in the study and complete all study procedures (with specific regard to cardiovascular, renal, and hepatic conditions), in the opinion of the Investigator
    5) Able and willing to provide written informed consent prior to initiation of any study related procedures
    6) Ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study, which includes abstaining from the use of Rescue Medication until completion of the first target joint pain assessment on Study Day 4 and abstaining
    from the use of other prohibited medications, including other pain medications
    E.4Principal exclusion criteria
    1) Woman of childbearing potential, or man whose sexual partner(s) is a woman of childbearing potential, who:
    a. Is or intends to become pregnant (including use of fertility drugs) while participating in the study (through the Study Day 36 Follow-up call)
    b. Is lactating/breastfeeding or plans to breastfeed while participating in the study (female subjects only)
    c. Is not willing to use an acceptable, highly effective method of contraception until all follow-up procedures are complete (see Section 4.10.2 for more details on acceptable forms of contraceptives)
    2) Presence of any palpable and visible tophi by physical examination
    3) Has ≥ 4 joints with an acute gout flare at the Screening/Baseline Visit/Study Day 1
    4) Presence of rheumatoid arthritis or other acute inflammatory arthritis
    5) Evidence/suspicion of infectious/septic arthritis
    6) Clinically significant general pain or non-gout-related joint pain that would interfere with the subject’s ability to accurately assess pain in the target joint, in the opinion of the Investigator
    7) Known history of any clinically significant or unstable medical condition or any other disorder, condition, or circumstance (including secondary pain, or recreational or medical use of substances that may alter pain perception such as cannabidiol [CBD]- and
    tetrahydrocannabinol [THC]-containing substances, psilocybin, etc.) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
    8) Any other concomitant medical or psychiatric conditions, diseases, or prior surgeries that, in the opinion of the Investigator, would impair the subject from safely participating in the trial and/or completing protocol requirements6
    9) Use of any prohibited concomitant medications/therapies over the periods defined in Section 4.10.3 or planned use of any prohibited concomitant medications/therapies during the Treatment Period (including the use of paracetamol/acetaminophen within
    4 hours prior to the Screening/Baseline Visit/Study Day 1 or other pain medications within 12 hours prior to the Screening/Baseline Visit/Study Day 1)
    10) Use of any product containing paracetamol/acetaminophen within 4 hours prior to the Screening/Baseline Visit/Study Day 1 or planned use during the Treatment Period (with the exception of study-provided Rescue Medication [paracetamol/acetaminophen],
    which is permitted after completion of the first target joint pain assessment on Study Day 4)
    11) Meets 2 or more of the criteria for substance use disorder provided in Appendix 1 within 1 year of the Screening/Baseline Visit/Study Day 1
    12) History of, or known positive for, human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antibodies to hepatitis C virus (HCV) with a positive polymerase chain reaction (PCR) result for HCV
    13) Known diagnosis of chronic kidney disease or known history of renal impairment (e.g., estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73 m2)
    14) Enrollment in any trial and/or use of any investigational medicinal product or device within the immediate 1-year period prior to the Screening/Baseline Visit/Study Day 1
    15) Enrollment in previous gout studies with dapansutrile
    16) Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, if tested, within 4 weeks of the Screening/Baseline Visit/Day 1
    17) Active malignancy or recent malignancy with any systemic anti-cancer treatment (e.g., immunotherapy or chemotherapy) within the past 6 months
    18) Has a serious illness that resulted in hospitalization in the 30 days preceding the Screening/Baseline Visit/Study Day 1
    19) Has a hypersensitivity or allergy to dapansutrile or other drugs in its class and/or the components of the IMP (dapansutrile tablets or placebo tablets)
    20) Has a hypersensitivity or allergy to paracetamol/acetaminophen
    21) Is an employee, family member, or student of the Investigator or clinical site
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the subject-assessed pain intensity score (100-mm VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 72 hours post initial loading dose
    E.5.2Secondary end point(s)
    Change from baseline in the subject-assessed pain intensity score (100-mm VAS) in the target joint at 12, 24, 36, 48, and 60 hours post initial loading dose, and on Study Day 8 and Study Day 15
    • Subject-assessed PGART on Study Day 8
    • Change from baseline in the Investigator-assessed Target Joint Score (tenderness, swelling, erythema, warmth, and range of motion) at scheduled assessments through Study Day 15
    • Investigator-assessed IGART at scheduled assessments through Study Day 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to protocol end point timepoints
    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 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 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) 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    United States
    France
    Netherlands
    Spain
    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 years0
    E.8.9.1In the Member State concerned months6
    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 months11
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 300
    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 Decision2023-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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