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    Summary
    EudraCT Number:2021-000859-39
    Sponsor's Protocol Code Number:EP-104IAR-201
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-01
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-000859-39
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients with Osteoarthritis of the Knee
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients with Osteoarthritis of the Knee
    A.4.1Sponsor's protocol code numberEP-104IAR-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04120402
    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 SponsorEupraxia Pharmaceuticals Inc.
    B.1.3.4CountryCanada
    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 supportEupraxia Pharmaceuticals Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNBCD A/S
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressTelefonvej 8D, 2.
    B.5.3.2Town/ citySoborg
    B.5.3.3Post code2860
    B.5.3.4CountryDenmark
    B.5.6E-mailregulatory@nbcd.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.3.2Product code EP-104IAR
    D.3.4Pharmaceutical form Powder and solution for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.2Current sponsor codeEP-104IAR
    D.3.9.3Other descriptive namePVA-coated/cured FP crystals
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoarthritis of the knee
    E.1.1.1Medical condition in easily understood language
    Knee osteoarthritis
    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 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    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 a single intra-articular (IA) injection of EP-104IAR in patients with osteoarthritis (OA) of the knee for up to 24 weeks
    E.2.2Secondary objectives of the trial
    To evaluate the safety of a single IA injection of EP-104IAR in patients with OA of the knee for up to 24 weeks.
    To evaluate the pharmacokinetics (PK) of a single IA injection of EP-104IAR for up to 24 weeks (or 52 weeks for imaging sub-study only).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    optional DCE-MRI sub-study

    Objective (part of secondary objective above): To evaluate the pharmacokinetics (PK) of a single IA injection of EP-104IAR for up to 52 weeks

    optional extended PK sub-study (Denmark only):
    To detect plasma FP concentrations from Week 28 onwards to help refine calculation of the average terminal phase half-life.
    E.3Principal inclusion criteria
    1. Males or females, aged ≥40 years.
    2. Body mass index (BMI) ≤40.0 kg/m2.
    3. Diagnosis of primary OA of the Index knee (as per American College of Rheumatology (ACR) clinical and radiological criteria) with OA symptoms (as reported by the subject) that have been present for at least 6 months prior to Screening.
    4. Index knee OA severity Grade 2 or 3 (based on Kellgren-Lawrence Grading Scale).
    • X-rays will be reviewed by a central reader. If a suitable x-ray performed within 6 months of the Screening Visit cannot be provided, an x-ray must be performed as part of the Screening assessments.
    5. Subject has experienced unsatisfactory pain control from at least 2 prior standard OA treatments, or has used such medications before but chose to discontinue them due to intolerance or personal preference.
    • Standard pharmacological OA treatments include (but are not limited to): Topical or oral NSAIDs, topical capsaicin, IA corticosteroids, IA hyaluronic acid, acetaminophen / paracetamol, duloxetine, tricyclic antidepressants for treatment of pain, tramadol and other opioids.
    • Subjects considered by the Investigator to be non-responsive to treatment with corticosteroids are not eligible.
    6. At Screening Visit 1a, subject reports that their typical OA knee pain in one or both knees when not using medication is ≥4 out of 10.
    7. The weekly WOMAC Pain subscale scores for the Index knee (collected at the end of each week of the Washout and Baseline Period) are both ≥5.0 and ≤9.0 and must not differ (vary) by more than 3 points.
    8. Demonstrated ability to comply with pain recording requirements during the Washout and Baseline Period (i.e., Subject must record daily NPRS scores (of any value) on at least 5 days in each week for both knees and both weekly WOMAC scores in both knees).
    9. The weekly WOMAC Pain subscale scores for the non-Index knee (collected at the end of each week of the Washout and Baseline Period) are both ≤6.0.
    10. Patient is ambulatory (without the need for a cane/other walking aide).
    11. For females of child-bearing potential, willing to use a highly effective method of birth control between Baseline and End-of-Study Visits.
    12. Willing and able to provide informed consent and comply with all study procedures and restrictions and the required visit schedule, etc.
    E.4Principal exclusion criteria
    1.OA of Index knee due to acute injury or trauma that occurred within 12 months prior to Screening, or unstable joint within 12 months of Screening
    2.X-ray evidence of chondrocalcinosis likely to affect outcome of study in opinion of inv.
    3.Diagnosed or suspected IPSI hip OA
    4.Knee pain not clin. attributable to OA of knee
    5.Any other disorders that, in Inv. opinion, impact mobility, strength or sensation, or a co-existent source of pain or inflamm. that interferes with subj ability to assess knee OA pain and function
    6.Presence of other sympt. or cond. in Index knee
    7.History of infec. in Index knee, or clin. signs and sympt. of active infec.
    8.Total/partial KR or other surgery of Index knee
    10.IA injection of CSs in any joint within 3 months prior to Screening, or IA injection of ext-release CSs in any joint
    12.P.o., i.v. or i.m. CSs for any indication within 30 days prior to Baseline; or planned used during study
    13.Inh or In CSc, from start of Washout and Baseline Period until at least 4 Weeks post-dose
    14.Any tp CSs applied to Index knee
    15.Use of long-acting opioids within 30 days prior to Screening, or use of any opioids more than twice per week within 30 days prior to Screening and from which subj. is unwilling or unable to washout
    18.Presence of alcoh. abuse or dependence
    19.Current use of systemic ISx therapy; or use within 6 months prior to Screening
    20.Unwilling or unable to washout of any prohibited meds
    21.Use of another IMP or device within 30 days prior to Screening, or investigational biologic within 60 days prior to Screening, or current/planned participation in other interventional trial during study
    22.History of sarcoidosis or amyloidosis
    23.History of osteomyelitis
    24.History of or active Cushing’s
    25.Currently receiving treatment for following conditions: psychotic disorder, bipolar disorder, symptomatic depressive or anxiety disorders. Mild or well-controlled psych. disorders are permitted if the medication used is not prohibited by protocol
    26.At Screening, a baseline serum cortisol value ≤138 nmol/L (<5 µg/dL) from the ACTH stimulation test or an abnormal ACTH stimulation test result
    27.Currently has diagn. insulin depend. diabetes mellit. or poorly control. non-insulin dependent diabetes mellit. at Screening.
    •Pre-diabetics and well-controlled, non-insulin depend. diabetics are permitted.
    28.Diagnosed hepatic or renal disease
    29.Current malignancy of any type, or history of malignancy within 12 month prior to Screening
    30.Any infec. requiring IV antibiotics within 4 weeks of the Baseline Visit, or oral ABX within 2 weeks of the Baseline Visit
    31.Known active or quiescent systemic fungal, bacterial viral or parasitic infec., or ocular herpes simplex
    32.Known or clinically suspected infec. with HIV, hepatitis B or C viruses
    33.Skin breakdown on Index knee
    34.Females who are pregnant, lactating, or who have positive pregnancy test at Screening or Baseline Visits
    35.Known or suspected hypersensitivity or contraindication to any ingredients in IMP, to FP or any other corticosteroids, or lidocaine.
    37.Previous RND and TRT in this study
    38.Any other reason that, in opinion of INV, is likely to unfavorably alter subject risk-benefit, confound safety or efficacy results, or make it difficult for the subject to fully comply with study requirem.

    Additional ex criteria for the optional MRI Sub-Study
    Subj. who are willing to participate in imaging sub-study are also subject to following ex criteria. If a subject meets any of these criteria it only invalidates their participation in the MRI sub-study:
    39.Unwilling and/or unable to provide IC and comply with all MRI sub-study procedures and restrictions and the required visit schedule
    40.Known allergy or a prior AR to gadolinium or to any of the excipients contained in the MRI contrast agent
    41.History of severe allergy, drug reactions, or other hypersensitivity-like disorders and bronchial asthma
    42.Any metal objects e.g., shrapnel, and any surgical clips, pacemakers, pins, plates, screws, metal sutures or wire mesh also including uterine coil, intra-ocular metal foreign bodies, new contact lens that allows for an automated recording of continuous intraocular pressures, the LINX reflux management system insulin pump, temporary ext. TVP leads, if considered CI for MRI scanning
    43.Severe claustrophobia
    44.Cochlear implants
    45.Known renal conditions, for which contrast agents for MRI could add to risks, or moderate to severe renal dysfunction (defined as an estimated eGFR ≤ 40 mL/min/1.73m2 by laboratory testing and the [CKD-EPI] equation)
    46.Females who are pregnant, lactating, or who have a positive pregnancy test result prior to any planned MRI procedure.

    Additional ex. criteria for the PK Sub-Study
    47.Unwilling and/or unable to provide IC for the PK sub-study.
    48.Currently using any products containing FP, or use of products containing FP within 7 days prior to the unscheduled PK visit.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in change from baseline (CFB) between EP-104IAR and vehicle in WOMAC Pain at Week 12, in the intention-to-treat (ITT) population
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    1) Difference in CFB between EP-104IAR and vehicle in WOMAC Function at Week 12
    2) Difference between EP-104IAR and vehicle in the area under the curve of WOMAC Pain at Week 12
    3) Difference in CFB between EP-104IAR and vehicle in WOMAC Pain at Week 24
    4) Difference between EP-104IAR and vehicle in OMERACT OARSI strict responders at Week 12 (OMERACT-OARSI=Outcome Measures in Rheumatology-Osteoarthritis Research Society International)

    Additional secondary and exploratory safety, PK and imaging endpoints are discussed in detail in Section 11 of the protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 12
    2) Week 12
    3) Week 24
    4) Week 12
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    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)
    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 Decision2021-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-06
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