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    Summary
    EudraCT Number:2016-004138-12
    Sponsor's Protocol Code Number:6294-CL-0101
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-13
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2016-004138-12
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis
    Randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze 2a s paralelními skupinami, ověřující koncepci k prozkoumání účinnosti, bezpečnosti, farmakodynamiky a farmakokinetiky přípravku ASP6294 v léčbě pacientek se syndromem bolestivého močového měchýře/intersticiální cystitidou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.
    A.4.1Sponsor's protocol code number6294-CL-0101
    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 SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    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 supportAstellas Pharma Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715455878
    B.5.5Fax number+31715455224
    B.5.6E-mailcontact@nl.astellas.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 nameASP6294
    D.3.4Pharmaceutical form Solution for injection
    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 INNNot applicable
    D.3.9.2Current sponsor codeASP6294
    D.3.9.3Other descriptive nameASP6294
    D.3.9.4EV Substance CodeSUB170581
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
    E.1.1.1Medical condition in easily understood language
    Bladder Pain Syndrome
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071166
    E.1.2Term Bladder pain syndrome
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To investigate efficacy of ASP6294 in female subjects with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC).
    2. To investigate safety and tolerability of ASP6294 in female subjects with BPS/IC.
    3. To investigate the pharmacokinetics and pharmacodynamics of ASP6294 in female subjects with BPS/IC.
    E.2.2Secondary objectives of the trial
    "Not applicable"
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Screening (Visit 1)
    1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is female and at least 18 years of age.
    3. The subject’s signs, symptoms and diagnostic work-up are in accordance with the ESSIC definition for BPS/IC: pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least 1 other urinary symptom such as persistent urge to void or frequency, for at least 6 months in absence of urinary infection or other obvious pathology or identifiable causes. There is documented proof of the diagnosis BPS/IC that has been entered into the subject’s records at least 2 months prior to Visit 1/Screening.
    4. Subject has a score of ≥ 4 and ≤ 9 for pain as assessed by scoring the average pain of the week preceding Visit 1/Screening, using an 11-point NRS (0-10).
    5. Subject has an estimated voiding frequency of ≥ 8 and ≤ 30 voids per 24 hours.
    6. Subject has a score of ≥ 7 on the ICSI questionnaire.
    7. The subject must either:
    Be of nonchildbearing potential:
    - Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or
    - Documented surgically sterile
    Or, if of childbearing potential,
    - Agree not to try to become pregnant during the study and for 5 half-lives after the final study drug administration at Visit 5/Week 8, and
    - Have a negative urine pregnancy test at Visit 1/Screening, and
    - If heterosexually active, agree to consistently use 1 form of highly effective birth control starting at screening and throughout the study period and for 5 half-lives after the final study drug administration at Visit 5/Week 8. Highly effective birth control methods include established use of oral, injected or implanted hormonal methods of contraception, OR placement of an intrauterine device or intrauterine system.
    8. Subjects must agree not to breastfeed starting at screening and throughout the study period, and for 5 half-lives after the final study drug administration at Visit 5/Week 8.
    9. Subject must agree not to donate ova starting at screening and throughout the study period, and for 5 half-lives after the final study drug administration at Visit 5/Week 8.
    10. Subject must be willing and able to comply with study requirements.
    11. Subject agrees not to participate in another interventional study while participating in the present study.
    12. The subject has undergone at least 2 different therapies for BPS/IC with unsatisfactory results, prior to study entry.
    At randomization:
    13. Subject has at least moderate pain as reflected by an average MDP of ≥ 4.0 and ≤ 9.0. The average MDP is the average of daily assessments of MDP in the week prior to the visit with at least 5 recordings. Additionally, the MDP recordings must not differ over 4 points between consecutive days.
    14. Subject has a mean voiding frequency of ≥ 8.0 and ≤ 30.0 per 24 hours as assessed with the 3 day electronic micturition diary in the week prior to the visit.
    15. Subject is confirmed to be willing to comply and has shown to be compliant with all study requirements during the run-in period.
    E.4Principal exclusion criteria
    1.Subject has osteoarthritis or has a history of rapidly progressive osteoarthritis.
    2.Subject has a score of ≥ 30 on the Pain Catastrophizing Scale.
    3.Subject has a score of > 12 on the HADS-D (Hospital Anxiety and Depression Scale - Depression subscale).
    4.Subject has significant pelvic floor pain or spasm which is considered the main cause of the chronic pelvic/bladder pain as concluded by the investigator based on the pelvic floor examination.
    5.Subject has undergone a fulguration or excision of a Hunner’s lesion any time prior to the screening visit.
    6.Subject has recently undergone or started treatment for BPS/IC as specified below:
    -subject has undergone a cystoscopy with hydrodistension or Botox injections in the bladder within 6 months prior to the screening visit.
    -subject has received non-pharmacological interventions for BPS/IC (including but not limited to electric stimulation therapy or acupuncture therapy) within 3 months prior to the screening visit.
    -subject has received any intravesical pharmacological treatment for BPS/IC (including but not limited to heparin or dimethyl sulfoxide) within 4 weeks prior to the screening visit
    -subject had an initiation, discontinuation, or variation in the dose and/or frequency of antimuscarinics, mirabegron, antidepressants (including amitriptyline), anticonvulsants, benzodiazepines, skeletal muscle relaxants, nonsteroidal anti-inflammatory drugs, non opioid analgesics, pentosan polysulphate sodium, homeopathic medication and/or herbal therapies during the last 4 weeks prior to the screening visit.
    -subject has had changes in non-pharmacological treatment for BPS/IC during the last 4 weeks prior to the screening visit.
    7.Subject has bladder pathology as:
    -post-void residual (PVR) >200 mL.
    -known currently symptomatic urethral diverticulum.
    -genital tract condition or pelvic pathology that may complicate diagnosis and the evaluation of pelvic pain and urinary symptoms.
    -known currently symptomatic bladder or ureteral calculi.
    -subject currently has cystitis or has had a documented symptomatic bacterial cystitis within the last 1 month prior to the screening visit. In case of bacterial cystitis (UTI), the subject can be re-screened 1 month after successful treatment.
    -subject has currently clinically significant urinary bladder abnormalities except for abnormalities associated with BPS/IC.
    -subject has had any invasive procedures of either the urinary bladder, urethra, ureter or renal pelvis within 3 months prior to the screening visit.
    -subject has a known current neurologic disease or a defect affecting urinary bladder function.
    -subject has a known current lower urinary tract malignancy.
    8.Subject has a known history of, or currently has inflammatory bowel disease and/or Sjögren Syndrome.
    9.Subject has a known current severe constipation and/or severe diarrhea, severe active diverticulitis and/or severe gastrointestinal bleeding.
    10.Subject has a known or suspected hypersensitivity to ASP6294 or any components of the formulation used.
    11.Subject has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
    12.Subject has a known history of an allergic or anaphylactic reaction to biological drugs.
    13.Subject has received a biological drug during the last 6 months prior to the screening visit.
    14.Subject has a known history of hepatitis B or, C or of human immunodeficiency virus (HIV) infection.
    15.Subject has a known history of or has a currently active or treated sexually transmittable disease.
    17. The subject has peripheral neuropathy, or an abnormality has been observed during the sensory testing at Visit 1/Screening.
    18.Subject has a known currently clinically severe, unstable or uncontrolled renal, hepatic, respiratory, hematological, genitourinary (except BPS/IC), cardiovascular, endocrine, neurological, psychiatric, or other medical illness that, in the opinion of the investigator, may put the subject at safety risk or may mask measures of efficacy.
    19.Subject has had any malignancy diagnosed within 5 years prior to the screening visit, except for curative treated localized non-melanoma skin cancer.
    21.Subject has a body mass index of ≥ 40 kg/m2 as sign of morbid obesity.
    23.Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to the screening visit.
    25.Results of the Visit 1/Screening blood sample indicate that the subject has active hepatic and/or biliary disease, defined as: liver enzymes aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN), or total bilirubin (TBL) > 1.5 times the ULN.
    27.Results of the Visit 1/Screening blood/urine samples indicate that the subject has clinically significant abnormal biochemistry, hematology or urinalysis safety laboratory values other than those mentioned under item 25, as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy
    Change from baseline in average MDP at Visit 6/Week 12.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 6/Week 12
    E.5.2Secondary end point(s)
    Secondary efficacy
    - Change from baseline in average WDP at Visit 6/Week 12.
    - Change from baseline in mean voiding frequency at Visit 6/Week 12.
    - Change from baseline in mean number of level 3 or 4 urgency episodes (using the Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24 hours as assessed with the 3 day electronic micturition diary within the week preceding the study visit, at Visit 6/Week 12.
    - Assessment of the Global Response Assessment (GRA) at Visit 6/Week 12.
    - Change from baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) at Visit 6/Week 12.

    Safety
    - Frequency, nature and severity of Adverse Events (AEs).
    - Laboratory tests: standard hematology, biochemistry, urinalysis, urine culture (if indicated).
    - 12-lead ECG, vital signs measurements, sensory testing and physical examination.

    Pharmacokinetic and Pharmacodynamic
    - Pharmacokinetic: serum level of ASP6294 at all visits.
    - Pharmacodynamic: serum level of total NGF (and possibly other biomarkers) at all visits.

    Other
    - Presence and characteristics of anti-ASP6294 antibodies (ADA) at all visits.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 6/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 No
    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
    - Presence of anti-ASP6294 antibodies (ADA) at Visit 2/Baseline through Visit 7/Week 18.
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Belgium
    Czech Republic
    Germany
    Hungary
    Latvia
    Netherlands
    Poland
    Russian Federation
    Spain
    United Kingdom
    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
    The end of the study is defined as the last visit or follow-up contact of the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 131
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 163
    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)
    Not applicable.
    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 Decision2017-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-21
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