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

At Screening (Visit 1)
* The subject is female and at least 18 years of age.
* 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 one 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.
The subject has undergone at least two different therapies for BPS/IC with unsatisfactory results, prior to study entry.
* 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.
* The 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).
* The subject has an estimated voiding frequency of * 8 and * 30 voids per 24 hours.
* The subject has a score of * 7 on the ICSI questionnaire
* The subject must agree not to breastfeed starting at screening and throughout the study period, and for 5 half-lives (i.e., 70 days) after the final study drug administration at Visit 5/Week 8.
* The subject must agree not donate ova starting at screening and throughout the study period, and for 5 half-lives (i.e., 70 days) after the final study drug administration at Visit 5/Week 8.
* The subject must be willing and able to comply with study requirements (e.g., complete questionnaires and diaries, able to read and attend all required study visits).
* The subject agrees not to participate in another interventional study while participating in the present study (i.e., between Visit 1/Screening and Visit 7/Week 18).;At randomization (Visit 2/Baseline)
* The 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.
* The subject has a mean voiding frequency of * 8.0 and * 30.0 per 24 hours as assessed with the 3day electronic micturition diary in the week prior to the visit.
* The subject is confirmed to be willing to comply and has shown to be compliant with all study requirements during the run-in period.

At Screening (Visit 1)
* The subject has osteoarthritis or has a history of rapidly progressive osteoarthritis.
* The subject has a score of * 30 on the Pain Catastrophizing Scale (PCS).
* The subject has a score of > 12 on the HADS-D (Hospital Anxiety and Depression Scale - Depression subscale).
* The 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.
* The subject has undergone a fulguration or excision of a Hunner*s lesion any time prior to the screening visit.
* The 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 (e.g., diet or physical therapy) during the last 4 weeks prior to the screening visit.
* The subject has bladder pathology as specified below:
* a post-void residual (PVR) >200 mL.
* subject has a known currently symptomatic urethral diverticulum.
* subject has genital tract condition or pelvic pathology (e.g., post-partum, post-pelvic surgery, post-hysterectomy) that may complicate diagnosis and the evaluation of pelvic pain and urinary symptoms. Note: A history of a Cesarean section is not a reason for exclusion.
* subject has a known currently symptomatic bladder or ureteral calculi.
* subject currently has cystitis (radiation cystitis, Bacillus Calmette-Guérin-induced cystitis, bacterial/tuberculous cystitis, cyclophosphamide 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 (e.g., bladder mass, bladder stone, bladder diverticulum, small contracted end-stage bladder), except for abnormalities associated with BPS/IC.
* subject has had any invasive procedures of either the urinary bladder, urethra, ureter or renal pelvis (e.g., transurethral resection of bladder [including bladder biopsy], urethral dilatation, endovesicular lithotripsy) within 3 months prior to the screening visit.
* subject has a known current neurologic disease or a defect affecting urinary bladder function (e.g., neurogenic bladder, systemic or central neurological disease, such as Multiple Sclerosis or Parkinson*s disease).
* subject has a known current lower urinary tract malignancy.
* In case of positive sediment (micro) hematuria results, local procedures/guidelines will need to be followed to exclude malignancy. Only if hematuria has been present within the last 6 months and malignancy has been adequately ruled out by the investigator according to local diagnostic procedures, the subject does not have to be excluded. Note that if the subject had a (negative) bladder biopsy, the subject can only be re-screened after 3 months following this biopsy. Documentation of all diagnostic outcomes and investigator*s decisions need to be available.
* The subject has a known history of, or currently has inflammatory bowel disease (i.e., Crohn*s Disease or Ulcerative Colitis) and/or Sjögren Syndrome.*
* The subject has a known current severe constipation and/or severe diarrhea, severe active diverticulitis and/or severe gastrointestinal bleeding.
* The subject has a known or suspected hypersensitivity to ASP6294 or any components of the formulation used.
* The subject has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
* The subject has a known history of an allergic or anaphylactic reaction to biological drugs (e.g., [monoclonal] antibodies including tanezumab or fusion proteins).
* The subject has received a biological drug (e.g. [monoclonal] antibodies including tanezumab or fusion proteins) during the last 6 months prior to the screening visit.
* The subject has a known history of hepatitis B or C or human immunodeficiency virus (HIV) infection.
* The subject has a known history of or has a currently active or treated sexually transmittable disease (including genital herpes).
* The subject has a known current substance abuse issue (including alcoholism), as perceived by the investigator.
*The subject has peripheral neuropathy, or an abnormality has been observed during the sensory testing at Visit 1/Screening
.* The 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.
* The subject has had any malignancy diagnosed within 5 years prior to the screening visit, except for curative treated localized non-melanoma skin cancer (e.g. basal cell or squamous cell carcinoma).
* The subject has a known current psychiatric condition, mental incapacity, language barrier or the inability to read that, in the judgment of the investigator, would impair the subject*s successful participation in the trial.
* The subject has a body mass index of * 40 kg/m2 as sign of morbid obesity.
* The subject has any condition that, in the investigator*s opinion, makes the subject unsuitable for study participation.
* The subject has received investigational therapy (i.e., not yet approved experimental medicine) within 28 days or 5 half-lives, whichever is longer, prior to the screening visit.;At randomization (Visit 2/Baseline)
* The 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.
* The result of the Visit 1/Screening serum pregnancy test is positive.
* The 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.