Bladder Pain Syndrome Interstitial Cystitis
Conditions
Interventions
The investigational medicinal product (IMP) is KU002 (active pharmaceutical
ingredient is brimapitide), given intravesically through bladder
catheterization. All subjects in this study will receive
Sponsors
Kuste Biopharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years of age. 2. Willing to provide written informed consent. 3. Willing and able to comply with study requirements and visit schedule. 4. Have a diagnosis of IC/BPS for at least 6 weeks prior to screening. 5. Have undergone a cystoscopy and have visible signs of Hunner*s lesion (photo documented) within 6 weeks prior to study inclusion. If the cystoscopy was not performed within 6 weeks of study inclusion, a new cystoscopy (incl photo of the Hunner*s lesion) must form part of the screening eligibility procedure. 6. Have an average daily pain score (recorded over 3 days) > 4 but <9 on the 11-point Numerical Rating Scale (NRS) in the 3 days prior to inclusion. 7. Be ambulatory and able to use the toilet independently. 8. Have a body mass index >=19 kg/m2 but
Exclusion criteria
Exclusion criteria: 1. Current or recent (30 days prior to screening) change in any pharmacologic agent or invasive procedure (e.g. fulguration) used to treat the IC/BPS condition. Patient is eligible to participate in the study if their treatment for IC/BPS has remained stable for the past month prior to entry. 2. Concurrent (at Screening), recent (within 30 days), chronic, or recurrent (>4 per year) urinary tract infections (positive dipstick for urinary tract infection and abnormal microscopic evaluation, signs and symptoms) or unevaluated microhematuria. 3. Having a history of previous procedure that affects bladder function (e.g. augmentation, cystoplasty, cystectomy, partial bladder resection, cystolysis etc.). 4. History of cyclophosphamide or chemical cystitis, urinary tuberculosis, radiation cystitis or history of pelvic irradiation. 5. Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy), during the previous month prior to Screening, or the intention to initiate such therapies during the study. 6. Postvoid residual (PVR) urine volume >150 mL. 7. Diagnosis of dementia. 8. Subjects with uncontrolled hypertension. 9. Documented history of myocardial infarction, unstable angina, and/or has undergone coronary artery bypass surgery and/or percutaneous transluminal coronary angioplasty in the past year. 10. Congestive heart failure (New York Heart Association Class III or IV heart failure). 11. Any concurrent condition or any clinically significant abnormality on the Screening physical examination, laboratory tests, electrocardiogram (ECG; including ischemic heart disease), Hepatitis B or C, which, in the opinion of the Investigator, may affect the interpretation of efficacy or safety data, or which otherwise contraindicates participation in a clinical study with KU002. a) Hypersensitivity to KU002 or any of its ingredients. b) History of clinically significant drug hypersensitivity. c) History of urogenital neoplasms or malignancies including bladder, urethra, uterine, cervical or vaginal cancer. d) For men: history of prostate surgery (transurethral resection of the prostate [TUR-P], transurethral resection of tumor, [TUR-T], transurethral incision of the prostate [TUIP], transurethral needle ablation [TUNA]), history of prostate cancer or currently (within 30 days) being treated for chronic bacterial prostatitis. e) Subjects with neuropathology that could affect the lower urinary tract or nerve supply, including but not limited to multiple sclerosis, stroke, Parkinsonism, or spinal cord injury. f) Clinically significant or unstable endocrine, hepatic, renal, immunologic (incl immune suppressive and autoimmune) disease or malignancy other than non-melanomatous skin cancer. 12. Severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73m2). 13. Hepatic impairment (Child-Pugh B or greater). 14. Use of medications for BPH (eg Tamsulosin, silodosin, alfulozin and finasteride) within a month prior to study entry. 15. History of an addiction to drugs or alcohol within the last 2 years prior to Screening as determined by the Investigator. 16. Participation in a clinical study within a month prior to Screening, or exposure to an investigational drug which has not washed out for at least 5 half-lives since the las
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Incidence and severity of AEs over the course of the study. • Hematology, biochemistry, and urinalysis. While total white blood cell (WBC) count will be expressed in absolute values, differential count will be expressed as both absolute count and percentage of WBCs. • Absolute change from baseline to EoT+1 in ECG readings. • ECG parameters of interest include ventricular rate, QT interval, corrected QT interval, PR interval, and QRS duration. • Absolute change from baseline to each visit in standardized cuff systolic and diastolic blood pressure and radial heart rate. • Pharmacokinetics: Determination of concentration of KU002 in plasma at the given time points, presented descriptively. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Absolute change in pain, measured as mean value over 3 days, on the 11-point Numerical Rating Scale from baseline to EoT+1. • Change in O*Leary Sant ICSI-ICPI participant reported questionnaire from baseline to EoT+1. • Responder analysis: Proportion of subjects who have at least a 2-point reduction in pain score measured by NRS between baseline and EoT+1. • Change in the maximum daily pain score from baseline to EoT+1. • Change in Subject*s Global Response Assessment (GRA) at EoT+1. • Change in NRS, O*Leary Sant ICSI-ICPI after 3 instillations and to EoT+1. • Change in 3-day voiding diary from baseline to EoT+1. • A visual inspection of Hunner*s lesion before and after treatment to determine any effect on the lesion. | — |
Countries
Netherlands
Outcome results
None listed