Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Study Overview
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Brief Summary
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The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.

Detailed Description
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This is a Phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of IW-3300 in subjects with IC/BPS. Subjects will be randomized 1:1:1 to IW-3300 100 µg, IW-3300 300 µg, or matching placebo administered as a rectal foam. The study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. Subjects will administer the study drug at home for 12 weeks.

Official Title
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A Phase 2 Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate the Efficacy, Safety, and Tolerability of 2 Dose Levels of IW-3300 Administered Rectally for 12 Weeks to Treat Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Conditions
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Interstitial Cystitis, Bladder Pain Syndrome

Intervention / Treatment
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* Drug: IW-3300 rectal foam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS Chronic bladder pain associated with filling the bladder over the past 6 months Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency Body mass index (BMI) ≤40 kg/m2 Willing to use a rectally administered product once daily for 12 weeks Exclusion Criteria: Male subject has history of bacterial prostatitis or benign prostatic hyperplasia Has a condition that can be a contraindication to using a rectal foam Has cancer under active treatment or a history of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer Has a history of benign or malignant bladder tumors Has an active urinary tract infection or had ≥2 UTIs within the past 90 days Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years Has a malabsorption syndrome Had surgery in the pelvic or abdominal region within the past 90 days Has received a cystoscopy (with or without hydrodistension for reason other than pain relief) for diagnostic purposes within the past 30 days or a cystoscopy involving therapeutic hydrodistension (for pain relief) within the past 90 days Has history of pelvic irradiation or radiation cystitis Has a recent history of drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IW-3300 100 µg<br>IW-3300 at 100 µg rectal foam administered daily for 12 weeks | Drug: IW-3300 rectal foam<br>* IW-3300 rectal foam administered daily for 12 weeks<br>|
| Experimental: IW-3300 300 µg<br>IW-3300 at 300 µg rectal foam administered daily for 12 weeks | Drug: IW-3300 rectal foam<br>* IW-3300 rectal foam administered daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo rectal foam administered daily for 12 weeks | Drug: Placebo<br>* Placebo rectal foam administered daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12 | Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary) | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CFB in weekly average of a burning sensation in the bladder at its worst at Week 12 | Subject assessment of bladder burning sensation at its worst will be reported via an eDiary | Baseline, Week 12 | 
| CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12 | Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary | Baseline, Week 12 | 
| CFB in weekly average of discomfort in the bladder at its worst at Week 12 | Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary | Baseline, Week 12 | 
| CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12 | The GUPI assesses the degree of symptoms with genitourinary pain complaints over the last week, including experience of pain or discomfort in various areas, frequency of pain/discomfort, average pain/discomfort, frequency of urinary symptoms, and quality of life (QoL) impact | Baseline, Week 12 | 
| Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects | Frequency of TEAEs occurring in ≥2% of subjects | Baseline, Week 12 | 
| Overall frequency of TEAEs by severity grade | Overall frequency of TEAEs by severity grade | Baseline, Week 12 |