Business decision

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.

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.

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 with active symptoms that are difficult to distinguish from IC/BPS
• 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, colorectal, 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 or is planning pelvic or abdominal region surgical procedures before the end of the study
• Has received a cystoscopy with or without hydrodistension for diagnostic purposes (ie, not for pain relief) within the past 30 days or a cystoscopy with therapeutic hydrodistension (ie, for pain relief) within the past 90 days or is planning a cystoscopy for any reason before the end of the study
• Has history of pelvic irradiation or radiation cystitis, or drug-induced cystitis.
• Has a recent history of drug or alcohol abuse

Ironwood Pharmaceuticals, Inc. is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to deidentified/pseudonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols, statistical analysis plans, clinical study report synopses) for Phase 2 through 4 trials that are not part of an ongoing or planned regulatory submission or are from a terminated program.

These clinical trial data can be requested by any qualified researchers who engages in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data user agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the link below.