A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis

A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Hunner Type Interstitial Cystitis

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis

Study Overview

• Status: Active, not recruiting
• Conditions: Hunner Type Interstitial Cystitis
• Intervention / Treatment: Drug: Placebo; Drug: ONO-1110

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Nagasaki, Japan
    • Nagasaki University Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan
      • Nagoya University Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan
      • Harasanshin Hospital
  • Fukushima
    • Fukushima, Fukushima, Japan
      • Fukushima Medical University Hospital
  • Gifu
    • Gifu, Gifu, Japan
      • Japanese Red Cross Gifu Hospital
  • Gunma
    • Takasaki, Gunma, Japan
      • Kurosawa Hospital Health Park Clinic
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan
      • Niimura Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
      • Kanto Rosai Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan
      • Rakuwakai Marutamachi Hospital
    • Kyoto, Kyoto, Japan
      • Ueda Clinic
  • Miyagi
    • Sendai, Miyagi, Japan
      • Izumi Chuo Hospital
  • Nagano
    • Matsumoto, Nagano, Japan
      • Shinshu University Hospital
  • Oita Prefecture
    • Beppu, Oita Prefecture, Japan
      • Nakamura Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan
      • Okayama University Hospital
  • Saga-ken
    • Saga, Saga-ken, Japan
      • Nanri Urological Clinic
  • Tokyo
    • Minato-Ku, Tokyo, Japan
      • The Jikei University Hospital
    • Mitaka, Tokyo, Japan
      • Kyorin University Hospital
    • Tokyo, Tokyo, Japan
      • The University of Tokyo Hospital
  • Toyama
    • Uozu, Toyama, Japan
      • Toyama Rosai Hospital
  • Yamanashi
    • Chūō, Yamanashi, Japan
      • University of Yamanashi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Japanese (both sexes)
• Age (at the time of informed consent): 18 years and older
• Outpatient
• Patients who are considered capable of understanding the study procedures and completing the pain diary, bladder diary, and questionnaires appropriately by the investigator (sub-investigator）
• Patients given a diagnosis of HIC by cystoscopy
• Patients with chronic pelvic pain involving the bladder and lower urinary tract symptoms such as increased micturition and pollakiuria

Exclusion Criteria:

• Patients with a history and presence of chemical cystitis
• Patients with a history of bladder augmentation or radical cystectomy
• Patients with pain other than HIC that may affect assessments in this study
• Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
• Patients receiving medications for psychiatric disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo tablets once daily	Drug: Placebo; Placebo tablets once daily
Experimental: ONO-1110; ONO-1110 tablets once a day	Drug: ONO-1110; ONO-1110 tablets once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weekly mean of average pain score from baseline to Week 12 of the treatment period	Up to 20 weeks
Adverse events	Up to 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weekly mean of average pain score from baseline in each week		Up to 20 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score	proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively	Up to 20 weeks
Change in weekly mean of worst pain score from baseline to each week		Up to 20 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score	proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively	Up to 20 weeks
Change in Interstitial cystitis symptom index (ICSI) score from baseline		Up to 20 weeks
Change in Interstitial cystitis problem index (ICPI) score from baseline		Up to 20 weeks
Change in Average frequency of urination per day from baseline		Up to 20 weeks
Change in Frequency of nocturnal urination per day from baseline		Up to 20 weeks
Change in Mean volume voided per micturition in a day from baseline		Up to 20 weeks
Change in Maximum volume voided per micturition in a day from baseline		Up to 20 weeks
Change in Number of urgency episodes per day from baseline		Up to 20 weeks
Change in Patient Global Impression of Change (PGIC) score from baseline		Up to 20 weeks
Change in SF-12v2 score from baseline		Up to 20 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline		Up to 20 weeks
Plasma ONO-1110 concentrations		Up to 20 weeks

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): December 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ONO-1110; ONO-1110-06; Hunner Type Interstitial Cystitis
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: ONO-1110-06; jRCT2031240558 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No