A Clinical Study of ONO-1110 in Patients With Fibromyalgia

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 Fibromyalgia

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia

Study Overview

• Status: Active, not recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Placebo; Drug: ONO-1110

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Kyushu University Hospital
  • Tokyo, Japan
    • Yakushinkai Healthcare Association Kandasudacho Dermatology
  • Aichi-ken
    • Nagakute, Aichi-ken, Japan
      • Aichi Medical University Hospital
    • Nagoya, Aichi-ken, Japan
      • Kimura Clinic
  • Chiba
    • Yotsukaidō, Chiba, Japan
      • National Hospital Organization Shimoshizu National Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan
      • Ai Sakura Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Sapporo City General Hospital
  • Hyōgo
    • Katō, Hyōgo, Japan
      • Mayflower Hospital
  • Iwate
    • Morioka, Iwate, Japan
      • Shirasawa Orthopedic Clinic
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
      • Kokorotoitami Clinic
    • Yokohama, Kanagawa, Japan
      • Women's Clinic Luna
  • Miyazaki
    • Miyazaki, Miyazaki, Japan
      • Junwakai Memorial Hospital
  • Nagasaki
    • Ōmura, Nagasaki, Japan
      • Miyashita Rheumatology Clinic
  • Oita Prefecture
    • Ōita, Oita Prefecture, Japan
      • Medical Corporation Fujigaki Clinic
  • Okayama-ken
    • Okayama, Okayama-ken, Japan
      • Japanese Red Cross Okayama Hospital
  • Osaka
    • Osaka, Osaka, Japan
      • Hayaishi Hospital
    • Osaka, Osaka, Japan
      • Morimoto Clinic
  • Shizuoka
    • Shizuoka, Shizuoka, Japan
      • Shizuoka Rehab Pain Clinic
  • Tokyo
    • Tokyo, Tokyo, Japan
      • Fukuwa Clinic
    • Tokyo, Tokyo, Japan
      • Ginza Neurological Clinic
    • Tokyo, Tokyo, Japan
      • Himenotomomi Clinic
    • Tokyo, Tokyo, Japan
      • Ikebukuro Internal Medicine
    • Tokyo, Tokyo, Japan
      • Juntendo Tokyo Koto Geriatric Medical Center
    • Tokyo, Tokyo, Japan
      • Juntendo University Hospital
    • Tokyo, Tokyo, Japan
      • Juntendo University Nerima Hospital
    • Tokyo, Tokyo, Japan
      • Nihonbashi Medical
    • Tokyo, Tokyo, Japan
      • Nishiogi Pain Clinic
    • Tokyo, Tokyo, Japan
      • Sanno Hospital
    • Tokyo, Tokyo, Japan
      • Tokyo-Eki Center-building Clinic
  • Toyama
    • Toyama, Toyama, Japan
      • Toyama University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Japanese (both sexes)
• Outpatient
• Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)
• Patients who meet the American College of Rheumatology Fibromyalgia Criteria

Exclusion Criteria:

• Patients with inflammatory arthritis, infectious arthritis, or autoimmune disease
• Patients with pain other than FM 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 with a past history of or concurrent malignant tumor within 3 years
• Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.

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 8 of the treatment period	Up to 16 weeks
Adverse events	Up to 16 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 16 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 16 weeks
Change in weekly mean of worst pain score from baseline to each week		Up to 16 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 16 weeks
Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline		Up to 16 weeks
Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline		Up to 16 weeks
Change in Patient Global Impression of Change (PGIC) score from baseline		Up to 16 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline		Up to 16 weeks
Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline		Up to 16 weeks
Plasma ONO-1110 concentrations		Up to 16 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): March 26, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 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 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Fibromyalgia; ONO-1110; ONO-1110-05
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia
• Other Study ID Numbers: ONO-1110-05; jRCT2031240522 (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