A Study of ONO-1110 in Patients With Social Anxiety Disorder

NCT06805565 | Active Not Recruiting Phase 2

• 2 other identifiers: ONO-1110-08jRCT2031240578
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 27

Brief Summary

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder

Conditions

Social Anxiety Disorder (SAD)

Outcome Measures

Primary Outcomes (1)

• Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period

  Up to 19 weeks

Secondary Outcomes (9)

• The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 8 of the treatment period

  Up to 19 weeks

• The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Fear or Anxiety score from baseline to Week 8 of the treatment period

  Up to 19 weeks

• The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Avoidance score from baseline to Week 8 of the treatment period

  Up to 19 weeks

• Responder rates of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score at 1, 2, 4, 6, 8,10and 2 weeks of the treatment period

  Up to 19 weeks

• Remitted patient rates of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score at 1, 2, 4, 6, 8, 10 and 12 weeks of the treatment period

  Up to 19 weeks

Study Arms (2)

ONO-1110

EXPERIMENTAL

Drug: ONO-1110; Drug: Placebo

Placeo

PLACEBO COMPARATOR

Drug: ONO-1110; Drug: Placebo

Interventions

ONO-1110 DRUG

ONO-1110 tablets once a day

ONO-1110; Placeo

Placebo DRUG

Placebo tablets once daily

ONO-1110; Placeo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese participants (sex not specified)
• Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements
• Participants diagnosed with social anxiety disorder based on DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria, as determined through an interview using the M.I.N.I. (Mini-international neuropsychiatric interview)
• Outpatients
• Participants with a LSAS-J (Liebowitz Social Anxiety Scale Japanese version) total score of 70 or higher and a CGI-S (Clinical global impression-Severity) score of 4 or higher

You may not qualify if:

• Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:
• Participants with a comorbid psychiatric disorder other than social anxiety disorder as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) (assessed using the M.I.N.I. (Mini-international neuropsychiatric interview))
• Participants with a comorbid or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
• Participants with neurodevelopmental disorders, neurocognitive disorders, or personality disorders (excluding avoidant personality disorder) as defined by DSM-5-TR
• Participants who have been primarily diagnosed with a disorder other than social anxiety disorder according to DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria within 24 weeks prior to screening
• Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher
• Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different SSRIs (Selective serotonin reuptake inhibitor), each administered at an adequate dose for at least 10 weeks, in treating social anxiety disorder

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (27)

Aisakura Clinic

Fukuoka, Japan

Location

AK Clinic

Fukuoka, Japan

Location

Hiro Mental Clinic

Fukuoka, Japan

Location

Hirota Clinic

Fukuoka, Japan

Location

Kokorono Clinic Hirao

Fukuoka, Japan

Location

Kokura Mental Clinic

Fukuoka, Japan

Location

Mental Clinic Sakurazaka

Fukuoka, Japan

Location

Shinseikai Kaku Mental Clinic

Fukuoka, Japan

Location

Uematsu Mental Clinic

Fukuoka, Japan

Location

Ichikawa Clinic

Gunma, Japan

Location

Higashi-Sapporo Mental Clinic

Hokkaido, Japan

Location

Kawamura Mental Clinic

Hokkaido, Japan

Location

Minami1jo Mental Clinic

Hokkaido, Japan

Location

Sapporo Kobushi Clinic

Hokkaido, Japan

Location

Shimode Mental Clinic

Hokkaido, Japan

Location

Tatsuta Clinic

Hyōgo, Japan

Location

Yutaka Clinic

Kanagawa, Japan

Location

Ai Clinic

Miyazaki, Japan

Location

Inoue Clinic

Osaka, Japan

Location

Yamaguchi Mental Clinic

Tokushima, Japan

Location

Harai Clinic

Tokyo, Japan

Location

Iidabashi Mental Clinic

Tokyo, Japan

Location

Ikebukuro Olive Mental Clinic

Tokyo, Japan

Location

Maynds Tower Mental Clinic

Tokyo, Japan

Location

Meguroeki Higashiguchi Mental Clinic

Tokyo, Japan

Location

Monzen-nakacho Mental Clinic

Tokyo, Japan

Location

Sangenjaya Nakamura Mental Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (27)