ONO-1110-08:Phase IIa study of ONO-1110 in Patients with Social Anxiety Disorder

ONO-1110-08: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 Social Anxiety Disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240578

Enrollment

100

Registered

2024-12-23

Start date

2025-01-31

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder

Interventions

The IMP is administered as follows according to the assigned administration group. - ONO-1110 group: Take ONO-1110 tablets once a day. - Placebo group: Take placebo tablets once daily.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Japanese participants (sex not specified) 2.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 3.Participants diagnosed with social anxiety disorder based on DSM-5-TR criteria, as determined through an interview using the M.I.N.I. 4.Outpatients 5.Participants with a LSAS-J total score of 70 or higher and a CGI-S score of 4 or higher

Exclusion criteria

Exclusion criteria: 1.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 (assessed using the M.I.N.I.) - Participants with a comorbid or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR

Design outcomes

Primary

Measure	Time frame
Efficacy: The change in the total LSAS-J score from baseline	—

Secondary

Measure	Time frame
Efficacy Safety: Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test, C-SSRS Pharmacokinetics	—

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD.

clinical_trial@ono-pharma.com+81-120-278-120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026