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

Phase 2

Recruiting

• Conditions: Social Anxiety Disorder (SAD)
• Interventions: Drug: ONO-1110; Drug: Placebo

• Registration Number: NCT06805565
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-16
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-02-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-01
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 (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)
4. Outpatients
5. 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

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 (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

2. 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

3. Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher

4. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONO-1110	ONO-1110	-
ONO-1110	Placebo	-
Placeo	ONO-1110	-
Placeo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Responder is defined as a reduction of 30% or more in LSAS-J(Liebowitz Social Anxiety Scale Japanese version)total score from baseline
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	Remitted patient is defined as a LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score of 30 or less.
Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 12 of the treatment period	Up to 19 weeks
Transition of SDISS(Sheehan Disability Scale) score from baseline to Week 12 of the treatment period	Up to 19 weeks
Plasma ONO-1110 concentrations	Up to 19 weeks
Adverse Events	Up to 19 weeks

Trial Locations

Locations (1)

Kokura Mental Clinic; 🇯🇵 Fukuoka, Japan