A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of BNC210 compared to placebo on PTSD symptom severity as measured by CAPS-5 Total Symptom Severity Scores.

Detailed Description
-----------------
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study with a 12 week, 2-arm treatment period. Participants will attend a Screening visit within 3 weeks before randomization to confirm eligibility. Approximately 200 participants will be randomized using a 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched placebo. Participants will then complete 12 weeks of treatment with their allocated study intervention. Participants will return to their study site at 4-weekly intervals to receive study intervention and complete safety and efficacy assessments. Participants are then requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study intervention is administered).

Official Title
-----------------
A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: BNC210
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with a current diagnosis of PTSD as defined by the CAPS-5 for DSM-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at Screening and Baseline and no >25% decrease in Score from Screening to Baseline The index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age Suitable contraception use in line with protocol requirements Ability to swallow tablets Exclusion Criteria: A period of less than 6 months since the index trauma event Current and ongoing exposure to the trauma that caused the PTSD Complex PTSD Severe depression as measured by a score of ≥ 35 on the MADRS Borderline personality disorder, bipolar disorder and other psychotic disorders Use of antidepressant medications within 30 days (fluoxetine within 90 days) of Screening. The use of alprazolam, flunitrazepam and chronic daily use of other benzodiazepines within 90 day of Screening. Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD. Concurrent trauma-based psychotherapy such as Cognitive Behavior Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy. Participants may however continue to receive supportive counseling that has been in place for a minimum of three months prior to Screening. Any moderate or severe substance use disorder in the past 12 months Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNC210<br> | Drug: BNC210<br>* BNC210 900 mg twice daily (b.i.d.) for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo twice daily (b.i.d.) for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Change from Baseline on Investigator-rated symptoms of PTSD (total symptom severity scores) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Change from Baseline on Investigator-rated symptom clusters of PTSD (symptom cluster scores) | 12 Weeks | 
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Response rate and remission rate using Investigator-rated symptoms of PTSD (total symptom severity scores) | 12 weeks | 
| PTSD Checklist for DSM-5 (PCL-5) | Change from Baseline on patient-reported symptoms of PTSD | 12 weeks | 
| Montgomery Asberg Depression Rating Scale (MADRS) | Change from Baseline on Investigator-rated symptoms of depression | 12 Weeks | 
| Hamilton Anxiety Rating Scale (HAM-A) | Change from Baseline on Investigator-rated symptoms of anxiety | 12 Weeks | 
| Clinician Global Impression (CGI) | Change from Baseline on Investigator-rated global functioning | 12 weeks | 
| Patient Global Impression (PGI) | Change from Baseline on patient-reported global functioning | 12 weeks | 
| Insomnia Severity Index (ISI) | Change from Baseline on patient-reported sleep quality | 12 weeks | 
| Sheehan Disability Scale (SDS) | Change from Baseline on patient-reported social functioning | 12 weeks |