Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population

NCT04932291 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CL07-ORY-2001
• Study Type: interventional
• Target: 211
• Locations: 5 countries
• Sites: 21

Brief Summary

PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.

Conditions

Borderline Personality Disorder

Keywords

Borderline personality disorder; vafidemstat

Outcome Measures

Primary Outcomes (2)

• Efficacy: Difference in the CGI-S A/A From Baseline to Average of Weeks 8 to 12

  Change on the CGI-S A/A from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set). * Full scale name: Clinical Global Impression-Severity focused on Agitation/Aggression * Scale construct: the CGI-S A/A is a clinician's global rating of the BPD patients' severity of agitation and aggression symptoms at the time of evaluation. * Scale items: 1. * Scale range values: 0 to 7. Higher scores reflect greater severity of BPD-related agitation and agression symptoms. * Scale score: 0 (min) - 7 (max).

  From Baseline-Week 0 to average of Weeks 8 to 12

• Efficacy: Difference in the BPDCL-Total Score From Baseline to Average of Weeks 8 to 12

  Change on the BPDCL-Total Score from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set). * Full scale name: Borderline Personality Disorder Checklist. * Scale construct: the BPDCL is a patient-reported outcome measure of BPD symptoms' severity over the past 2 weeks. The Total Score is a global score representing overall BPD symptom burden. * Scale items: 47 items. * Scale range values: 1 to 5 for each item. * Scale score: Total Score=47 (min) - 235 (max) as the sum of the 47 items scores. Higher scores reflect greater severity of BPD symptoms.

  From Baseline-Week 0 to average of Weeks 8 to 12

Secondary Outcomes (16)

• Efficacy: Difference in the BEST-Total Score From Baseline to Average of Weeks 8 to 12

  From Baseline-Week 0 to average of Weeks 8 to 12

• Efficacy: Difference in the BDI-II Total Score From Baseline to Average of Weeks 8 to 12

  From Baseline-Week 0 to average of Weeks 8 to 12

• Efficacy: Difference in the STAXI-2-State Anger Subscale Score From Baseline to Average of Weeks 8 to 12

  From Baseline-Week 0 to average of Weeks 8 to 12

• Efficacy: Difference in the STAXI-2-Trait Anger Subscale Score From Baseline to Average of Weeks 8 to 12

  From Baseline-Week 0 to average of Weeks 8 to 12

• Efficacy: Difference in the STAXI-2-Anger Expression Index Subscale Score From Baseline to Average of Weeks 8 to 12

  From Baseline-Week 0 to average of Weeks 8 to 12

Study Arms (2)

vafidemstat 1.2mg

EXPERIMENTAL

Vafidemstat is administered as capsules.

Drug: vafidemstat

placebo

PLACEBO COMPARATOR

Placebo is administered as capsules.

Drug: Placebo

Interventions

vafidemstat DRUG

1.2mg capsule

Also known as: ORY-2001

vafidemstat 1.2mg

Placebo DRUG

placebo capsule

placebo

Eligibility Criteria

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

You may qualify if:

• Men and women 18-65 years of age.

You may not qualify if:

• Agitation-Aggression Psychiatric Inventory-Clinician Report (AAPI-CR) Agitation \& Aggression (A/A) subscale score of ≥ 16 (severity x frequency) summed across the four (4) items comprising the A/A subscale, and the sum of the A/A subscale severity scores ≥ 6.
• Stable living environment for \> 6 months before the Screening visit.
• Body mass index (BMI) of at least 18.5 kg/m2, but no more than 35 kg/m2.
• Willing and able to adhere to the prohibitions, restrictions and requirements specified in this protocol.
• Otherwise, healthy, and medically stable based on medical history.
• Clinical and neurological examinations and laboratory tests, as well as 12-lead ECG performed during screening that confirms subject is healthy and medically stable.
• Able to read and write fluently and must have adequate hearing and visual acuity to complete the required testing outlined in this protocol.
• Stable in their permitted regimen of background therapy as per drug labeling for concomitant medications at the Screening visit and they should maintain treatment throughout the study and not initiate any prohibited medications during the trial. Subjects should agree to inform their study physician of any medication changes throughout the trial.
• Enrolled subjects will need to maintain their pre-screening psychotherapy schedule throughout the trial duration. That is, subjects receiving psychotherapy will need to have it started at least 3 months before the Screening visit and remain in psychotherapy throughout the trial. Subjects not receiving psychotherapy should not initiate psychotherapy during the trial.
• Fertile male and female subjects must use highly efficient contraception, from the Screening visit until 30 days after last dose of the IMP, defined as:
• A method with less than 1% failure rate (e.g., permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner) OR The use of two methods of contraception (e.g., one barrier method \[condom, diaphragm or cervical/vault caps\] with spermicide and one hormonal contraceptive \[e.g., combined oral contraceptives, patch, vaginal ring, injectable and implants\])
• Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline.
• Signed informed consent by participant prior to the initiation of any study specific procedure.
• Failure to perform screening or baseline procedures.
• DSM-5 diagnosis of intellectual disability, autism spectrum disorder, schizophrenia, schizoaffective disorder, bipolar disorder (or related disorders) or major depressive disorder (MDD) with psychosis.

Sponsors & Collaborators

• Oryzon Genomics S.A.: lead

Study Sites (21)

Excell Research Inc

Oceanside, California, 92056, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

New Life Medical Research Center

Hialeah, Florida, 33012, United States

Location

Phoenix Medical Research LLC

Miami, Florida, 33165, United States

Location

University of Chicago Institutional Review Board

Chicago, Illinois, 60637-1426, United States

Location

Revive Research Institute

Elgin, Illinois, 60123, United States

Location

Adams Clinical Trials, LLC

Watertown, Massachusetts, 02472, United States

Location

Center for Emotioal Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Neurobehavioral Research Inc.

Cedarhurst, New York, 11516, United States

Location

The Medical Research Network

New York, New York, 10128, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

Medical Center Intermedika

Sofia, Sofia-Grad, 1680, Bulgaria

Location

Medical Center Hera EOOD - Psychiatry Office

Sofia, Sofia-Grad, 9000, Bulgaria

Location

DCC "Mladost-M" Ltd, Psychiatr

Varna, 9000, Bulgaria

Location

Klinik fur Psychiatrie und Psychotherapie, LMU

München, Bavaria, 80336, Germany

Location

Emovis GmbH

Berlin, 10629, Germany

Location

Clinic for psychiatric disorders "Laza Lazarevic"

Belgrade, 11000, Serbia

Location

Clinical center of Serbia

Belgrade, 11000, Serbia

Location

Clinical center Kragujevac

Kragujevac, 3400, Serbia

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

vafidemstat

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Rolando Gutierrez - Chief Medical Officer
• Organization: Oryzon Genomics S.A.

rgutierrez@oryzon.com

+34 93 515 1313

Study Officials

• Michael Ropacki, MD

  Oryzon Genomics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: April 12, 2021
• First Posted: June 21, 2021
• Study Start: March 26, 2021
• Primary Completion: October 30, 2023
• Study Completion: November 13, 2023
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BU (3); US (11); DE (2); ES (2); SE (3)