N-[4-[2-[4-(3-CYANOPHENYL)PIPERAZIN-1-YL]ETHYL]CYCLOHEXYL]-3-METHOXYPROPANAMIDE for Obsessive compulsive disorder

Inclusion criteria

• {"criterion_text":"- 1. Written informed consent obtained prior to any trial-related procedures.\n- 2. Male or female ≥18-75 years old.\n- 3. Primary diagnosis of OCD for ≥1 year with or without previous or current tic, as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision. Participant must have good/fair insight of their condition where he or she recognizes obsessions/compulsions are excessive or unreasonable.\n- 4. Moderate to severe OCD: Current total YBOCS-II score of ≥22 at screening and randomization, with no more than 35% of improvement or worsening in the score from screening to randomization visit.\n- 5. Participants who are receiving evidence-based pharmacologic treatment for OCD at an appropriate therapeutic dose and duration and demonstrate only a partial/insufficient response (i.e., failure to achieve clinically significant symptom improvement).\n- 6. Participants must have had stable doses of concomitant psychiatric medications for at least 8 weeks prior to screening and at least 12 weeks prior to randomization.\n- 7. Participants must have a cooperative attitude and be able to understand and comply with the entire trial requirements and procedures (e.g., trial-related questionnaire, drug compliance, not use prohibited concomitant medications).\n- 8. Female participant: post-menopausal woman having at least 12 months of natural (spontaneous) amenorrhea without any alternative medical cause, or woman of childbearing potential (WOCBP, defined as all fertile women, following menarche and until becoming post-menopausal unless permanently sterile; permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) using a highly effective method of contraception for the duration of the trial and for one (1) month after stopping the investigational medication.\n- 9. If required, participant must be insured by appropriate national health insurance system."}

Exclusion criteria

• {"criterion_text":"- 1. Participants with poor or absent/delusional insight of their OCD condition per DSM-5-TR, i.e., participants who think their obsessions/compulsions are likely reasonable or hold delusional convictions about them.\n- 18. Participant with a clinically significant deviation(s) from normal on 12-lead ECG that results in an active medical problem, as determined by the Investigator at screening or has a corrected QT interval using Fridericia’s formula (QTcF) ≥450 msec for males or ≥470 msec for females.\n- 2. Current or prior history of schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, intellectual disability, dementia, or mild/severe neurocognitive disorder, borderline personality disorder, and antisocial personality disorder.\n- 3. Unstable/uncontrolled bipolar I or II disorder.\n- 4. Current (or in the last 1 year) main diagnosis of Tourette's disorder, body dysmorphic disorder, hoarding disorder, impulse control disorder, body-focused repetitive behaviours (e.g., skin picking disorder, trichotillomania), anorexia nervosa or any other eating disorder.\n- 5. Documented resistance to antipsychotic augmentation: Participants with well-documented nonresponsiveness to antipsychotic augmentation within the past 2 years, defined as a failure to achieve clinically significant symptom improvement relative to their pre-augmentation baseline following the addition of an antipsychotic to an ongoing OCD pharmacotherapy regimen at an appropriate therapeutic dose and duration. Participants who discontinued antipsychotic augmentation prematurely or did not receive a full therapeutic trial/duration (for any reason) are not considered exclusionary under this criterion.\n- 6. Participants who are unable or unlikely to maintain a stable dose of their current, approved OCD medication(s) throughout the trial, including those anticipated to require initiation of a new pharmacologic regimen (e.g., switch between SSRIs or to/from clomipramine, or augmentation) during the study period, or with a history of non-adherence to psychiatric medications.\n- 7. Concomitant prolactin-dependent tumour (e.g., pituitary tumour or breast cancer).\n- 8. Participants who had psychosurgery or have a Deep Brain Stimulation (DBS).\n- 9. Electroconvulsive therapy (ECT) or Transcranial Magnetic Stimulation (TMS) in the past 3 months.\n- 19. Participant with unstable concurrent uncontrolled or unstable disease that might affect the participant’s safety and/or interfere with the conduct of the trial according to the Investigator’s judgement.\n- 10. Participants who are on unstable dose of anxiolytics, hypnotics, or daridorexant, and are unwilling, or its not clinically possible, to maintain a stable dose during the trial.\n- 20. \tParticipant who has a laboratory abnormality at screening as follows: _ALT, AST values > 2 x ULN _Serum creatinine value >1.5 x ULN _GFR < 50 mL/min/1.73 m² (CKD-EPI formula) _Absolute neutrophils count <1.0x109 /L _Platelets < 100x109 /L _or who has any other uncontrolled clinically significant laboratory abnormalities that would affect interpretation of the trial data or the participant’s participation in the trial. Note: one retest will be allowed during the screening period if the investigator believes the abnormality is transient and not clinically significant.\n- 21. History of hypersensitivity to any of the trial drug constituents.\n- 22. Participant having received any other investigational drug within the preceding 30 days, or a longer and more appropriate time as determined by the Investigator (e.g., approximately five half-lives of the previous investigational drug).\n- 23. To the opinion of the investigator, participants who may be uncooperative, or who are in particular legal, non-legal, or life circumstances that could prevent them from adhering to the trial protocol, should be excluded.\n- 11. Any history of Substance-Related and Addictive Disorders (excluding nicotine and caffeine).\n- 12. \tRegular (daily or weekly) use of psychoactive cannabis with tetrahydrocannabinol (i.e., including non-psychoactive cannabidiol), or hallucinogens [e.g., lysergic acid diethylamide (LSD), psilocybin (“magic mushrooms”), 3,4-Methylenedioxymethamphetamine (MDMA), ibogaine, dimethyltryptamine (DMT), ayahuasca, non-prescribed ketamine/esketamine, etc.].\n- 13. Active suicidality (i.e., any suicide attempts in the past 12 months or any ongoing suicidal intent, as assessed by the C-SSRS score of “YES” on questions 4 or 5; and/or based on clinical evaluation by the investigator).\n- 14. Psychological (e.g., supportive psychotherapy, cognitive behaviour therapy, interpersonal therapy) intervention for OCD that was begun within the 3 months before trial entry. Participants on such treatment for more than 3 months prior to screening may be enrolled if they agree not to make any changes to the frequency or nature of their treatment during the course of the trial.\n- 15. Brain damage, or other cognitive impairment that would interfere with the capacity to participate in the trial and complete measures.\n- 16. Female participants: pregnant or lactating women. [Pregnancy is confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5mIU/mL). Serum pregnancy test will be done at screening and urine test at randomisation].\n- 17. History of significant cardiovascular disease, particularly recent history of myocardial infarction or unstable coronary artery disease, arrhythmias, congestive heart failure, uncontrolled arterial hypertension. Participant with a known history of long QT syndrome with or without history of syncope."}

Primary endpoints

• {"endpoint_text":"- The primary efficacy endpoint is the change in the total score on the Yale-Brown ObsessiveCompulsive Scale Second Edition (YBOCS-II) at end of treatment.","definition_or_measurement_approach":"Change in the total YBOCS-II score at end of treatment measured using the Yale-Brown Obsessive-Compulsive Scale Second Edition (YBOCS-II)."}

Secondary endpoints

• {"endpoint_text":"- Change in total score of the YBOCS-II at visits 3 and 4","definition_or_measurement_approach":"Change in total YBOCS-II score measured at visits 3 and 4."}
• {"endpoint_text":"- Change in total score of Obsessive-Compulsive Inventory-Revised (OCI-R) at visits 3, 4 and 5","definition_or_measurement_approach":"Change in total OCI-R score measured at visits 3, 4 and 5 using the OCI-R instrument."}
• {"endpoint_text":"- Change in global functioning responses as assessed on the Clinical Global Impressions – Change (CGI-C) scale","definition_or_measurement_approach":"Global functioning change assessed by the CGI-C scale."}
• {"endpoint_text":"- Change in total score of Montgomery and Asberg Depression rating scale (MADRS)","definition_or_measurement_approach":"Change in total MADRS score measured with the MADRS instrument."}

Portugal

Earliest CTIS Part Ii Submission Date

28-10-2025

Latest Decision Or Authorization Date

16-12-2025

Processing Time Days

49

Number Of Sites

4

Number Of Participants

12

Italy

Earliest CTIS Part Ii Submission Date

18-11-2025

Latest Decision Or Authorization Date

01-04-2026

Processing Time Days

134

Number Of Sites

3

Number Of Participants

12

Spain

Earliest CTIS Part Ii Submission Date

19-11-2025

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

117

Number Of Sites

7

Number Of Participants

20

Poland

Earliest CTIS Part Ii Submission Date

20-11-2025

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

138

Number Of Sites

6

Number Of Participants

10

Primary sponsor

Full Name

Bioprojet Pharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

France