A multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 2a trial to evaluate the efficacy and safety of BP1.4979 in adult participants with obsessive compulsive disorder
- Trial ID
- 2025-522026-13-00
- Protocol
- P24-05
- Sponsor
- Bioprojet Pharma
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the safety, tolerability, and efficacy of BP1.4979 in treating obsessive-compulsive disorder (OCD). This objective is clinically relevant as it aims to determine whether BP1.4979 represents a viable therapeutic option for adults with OCD, addressing the need for effective pharmacological interventions in this patient population.
The secondary objective is assessing the correlation between changes in depressive symptoms and improvement in OCD symptom severity. This evaluation is important given the frequent comorbidity of depressive symptoms in patients with OCD and the potential impact of mood changes on overall treatment response.
Participants
The sponsor did not provide information regarding the total number of participants enrolled in this clinical trial. The study population consisted of both **male and female participants** aged **18 to 75 years**. Participants were required to have a primary diagnosis of **obsessive compulsive disorder** (OCD) for at least one year, with **moderate to severe** disease severity as indicated by a Yale-Brown Obsessive Compulsive Scale-II (YBOCS-II) score of at least 22 at screening and randomization. The trial population was selected to include individuals demonstrating **partial or insufficient response** to evidence-based pharmacologic treatment for OCD at appropriate therapeutic doses and duration. Participants were required to maintain **stable doses** of concomitant psychiatric medications for specified periods prior to enrollment. Key selection criteria included the presence of good or fair **insight** into their condition, recognizing that obsessions or compulsions were excessive or unreasonable. Female participants of childbearing potential were required to use highly effective contraception methods throughout the trial duration. The study population included a **vulnerable population** as designated in the trial classification.
Plans and Procedures
This is a multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 2a clinical trial designed to evaluate the efficacy and safety of **BP1.4979** in adult participants with **obsessive compulsive disorder**. The trial employs a rigorous methodology wherein participants are randomly assigned to receive either the investigational medicinal product or a matching **placebo**, with both participants and investigators remaining blinded to treatment allocation throughout the study period. The investigational product BP1.4979 is administered as a **tablet** for **oral use**, with a maximum daily dose of 40 mg and a maximum total dose of 3360 mg over a treatment period of 12 weeks. The primary objective is to evaluate the safety, tolerability, and efficacy of BP1.4979 in treating obsessive compulsive disorder.
Eligible participants must be male or female adults aged 18 to 75 years with a primary diagnosis of obsessive compulsive disorder for at least one year, demonstrating moderate to severe symptoms as evidenced by a **Yale-Brown Obsessive-Compulsive Scale Second Edition** (YBOCS-II) total score of at least 22 at both screening and randomization. Participants must exhibit good or fair insight into their condition and must be receiving evidence-based pharmacologic treatment at an appropriate therapeutic dose and duration with only partial or insufficient response. Stable doses of concomitant psychiatric medications must be maintained for at least 8 weeks prior to screening and 12 weeks prior to randomization. Female participants of childbearing potential must use highly effective contraception for the duration of the trial and for one month following cessation of investigational medication. Participants must provide written informed consent prior to any trial-related procedures and demonstrate the ability to understand and comply with all trial requirements and procedures.
The primary efficacy endpoint is the change in total score on the YBOCS-II at the end of treatment. Secondary endpoints include changes in total YBOCS-II scores at intermediate visits, changes in total score of the **Obsessive-Compulsive Inventory-Revised** (OCI-R), changes in global functioning as assessed by the **Clinical Global Impressions – Change** (CGI-C) scale, and changes in total score of the **Montgomery and Asberg Depression Rating Scale** (MADRS). The trial involves a structured series of visits including a screening visit for assessment of eligibility criteria, a randomization visit, follow-up visits at weeks 3 and 4, and an end-of-study visit at week 5. Participant involvement spans approximately 12 weeks of active treatment with additional time for screening and follow-up assessments. Early termination from the study may occur under conditions such as withdrawal of consent, protocol non-compliance, adverse events requiring discontinuation, or at the discretion of the investigator if continuation is deemed not in the participant's best interest. The estimated recruitment start date is January 2026, with an estimated study completion date of February 2028.
Treatment
The experimental medication evaluated in this trial is **BP1.4979**, which contains the active substance **N-[4-[2-[4-(3-cyanophenyl)piperazin-1-yl]ethyl]cyclohexyl]-3-methoxypropanamide**. This investigational product is formulated as a **tablet** for **oral use**. The maximum daily dose is **40 mg**, with a maximum total dose of **3360 mg** administered over a treatment period of **12 weeks**. The sponsor product code for this compound is BP1.4979, and it is manufactured by BIOPROJET. The active substance is of chemical origin.
The comparator treatment consists of a matching **film-coated placebo tablet** designed to maintain the **double-blind** nature of the trial. The placebo is administered via **oral use** and follows the same dosing schedule as the active treatment, with a maximum daily dose equivalent of **40 mg** and a maximum total dose of **3360 mg** over the **12-week** treatment period. The placebo formulation contains no active pharmaceutical ingredient and serves as the control arm in this **parallel-group** study design to assess the efficacy and safety of BP1.4979 in adult participants with **obsessive compulsive disorder**.
Efficacy
The primary efficacy endpoint is the change in the total score on the **Yale-Brown Obsessive-Compulsive Scale Second Edition (YBOCS-II)** at end of treatment. Secondary efficacy endpoints include the change in total score of the YBOCS-II at visits 3 and 4, the change in total score of **Obsessive-Compulsive Inventory-Revised (OCI-R)** at visits 3, 4 and 5, the change in global functioning responses as assessed on the **Clinical Global Impressions – Change (CGI-C)** scale, and the change in total score of **Montgomery and Asberg Depression Rating Scale (MADRS)**. At screening and randomization, participants must have a current total YBOCS-II score of at least 22, with no more than 35% improvement or worsening in the score from screening to randomization visit.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Written informed consent obtained prior to any trial-related procedures.
- Male or female ≥18-75 years old.
- 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.
- 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.
- 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).
- 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.
- 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).
- 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.
- If required, participant must be insured by appropriate national health insurance system.
Exclusion Criteria
- 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.
- 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.
- Any history of Substance-Related and Addictive Disorders (excluding nicotine and caffeine).
- Regular (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.].
- 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).
- 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.
- Brain damage, or other cognitive impairment that would interfere with the capacity to participate in the trial and complete measures.
- 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].
- 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.
- 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.
- 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.
- Unstable/uncontrolled bipolar I or II disorder.
- 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.
- 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.
- 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.
- Concomitant prolactin-dependent tumour (e.g., pituitary tumour or breast cancer).
- Participants who had psychosurgery or have a Deep Brain Stimulation (DBS).
- Electroconvulsive therapy (ECT) or Transcranial Magnetic Stimulation (TMS) in the past 3 months.
- 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.
- Participant 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.
- History of hypersensitivity to any of the trial drug constituents.
- 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).
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Italy | Recruiting | 01 Jan 2026 | 12 |
 Poland | Recruiting | 01 Jan 2026 | 10 |
 Portugal | Recruiting | 01 Jan 2026 | 12 |
 Spain | Recruiting | 01 Jan 2026 | 20 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Matching film-coated placebo tablet | Placebo | N/A | ORAL USE | 40 | 12 | N/A |