Clinical trial to determine the efficacy and safety of AP707 in the treatment of Borderline Personality Disorder

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Apurano Pharmaceuticals GmbH

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2026-04-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Dose response

The primary objective of this trial is to show the efficacy of AP707 in Borderline Personality Disorder participants compared to placebo regarding the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) and the Borderline Symptom Scale for Borderline Personality Disorder (BSL-23).

Secondary objectives 14

1. To show the efficacy of AP707 in BPD participants regarding the ZAN-BPD;
2. To show the efficacy of AP707 in BPD participants regarding the BSL-23;
3. Evaluate the efficacy of AP707 in BPD participants regarding the Clinical Global Impression Severity Scale (CGI-S);
4. Evaluate the efficacy of AP707 in BPD participants regarding the Patient Global Impression of Change (PGI-C);
5. Evaluate the efficacy of AP707 in BPD participants regarding the State-Trait Anger Expression Inventory 2 (STAXI-2);
6. Evaluate the efficacy of AP707 in BPD participants regarding the Difficulties in Emotion Regulation Scale (DERS-36);
7. Evaluate the efficacy of AP707 in BPD participants regarding depression;
8. Evaluate the efficacy of AP707 in BPD participants regarding the State-Trait Anxiety Inventory (STAI);
9. Evaluate the efficacy of AP707 in BPD participants regarding impulsivity;
10. Evaluate the efficacy of AP707 in BPD participants regarding the interpersonal sector score of ZAN-BPD;
11. Evaluate the efficacy of AP707 in BPD participants regarding the cognitive sector score of ZAN-BPD;
12. Evaluate the efficacy of AP707 in BPD participants regarding the affective sector score of ZAN-BPD;
13. Evaluate the efficacy of AP707 in BPD participants regarding the NRS-Pain score;
14. Evaluate the efficacy of AP707 in BPD participants regarding rescue medication intake.

Conditions and MedDRA coding

Borderline personality disorder

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Signed and dated study informed consent forms, demonstrating willingness to comply with trial instructions;
2. Zanarini rating scale for borderline personality disorder (ZAN-BPD, 0-36) of ≥ 10 at screening;
3. Female and male participants aged 18 years or older at the time of informed consent signa-ture;
4. Participants with main diagnosis of borderline personality disorder (BPD) per Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
5. BPD was confirmed by structured interview for DSM-5 Personality Disorder (SCID-5-PD) at screening visit;
6. Stable dosage of psychiatric medication (e.g., antidepressants, mood stabilizers, antipsychotics) for at least 28 days prior to screening or no medication intake. This does not apply to pro re nata medication;
7. Participants commitment to use effective contraception methods (<1% failure rate) from screening to end of follow-up. This does not apply for persons of abstinence from sexual inter-course or non-childbearing potential (i.e. post-menopausal, surgically sterile). An effective contraception usually includes the use of a barrier method with another contraception method simultaneously;
8. Good command of German language, to fully understand the questionnaires;
9. Participants must have a smartphone on which the EDC application can be installed;

Exclusion criteria 18

1. Medical history of hypersensitivity or intolerance to the IMP or its ingredients or to ingredients of similar chemical structure;
2. Known intolerance to cannabinoids or cannabis products;
3. Known use of cannabis products within the last 28 days before screening or during the study;
4. Females who are currently pregnant or lactating or intend to become pregnant during the trial;
5. Participation in another clinical trial within the last four weeks prior to screening or the administration of another IMP within 5 half-lives before screening;
6. Participant is considered to belong to a vulnerable population (e.g. not capable of giving consent independently, imprisoned, other);
7. Known severe cardiovascular disease such as cardiac insufficiency (New York Heart Association Classification (NYHA) Class III-IV), acute myocardial infarction, any form of cardiomyopathy (not to be counted as exclusion criteria: hypertension, adjusted cardiac arrhythmias, recovered from infectious heart diseases);
8. Known liver disease or alanine aminotransferase (ALT, GPT) or aspartate aminotransferase (AST, GOT) or alkaline phosphatase (AP, ALP) level ≥ 2.5 x upper limit of normal (ULN) or bilirubin ≥ 1.5 x ULN at screening;
9. Known kidney disease or serum creatinine ≥ 1.5 x ULN or estimated glomerular filtration rate < 60 mL/min at screening;
10. Acute suicidality according to clinical judgement (based on psychopathological findings and C-SSRS interview);
11. Initiation or change in any type or frequency of psychotherapy within 3 months prior to screening. Exceptions: a) Participants with ongoing, stable outpatient psychotherapy > 3 months prior to screening (and intend to maintain the same frequency during the trial) could qualify as per clinical judgement of the investigator. b) Participants who completed inpatient therapy at least 14 days prior to the screening visit could qualify as per clinical judgement of the investigator.
12. Clinical diagnosis of paranoid, schizoid, schizotypal and acute severe substance use disorder according to DSM-5;
13. Lifetime diagnosis for schizophrenia spectrum and other psychotic disorders, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder as confirmed by the SCID-5-PD interview at the screening visit;
14. The intake of at least one of the following medications before and during the study: Clozapine, Carbamazepine, Valproic acid, St. John’s wort, grapefruit juice, constant benzodiazepine use. Exception: The therapy had been discontinued at least 21 days prior to screening and the discontinuation must have been independent of participation in the study;
15. Any psychiatric condition that, in the investigator's opinion, would prevent the participant from adhering to the protocol or completing the clinical trial per protocol;
16. Any clinically significant finding of the physical examination that would jeopardize the participant´s safety during the trial;
17. Participant is study investigator or personnel of a trial site, the sponsor or involved service providers and/or their immediate families (partner, spouse, parent, child, or sibling, whether biological or legally adopted);
18. An ECG QTc limit value of more than 450 milliseconds in men and an ECG QTc limit value of more than 470 milliseconds in women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. (i) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in ZAN-BPD total score at EoT;
2. (ii) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in BSL-23 total score at EoT.

Secondary endpoints 26

1. 1. a) Proportion of ZAN-BPD responders (i.e., participants with ≥30% ZAN-BPD total score reduction at EoT compared to baseline) (verum compared to pla-cebo)
2. 1. b) Proportion of ZAN-BPD responders (i.e., participants with ≥50% ZAN-BPD total score reduction at EoT compared to baseline) (verum compared to pla-cebo)
3. 1. c) Time to first response of participants who experienced ≥30% ZAN-BPD total score reduction at EoT compared to baseline (verum com-pared to placebo)
4. 1. d) Time to first response of participants who experienced ≥50% ZAN-BPD total score reduction at EoT compared to baseline (verum com-pared to placebo)
5. 2. a) Proportion of BSL-23 responders (i.e., participants with ≥30% BSL-23 total score reduction at EoT compared to baseline) (verum compared to pla-cebo)
6. 2. b) Proportion of BSL-23 responders (i.e., participants with ≥50% BSL-23 total score reduction at EoT compared to baseline) (verum compared to placebo)
7. 2. c) Time to first response of participants who experienced ≥30% BSL-23 total score reduction at EoT compared to baseline (verum compared to pla-cebo)
8. 2. d) Time to first response of participants who experienced ≥50% BSL-23 total score reduction at EoT compared to baseline (verum compared to placebo)
9. 3. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in CGI-S score at EoT (additionally: at V2, V3, …, V9)
10. 4. Proportion of participants per PGI-C score at EoT
11. 5. a) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAXI-2 (Trait-Anger) t-value at EoT
12. 5. b) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAXI-2 (Anger Expression-Out) t-value at EoT
13. 5. c) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAXI-2 (Anger Expression-In) t-value at EoT
14. 5. d) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAXI-2 (Anger Control) t-value at EoT
15. 6. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in DERS-36 total score at EoT
16. 7. a) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in Patient Health Questionnaire (PHQ-9) total score at EoT
17. 7. b) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in Montgomery-Åsberg Depression Rat-ing Scale (MADRS) total score at EoT
18. 8. a) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAI (State-Anxiety) score at EoT
19. 8. b) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAI (Trait-Anxiety) score at EoT
20. 9. a) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in Barratt Impulsiveness Scale 15 (BIS-15) total score at EoT
21. 9. b) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in impulsive sector score of ZAN-BPD at EoT
22. 10. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in interpersonal sector score of ZAN-BPD at EoT
23. 11. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in cognitive sector score of ZAN-BPD at EoT
24. 12. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in affective sector score of ZAN-BPD at EoT
25. 13. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in NRS-Pain score at EoT
26. 14. Number of participants with rescue medication over the course of the clinical trial and within periods: until Visit ≤ V2 (1 week), ≤ V3 (2 weeks), ≤ V4 (3 weeks), ≤ V5 (5 weeks), ≤ V6 (7 weeks), ≤ V7 (9 weeks), ≤ V8 (11 weeks), ≤ V9 (13 weeks), ≤ EoT (15 weeks), ≤ FU (18 weeks)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Apurano Pharmaceuticals GmbH

Sponsor organisation

Apurano Pharmaceuticals GmbH

Address

Birkerfeld 12, Lochham Lochham

City

Warngau

Postcode

83627

Country

Germany

Scientific contact point

Organisation

Apurano Pharmaceuticals GmbH

Contact name

Medical Affairs

Public contact point

Organisation

Apurano Pharmaceuticals GmbH

Contact name

Medical Affairs

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications