Clinical Trials Register

Summary
EudraCT Number:	2020-000078-12
Sponsor's Protocol Code Number:	1402-0012
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-07-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2020-000078-12

A.3

Full title of the trial

A phase II randomized, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of 4 oral doses of BI 1358894 once daily over 12 week treatment period in patients with borderline personality disorder

Etude de phase II randomisée, en double aveugle, versus placebo, en groupes parallèles, évaluant l’efficacité et la sécurité de 4 doses du BI 1358894 prises par voie orale chaque jour pendant 12 semaines chez des patients atteints d’un Trouble de la Personnalité Borderline

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to test different doses of BI 1358894 and find out whether they reduce symptoms in people with borderline personality disorder

Etude visant à tester différentes doses du BI 1358894 et à déterminer si elles réduisent les symptômes chez les patients atteints d’un trouble de la personnalité borderline

A.4.1

Sponsor's protocol code number

1402-0012

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Boehringer Ingelheim France
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Boehringer-Ingelheim
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	CT Disclosure & Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+18002430127
B.5.5	Fax number	+18008217119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BI 1358894
D.3.2	Product code	BI 1358894
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	BI 1358894
D.3.9.3	Other descriptive name	BI 1358894
D.3.9.4	EV Substance Code	SUB189760
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BI 1358894
D.3.2	Product code	BI 1358894
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	BI 1358894
D.3.9.3	Other descriptive name	BI 1358894
D.3.9.4	EV Substance Code	SUB189760
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BI 1358894
D.3.2	Product code	BI 1358894
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	BI 1358894
D.3.9.3	Other descriptive name	BI 1358894
D.3.9.4	EV Substance Code	SUB189760
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

borderline personality disorder

Trouble de la personnalité borderline

E.1.1.1

Medical condition in easily understood language

borderline personality disorder

Trouble de la personnalité borderline

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10006033
E.1.2	Term	Borderline personality
E.1.2	System Organ Class	100000004873

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary study objectives are to demonstrate a non-flat curve, evaluate the dose-response
relationship and assess the treatment effect size.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

"MRI sub-study"
The objective of this sub-study is to explore structural and functional brain changes using MRI from baseline to week 10 in a subset of patients from the main study.

E.3

Principal inclusion criteria

- Patients meeting diagnostic criteria of BoPD per DSM-5 at screening visit, confirmed by SCID-5-PD.
- ZAN-BPD of ≥ 9 at screening (Visit 1) and randomization (Visit 2), with question #2 Affective Instability score of ≥2.
- Male or female patients, 18-65 years of age at the time of consent
- Women of childbearing potential (WOCBP)1 able and willing to use two methods of contraception, which include one highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1%, plus one barrier method.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

- Diagnostic établi d’un Trouble de la Personnalité Borderline (TPB) selon le DSM-5, confirmé à la visite d’inclusion par l’échelle SCID-5-PD.
- Hommes ou femmes, âgés de 18 à 65 ans au moment du consentement.
- Les femmes en âge de procréer1 capables et disposées à utiliser deux méthodes de contraception dont une méthode de contraception hautement efficace selon ICH M3 (R2) qui présentent un taux d’échec faible inférieur à 1% plus une barrière additionnelle.
- Consentement éclairé daté et signé en accord avec les ICH-GCP et la législation française avant l’admission dans l’étude.

E.4

Principal exclusion criteria

- Current diagnosis of paranoid, schizoid, schizotypal and antisocial personality disorders, as confirmed by SCID-5-PD at screening visit
- Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the SCID-5 at the screening visit.
- Any other mental disorder (in addition to those described in Exclusion 1 and 2) that is the primary focus of treatment in the last 6 months prior to randomization, as per the clinical judgement of the investigator.
- Inpatient stay or hospitalization due to worsening of BoPD within 3 months prior to randomization.
- Initiation or change in any type or frequency of psychotherapy (e.g. DBT, cognitive behavior therapy (CBT), Interpersonal therapy) for BoPD within the last 3 months prior to screening. Patients with ongoing, stable psychotherapy >3 months prior to Screening (and intend to maintain the same frequency during the study) may qualify as per clinical judgement of the investigator.
- Any ongoing use of psychotropic medications within 7 days prior to randomization or during the course of study (unless allowed per protocol, see Section 4.2.2.1). Investigators may use their clinical discretion to wash out (at least 3 half-lives of referenced medication) psychotropic medications during screening period. Such wash-out of ongoing psychotropic medication must complete at least 7 days prior to randomization.
- Further criteria apply.

- Diagnostic actuel de troubles de la personnalité paranoïde, schizoïde, schizotypique et antisocial, confirmé par le SCID-5-PD à la visite d’inclusion.
- Diagnostic de schizophrénie, trouble schizo-affectif, trouble schizophréniforme, trouble bipolaire 1, ou trouble délirant, confirmé par le SCID-5 à la visite d’inclusion.
- Diagnostic de tout autre trouble mental (en complément de ceux décrits aux critères d’exclusion 1 et 2) faisant l’objet d’un traitement dans les 6 mois précédant la randomisation, selon le jugement clinique de l’investigateur.
- Séjour ambulatoire ou hospitalisation pour aggravation du TPB dans les 3 mois précédant la randomisation.
- Patients ayant initié ou modifié la fréquence de leur psychothérapie (ex : TCC, TCD, thérapie interpersonnelle) pour leur TPB dans les 3 mois précédant la randomisation. Les patients ayant une psychothérapie stable et en cours > 3 mois avant l’inclusion (et qui ont l'intention de maintenir la même fréquence pendant l'étude) peuvent participer selon le jugement clinique de l'investigateur.
- Toute utilisation de traitements psychotropes dans les 7 jours précédant la randomisation ou pendant la durée de l’étude (sauf si autorisé par le protocole, voir section 4.2.2.1 du protocole). Les investigateurs devront s’assurer que le patient ne prenne plus ces traitements pendant la période d’inclusion (sevrage d’au moins 3 demies-vies du traitement référencé). Le sevrage des psychotropes devra être terminé dans les 7 jours précédant la randomisation.
- D'autres critères s'appliquent

E.5 End points

E.5.1

Primary end point(s)

1) Change from baseline in ZAN-BPD total score

1) Changement par rapport à la valeur initiale du score ZAN-PD

E.5.1.1

Timepoint(s) of evaluation of this end point

1) week 10

1) Semaine 10

E.5.2

Secondary end point(s)

1) Response defined as ≥30% ZAN-BPD reduction from baseline
2) Change from baseline in (DERS-16) total score
3) Change from baseline in STAI-S total score
4) Change from baseline in PHQ-9 total score
5) Change from baseline in CGI-S
6) Change from baseline in PGI-S

1) Réponse définie comme une réduction ≥ 30% de l’échelle ZAN-PD par rapport à la valeur initiale
2) Changement par rapport à la valeur initiale du DERS-16
4) Changement par rapport à la valeur initiale du PHQ-9
5) Changement par rapport à la valeur initiale du CGI-S
6) Changement par rapport à la valeur initiale du PGI-S

E.5.2.1

Timepoint(s) of evaluation of this end point

1) week 10
2) week 10
3) week 10
4) week 10
5) week 10
6) week 10

1) Semaine 10
2) Semaine 10
3) Semaine 10
4) Semaine 10
5) Semaine 10
6) Semaine 10

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Belgium

Bulgaria

Czech Republic

Denmark

France

Germany

Israel

Italy

Japan

Mexico

Poland

Romania

Spain

Sweden

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

340

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

184

F.4.2.2

In the whole clinical trial

355

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-09-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-01-25

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