Clinical Trials Register

Summary
EudraCT Number:	2021-004790-31
Sponsor's Protocol Code Number:	55308942BIP2001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-03-17
Trial 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-004790-31

A.3

Full title of the trial

A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression

Estudio aleatorizado, estratificado, doble ciego y controlado con placebo para investigar la eficacia, la seguridad y la tolerabilidad de JNJ-55308942 en el tratamiento de la depresión bipolar

A.3.1

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

A Clinical Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression

Estudio para analizar la eficacia, la seguridad y la tolerabilidad de JNJ-55308942 en el tratamiento de la depresión bipolar

A.4.1

Sponsor's protocol code number

55308942BIP2001

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	Janssen-Cilag International NV
B.1.3.4	Country	Belgium
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	Janssen Research & Development, LLC
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag International NV
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333CM
B.5.3.4	Country	Netherlands
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	JNJ-55308942
D.3.2	Product code	JNJ-55308942
D.3.4	Pharmaceutical form	Capsule
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.3.8	INN - Proposed INN	Not assigned
D.3.9.1	CAS number	2166558-11-6
D.3.9.2	Current sponsor code	JNJ-55308942
D.3.9.3	Other descriptive name	JNJ-55308942-AAA
D.3.9.4	EV Substance Code	SUB189968
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	Capsule
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

Bipolar Depression

Depresión Bipolar

E.1.1.1

Medical condition in easily understood language

Depression

Depresión

E.1.1.2

Therapeutic area

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

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	10004936
E.1.2	Term	Bipolar depression
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

To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorders (BD) in a major depressive episode (MDE) at Week 6.

Evaluar la eficacia de JNJ-55308942 en comparación con el placebo en los síntomas de depresión de pacientes con TB en un episodio depresivo mayor (EDM) en la semana 6.

E.2.2

Secondary objectives of the trial

Secondary Objectives of Special Interest are:
1. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of anhedonia
2. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with BD who are heterozygous or homozygous for a P2X7 GoF SNP biomarker (genetic subgroup analysis)
3. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with BD type I or BD type II (diagnosis subgroup analysis)
4. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in subgroups of patients with specific biomarker profiles (biomarker subgroup analysis)
5. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in a subgroup of patients with messenger ribonucleic acid (mRNA) transcript levels at baseline that exceed the median level for both P2RX7 and IL-1β

1. Evaluar la eficacia de JNJ-55308942 en comparación con el placebo en los síntomas de anhedonia.
2. Evaluar la eficacia de JNJ-55308942 en comparación con el placebo en los síntomas de depresión en pacientes con TB que sean heterocigotos u homocigotos para el polimorfismo de nucleótido único (SNP) de ganancia de función (GoF) en rs1718119 de P2X7 (análisis de subgrupos genéticos).
3. Evaluar la eficacia de JNJ-55308942 en comparación con el placebo en los síntomas de depresión en pacientes con TB de tipo I o II (análisis de subgrupos de diagnóstico)
4. Evaluar la eficacia de JNJ-55308942 en comparación con el placebo en los síntomas de depresión en subgrupos de pacientes con perfiles
de biomarcadores específicos (análisis de subgrupos de biomarcadores)
5. Evaluar la eficacia de JNJ-55308942 en comparación con el placebo en los síntomas de depresión en un subgrupo de pacientes con niveles
de transcripción de ácido ribonucleico mensajero (ARNm) (más información en el Protocolo)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Each potential participant must satisfy all of the following criteria to be enrolled in the study:

Age
1. Any gender, 18 to 64 years of age, inclusive.

Type of Participant and Disease Characteristic
2. Presence of one or two copies of a GoF SNP biomarker in the P2RX7 gene.
3. Have a primary DSM-5 diagnosis of BD (Type I or II) without psychotic features, as confirmed by the MINI.
4. Must be experiencing an MDE
5. If currently taking lithium, valproic acid, or lamotrigine mood stabilizer therapy, must have been on a stable dose for at least the 4 weeks prior to screening.
6. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening.
7. Medically stable on the basis of clinical laboratory tests performed at screening.

Please refer to protocol for full inclusion criteria.

Para ser reclutados en el estudio, los posibles pacientes deberán cumplir los criterios siguientes:
Edad
1. Cualquier género, de 18 a 64 años, ambos inclusive.

Tipo de paciente y características de la enfermedad
2. Presencia de una o dos copias del alelo GoF A en rs1718119 (debe ser GA o AA en el nucleótido 1042; Ala348Thr) en el gen P2RX7.
3. Tener un diagnóstico primario DSM-5 de TB (tipo I o II) sin características psicóticas, según lo confirmado por la MINI.
4. Estar experimentando un EDM.
5. Si actualmente toma litio, ácido valproico o un tratamiento estabilizador del estado de ánimo con lamotrigina, debe haber estado tomando una dosis estable durante al menos las 4 semanas anteriores a la selección.
6. Ser estable desde el punto de vista médico de acuerdo con la exploración física, la historia clínica y las constantes vitales en el momento de la selección.
7. Ser estable desde el punto de vista médico de acuerdo con las pruebas analíticas clínicas realizadas en la selección.

E.4

Principal exclusion criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study:

Medical Conditions
1. Presence of two copies of a first LoF SNP biomarker, and/or has one or two copies of a second LoF SNP biomarker in the P2RX7 gene.
2. Based on the MINI (with Borderline Personality Disorder module) and clinical discretion, has a current DSM-5 diagnosis of:
• borderline personality disorder
• antisocial personality disorder
• eating disorder
• suicide behavior disorder
• ≥ 4 episodes of mood disturbances (e.g., mania, hypomania, depressed, dysthymia, or hypomania) within the past 12 months
• any psychotic disorder
3. Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI.
4. A YMRS of >12.

Please refer to protocol for full exclusion criteria.

No podrán participar en el estudio los posibles pacientes que cumplan alguno de los siguientes criterios:
Afecciones médicas:
1. Presencia de dos copias del alelo LoF C en rs3751143 (es decir, con CC en el nucleótido 1487) o una o más copias del alelo LoF A en rs1653624 (es decir, con AA o AT en el nucleótido 1703) en el gen P2RX7.
2. Según la MINI (con módulo de trastorno límite de la personalidad) y el criterio clínico, tener un diagnóstico actual según DSM-5 de:
- trastorno límite de la personalidad
- trastorno de personalidad antisocial
- trastorno alimenticio
- trastorno de conducta suicida
- mayor/igual 4 episodios de alteraciones del estado de ánimo (p. ej., manía, hipomanía, depresión, distimia o hipomanía) en los últimos 12 meses
- cualquier trastorno psicótico
3. Cumplir actualmente los criterios de DSM-5 para episodios maniacos (EM) en la MINI.
4. Una puntuación en YMRS mayor de 12.
(más información en el Protocolo)

E.5 End points

E.5.1

Primary end point(s)

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline.

Cambios en la Escala de valoración de la depresión de Montgomery-Åsberg (MADRS), respecto la puntuación del periodo de referencia.

E.5.1.1

Timepoint(s) of evaluation of this end point

At Week 6

Semana 6

E.5.2

Secondary end point(s)

Secondary endpoints of Special Interest:
1. Change in Dimensional Anhedonia Rating Scale (DARS) total score from baseline
2. Change in MADRS total score from baseline

Other secondary endpoints:
3. Vital signs, clinical labs, AEs, ECG, Young Mania Rating Scale (YMRS) score, Columbia Suicide Severity Rating Scale (C-SSRS) score
4. CGI-S
5. Plasma concentrations of JNJ-55308942
6.Self-rated outcomes
7. Response and remission rates

Objetivos secundarios de especial interés:
1. Cambio en la puntuación total de la Escala de la Evaluación Dimensional de la Anhedonia (EEDA) respecto al momento de referencia en la semana 6.
2. Cambio en la puntuación total de la Escala de valoración de la depresión de MontgomeryÅsberg (MADRS)

Otros objetivos secundarios:
3. Constantes vitales, pruebas analíticas clínicas, acontecimientos adversos, ECG, puntuación en la Escala de Young para la evaluación de la manía
(YMRS), puntuación en la Escala Columbia para evaluar el riesgo de suicidio (C-SSRS).
4. CGI-S
5. Concentraciones plasmáticas de JNJ-55308942.
6. Capacidad para participar en funciones y actividades sociales.
7. Valores de respuesta y remisión.

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 2 and 7: At week 6
3. Throughout the study
4 and 5. Day 1 (D1), D8, D15, D29 and D43
6. D1, D8, D15, D22, D29, D36 and D43

1, 2 y 7: en la semana 6
3: A lo largo de todo el ensayo
4 y 5: en el Día 1 (D1), D8, D15, D29 y D43
6: D1, D8, D15, D22, D29, D36 y D43

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tolerabilidad

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

Yes

E.8.1.7.1

Other trial design description

Estratificado, estudio multicéntrico

Stratified, multicenter study

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

Yes

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

Russian Federation

Ukraine

United States

Poland

Spain

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

Última visita del último paciente

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

E.8.9.2

In all countries concerned by the trial days

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:

164

F.1.3

Elderly (>=65 years)

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

F.4.2.2

In the whole clinical trial

164

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

2022-05-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-04-25

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials