Clinical Trials Register

Summary
EudraCT Number:	2021-003700-41
Sponsor's Protocol Code Number:	77242113PSO2001
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:	2021-12-17
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

Spain - AEMPS

A.2

EudraCT number

2021-003700-41

A.3

Full title of the trial

A Phase 2b Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

Estudio en fase IIb, multicéntrico, aleatorizado, controlado con placebo y de determinación de la dosis para evaluar la eficacia y la seguridad de JNJ-77242113 para el tratamiento de la psoriasis en placas de moderada a grave

A.3.1

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

A Study to Investigate the Safety and Efficacy of Multiple Doses of JNJ-77242113 in Participants with Moderate to Severe Plaque Psoriasis

Estudio para investigar sobre la seguridad y la eficacia de múltiples dosis de JNJ-77242113 en pacientes con psoriasis en placas de moderada a grave

A.3.2

Name or abbreviated title of the trial where available

FRONTIER 1: Efficacy and Safety of JNJ-77242113 in Moderate to Severe Plaque Psoriasis

FRONTIER 1: Eficacia y seguridad de JNJ-77242113 en psoriasis en placas de moderada a grave

A.4.1

Sponsor's protocol code number

77242113PSO2001

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 and 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, S.A
B.5.2	Functional name of contact point	Global Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Paseo de las Doce Estrellas, 5-7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28042
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34650 93 95 53
B.5.6	E-mail	ccarrill@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-77242113
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.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	Not assigned
D.3.9.2	Current sponsor code	JNJ-77242113
D.3.9.3	Other descriptive name	PN-235, JNJ-77242113-AAJ
D.3.9.4	EV Substance Code	SUB235598
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	100
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	JNJ-77242113
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.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	Not assigned
D.3.9.2	Current sponsor code	JNJ-77242113
D.3.9.3	Other descriptive name	PN-235, JNJ-77242113-AAJ
D.3.9.4	EV Substance Code	SUB235598
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.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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Plaque Psoriasis

Psoriasis en placas

E.1.1.1

Medical condition in easily understood language

Plaque Psoriasis

Psoriasis en placas

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10071117
E.1.2	Term	Plaque psoriasis
E.1.2	System Organ Class	100000004858

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 dose response of JNJ-77242113 at Week 16 in participants with moderate-to-severe plaque psoriasis

Evaluar la respuesta a la dosis de JNJ-77242113 en la semana 16 en pacientes con psoriasis en placas de moderada a grave

E.2.2

Secondary objectives of the trial

- To characterize additional efficacy of JNJ-77242113 versus placebo in participants with moderate-to-severe plaque psoriasis
- To evaluate the effect of JNJ-77242113 treatment on patient-reported psoriasis severity versus placebo in participants with moderate-to-severe plaque psoriasis
- To evaluate the effect of JNJ-77242113 treatment on dermatology-specific health-related quality of life versus placebo in participants with moderate-to-severe plaque psoriasis
- To evaluate the effect of JNJ-77242113 treatment on general health-related quality of life versus placebo in participants with moderate-to-severe plaque psoriasis
- To assess the safety and tolerability of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis

- Caracterizar la eficacia adicional de JNJ-77242113 frente al placebo en pacientes con psoriasis en placas de moderada a grave
- Evaluar el efecto del tratamiento con JNJ-77242113 sobre la gravedad de la psoriasis notificada por el paciente frente al placebo en pacientes con psoriasis en placas de moderada a grave
- Evaluar el efecto del tratamiento con JNJ-77242113 sobre la calidad de vida asociada a la salud específica de la dermatología frente al placebo en pacientes con psoriasis en placas de moderada a grave
- Evaluar el efecto del tratamiento con JNJ-77242113 sobre la calidad de vida asociada a la salud general frente al placebo en pacientes con psoriasis en placas de moderada a grave
- Evaluar la seguridad y la tolerabilidad de JNJ-77242113 en pacientes con psoriasis en placas de moderada a grave

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

Clinical protocol, 17 November 2021, amendment 1. There will be four optional substudy collections for participants who consent (where local regulations permit): a pharmacogenomic blood sample, ex vivo cytokine release blood sample, skin biopsy, and photograph collection (lesional or lesional and full body).

Protocolo clínico, 17 de Noviembre de 2021, enmienda 1 .Se realizarán cuatro recogidas para el subestudio opcional en los pacientes que den su consentimiento (cuando la normativa local lo permita): una muestra de sangre para farmacogenómica, una muestra de sangre para la liberación de citocinas ex vivo, una biopsia cutánea y la obtención de fotografías (lesiones o cuerpo entero con lesiones).

E.3

Principal inclusion criteria

1. Male or female ≥18 years of age
2. Has a diagnosis of plaque psoriasis, with or without PsA, for at least 6 months prior to the first administration of study intervention
3. Has a total BSA ≥10% at screening and baseline.
4. Has a total PASI ≥12 at screening and baseline.
5. Has a total IGA ≥3 at screening and baseline.

1. Hombre o mujer ≥18 años
2. Tener un diagnóstico de psoriasis en placas, con o sin artritis psoriásica (APs), durante 6 meses como mínimo antes de la primera administración del tratamiento del estudio
3. Tener una BSA total ≥10 % en la selección y la visita basal
4. Tener un PASI total ≥12 en la selección y la visita basal
5. Tener una IGA total ≥3 en la selección y la visita basal
Por favor, refiérase a la sección 5.1 del protocolo para consultar todos los criterios de inclusión.

E.4

Principal exclusion criteria

1. Has a nonplaque form of psoriasis
2. Has current drug-induced psoriasis
3. Has previously received any other therapeutic agent directly targeted to IL-23
4. Has received any therapeutic agent directly targeted to IL-17 or IL-12/23 or has received anti-TNFα biologic therapy within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
5. Has received agents that modulate B cells within 26 weeks of the first administration of study intervention

1. Tener una forma de psoriasis no en placas.
2. Tener actualmente psoriasis inducida por fármacos.
3. Haber recibido previamente cualquier otro agente terapéutico dirigido directamente a la IL-23.
4. Haber recibido algún agente terapéutico dirigido directamente a la IL-17 o la IL-12/23 o haber recibido tratamiento biológico anti-TNFα en las 12 semanas o 5 semividas (lo que sea más largo) anteriores a la primera administración del tratamiento del estudio.
5. Haber recibido fármacos que modulan las células B en las 26 semanas anteriores a la primera administración del tratamiento del estudio.
Por favor, refiérase a la sección 5.2 del protocolo para consultar todos los criterios de exclusión.

E.5 End points

E.5.1

Primary end point(s)

Proportion of participants achieving PASI 75 (≥75% improvement from baseline in PASI)

Proporción de pacientes que logran un PASI 75 (≥75 % de mejora respecto a la visita basal en el PASI) en la semana 16

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

Semana 16

E.5.2

Secondary end point(s)

- Change from baseline in PASI total score
- Proportion of participants achieving PASI 90 (≥90% improvement from baseline in PASI)
- Proportion of participants achieving PASI 100 (100% improvement from baseline in PASI)
- Proportion of participants achieving an IGA score of cleared (0) or minimal (1)
- Proportion of participants achieving an IGA score of cleared (0)
- Change from baseline in BSA
- Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptoms scores
- Change from baseline in PSSD signs score
- Proportion of participants achieving PSSD symptoms score=0 among participants with a baseline symptoms score ≥1
- Proportion of participants achieving PSSD signs score=0 among participants with a baseline signs score ≥1
- Proportion of participants achieving a DLQI of 0 or 1 among participants with baseline DLQI score >1
- Change from baseline in domain scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
- Proportion of participants who achieve at least a 5-point improvement from baseline in each PROMIS-29 domain
- Frequency and type of AEs and SAEs

- Cambio respecto a la visita basal en la puntuación total del PASI
- Proporción de pacientes que logran un PASI 90 (≥90 % de mejora respecto a la visita basal en el PASI)
- Proporción de pacientes que logran un PASI 100 (100 % de mejora respecto a la visita basal en el PASI)
- Proporción de pacientes que logran una puntuación IGA de aclarada (0) o mínima (1)
- Proporción de pacientes que logran una puntuación IGA de aclarada (0)
- Cambio respecto a la visita basal en la BSA
- Cambio respecto a la visita basal en la puntuación de los síntomas del Diario de signos y síntomas de psoriasis (PSSD)
- Cambio respecto a la visita basal en la puntuación de los signos del PSSD
- Proporción de pacientes que logran una puntuación de los síntomas del PSSD = 0 entre los pacientes con una puntuación de los síntomas en la visita basal ≥1
- Proporción de pacientes que logran una puntuación de los signos del PSSD = 0 entre los pacientes con una puntuación de los signos en la visita basal ≥1
- Proporción de pacientes que logran un DLQI de 0 o 1 entre los pacientes con una puntuación del DLQI en la visita basal >1
- Cambio respecto a la visita basal en las puntuaciones de los dominios del Sistema de información de las mediciones de los resultados comunicados por el paciente (PROMIS-29)
- Proporción de pacientes que logran al menos una mejora de 5 puntos respecto a la visita basal en cada dominio de PROMIS-29
- Frecuencia y tipo de AA y AAG

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 16

Semana 16

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

Immunogenicity
Biomarkers

Inmunogenicidad
Biomarcadores

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

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

Canada

Czechia

Germany

Japan

Korea, Republic of

Poland

Spain

Taiwan

United Kingdom

United States

France

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

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:

216

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

119

F.4.2.2

In the whole clinical trial

240

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)

At the end of study treatment (Week 16), participants who meet all eligibility requirements outlined in the LTE protocol, (77242113PSO2002), will be offered the opportunity to enter the 36-week treatment LTE study. Further details about the LTE study design will be outlined in a separate protocol (772424113PSO2002).Please refer to Section 6.6 of the protocol (77242113PSO2001) for additional information.

Al final del tratamiento (semana 16) los pacientes elegibles según los requerimientos del protocolo de ALP (77242113PSO2002) tendrán la opción de ser incluidos en un estudio de ampliación a largo plazo (ALP) de 36 semanas de tratamiento. El diseño del estudio de la ALP se detallará en un protocolo específico (77242113PSO2002). Por favor, refiérase a la sección 6.6 del protocolo (77242113PSO2001) para más información.

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

2022-03-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-07

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

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