Clinical Trials Register

Summary
EudraCT Number:	2020-005503-40
Sponsor's Protocol Code Number:	CNTO1275JPA3001
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:	2021-08-31
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2020-005503-40

A.3

Full title of the trial

A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

“Estudio de fase 3 multicéntrico, abierto para evaluar la eficacia, farmacocinética, seguridad e inmunogenicidad del ustekinumab o guselkumab administrado por vía subcutánea en participantes pediátricos con artritis psoriásica juvenil activa (PSUMMIT-Jr)”

A.3.1

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

Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Estudio para evaluar la eficacia, farmacocinética, seguridad e inmunogenicidad del ustekinumab o guselkumab administrado por vía subcutánea en participantes pediátricos con artritis psoriásica juvenil activa

A.3.2

Name or abbreviated title of the trial where available

PSUMMIT-Jr

A.4.1

Sponsor's protocol code number

CNTO1275JPA3001

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/467/2020

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	Complejo Hospitalario Gregorio Marañón
B.5.2	Functional name of contact point	Dr. Juan Carlos Nieto
B.5.3	Address:
B.5.3.1	Street Address	Calle del Doctor Esquerdo, 46
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28009
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34637723549
B.5.6	E-mail	juancarlos.nietog@gmail.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	Yes
D.2.1.1.1	Trade name	STELARA®
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Ustekinumab
D.3.2	Product code	CNTO1275
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ustekinumab
D.3.9.2	Current sponsor code	CNTO1275
D.3.9.3	Other descriptive name	USTEKINUMAB
D.3.9.4	EV Substance Code	SUB27761
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal Antibody
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	Yes
D.2.1.1.1	Trade name	STELARA®
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Ustekinumab
D.3.2	Product code	CNTO1275
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ustekinumab
D.3.9.2	Current sponsor code	CNTO1275
D.3.9.3	Other descriptive name	USTEKINUMAB
D.3.9.4	EV Substance Code	SUB27761
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal Antibody
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	Guselkumab
D.3.2	Product code	CNTO1959
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Guselkumab
D.3.9.2	Current sponsor code	CNTO 1959
D.3.9.3	Other descriptive name	GUSELKUMAB
D.3.9.4	EV Substance Code	SUB179789
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal antibody
D.IMP: 4
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	Guselkumab
D.3.2	Product code	CNTO1959
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Guselkumab
D.3.9.2	Current sponsor code	CNTO 1959
D.3.9.3	Other descriptive name	GUSELKUMAB
D.3.9.4	EV Substance Code	SUB179789
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal antibody

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Juvenile Psoriatic Arthritis

Artritis Psoriásica Juvenil

E.1.1.1

Medical condition in easily understood language

Juvenile Psoriatic Arthritis

Artritis Psoriásica Juvenil

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10076674
E.1.2	Term	Juvenile psoriatic arthritis
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

- Evaluate PK of ustekinumab and guselkumab in jPsA
- Evaluate efficacy of ustekinumab and guselkumab in jPsA

- Evaluar la FC de ustekinumab y guselkumab en la jPsA
- Evaluar la eficacia de ustekinumab y guselkumab en la APsj

E.2.2

Secondary objectives of the trial

- Evaluate PK of ustekinumab and guselkumab in jPsA
- Evaluate efficacy of ustekinumab and guselkumab in jPsA
- Evaluate safety of ustekinumab and guselkumab in jPsA
- Evaluate immunogenicity of ustekinumab and guselkumab in jPsA

- Evaluar la FC de ustekinumab y guselkumab en la APsJ
- Evaluar la eficacia de ustekinumab y guselkumab en la APsJ
- Evaluar la seguridad de ustekinumab y guselkumab en la APsJ
- Evaluar la inmunogenia de ustekinumab y guselkumab en la APsJ

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. ≥5 to <18 years of age, inclusive.
2. Diagnosis of jPsA by Vancouver inclusion criteria, with exclusion of ERA. Diagnosis made ≥12 weeks prior to screening. Arthritis plus psoriasis, or arthritis plus ≥2 of the following: dactylitis, nail pits, family history of psioriasis in a first or second-degree relative, psoriasis-like rash.
3. Active disease in ≥3 joints at screening and at Week 0 (defined as swelling or loss of motion with pain and/or tenderness). Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint.
4. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant’s source documents and initialed by the investigator.
5. Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to not be clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator.

1. De ≥5 a <18 años de edad, esta inclusive.
2. Diagnóstico de APsJ según los criterios de inclusión de Vancouver, con exclusión de ARE. Diagnóstico realizado ≥12 semanas antes de la selección. Artritis más psoriasis o artritis más ≥2 de los siguientes: dactilitis, piqueteado ungueal, antecedentes familiares de psoriasis en un familiar de primer o segundo grado, erupción cutánea similar a la psoriasis.
3. Enfermedad activa en ≥3 articulaciones en la selección y en la semana 0 (definida como hinchazón o pérdida de movilidad acompañada de dolor o dolor a la palpación). La hinchazón por sí sola cumple los criterios de una articulación artrítica activa. En ausencia de hinchazón, la pérdida de movilidad acompañada de dolor o dolor a la palpación, o ambos (dolor y dolor a la palpación), cumplen los criterios de una articulación artrítica activa.
4. Médicamente estable de acuerdo con los antecedentes médicos, la exploración física y las constantes vitales realizadas en la selección. Cualquier anomalía debe ser coherente con la enfermedad subyacente en la población del estudio y esta determinación debe registrarse en los documentos originales del participante; el investigador debe incluir sus iniciales.
5. Médicamente estable de acuerdo con los análisis clínicos realizados en la selección. Si los resultados del panel de bioquímica sérica o de hematología están fuera de los intervalos de referencia normales, el participante solo puede incluirse si el investigador considera que las anomalías o desviaciones de lo normal no son clínicamente significativas o son apropiadas y razonables para la población en estudio. Esta determinación debe registrarse en los documentos originales del participante; el investigador debe incluir sus iniciales.

E.4

Principal exclusion criteria

1. Participants with enthesitis-related arthritis (ERA)
2. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy within the timeframe specified before the planned first dose of study intervention.
3. If participants were non-responders to previously received biologic treatment with an overlapping mechanism including guselkumab, ustekinumab, tildrakizumab (MK3222) and risankizumab (BI-655066). Prior non-response to an anti-TNFα inhibitor, an IL-17 inhibitor or a Janus kinase (JAK) inhibitor is not an exclusion. Patients who previously discontinued ustekinumab for intolerance may be enrolled into the guselkumab cohort. Patients who previously discontinued guselkumab due to intolerance may be enrolled into the ustekinumab cohort.
4. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or 5 half-lives (whichever is longer) before the planned first dose of either study intervention or is currently enrolled in an investigational study. Receipt of an investigational vaccine for COVID-19 is not an automatic exclusion criterion; discuss with medical monitor.
5. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening. An exception is made for participants currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of either study intervention (Section 5.1, Inclusion criterion 16.a of the study protocol).

1. Participantes con artritis relacionada con entesitis (ARE).
2. Haber tomado cualquier tratamiento prohibido según se indica en la Sección 6.8 “Tratamiento concomitante” en el plazo especificado anterior a la primera dosis programada del tratamiento del estudio.
3. Si los participantes no respondieron al tratamiento biológico recibido previamente con un mecanismo superpuesto, incluidos guselkumab, ustekinumab, tildrakizumab (MK3222) y risankizumab (BI-655066). La falta de respuesta previa a un inhibidor anti factor de necrosis tumoral α (anti-TNFα), a un inhibidor de IL-17 o a un inhibidor de la janocinasa (JAK) no es excluyente. Los pacientes que previamente interrumpieron el tratamiento con ustekinumab debido a una intolerancia podrían inscribirse en la cohorte de guselkumab. Los pacientes que previamente interrumpieron el tratamiento con guselkumab debido a una intolerancia podrían inscribirse en la cohorte de ustekinumab.
4. Haber recibido un tratamiento en investigación (incluidas vacunas en investigación) o haber utilizado un dispositivo médico invasivo en investigación en las 4 semanas o 5 semividas (lo que dure más) anteriores a la primera dosis programada de cualquiera de los tratamientos del estudio o estar actualmente inscrito en un estudio de investigación. Haber recibido una vacuna en investigación contra la COVID-19 no es un criterio de exclusión automático; se debe consultar con el supervisor médico.
5. Tener antecedentes de infección granulomatosa latente o activa, incluidos TB, histoplasmosis o coccidioidomicosis antes de la selección. Se hace una excepción con los participantes que actualmente estén recibiendo tratamiento para la TB latente sin indicios de TB activa o que tengan antecedentes de TB latente y documentación de haber completado el tratamiento adecuado para la TB latente en los 3 años anteriores a la primera administración de cualquiera de los tratamientos del estudio (Sección 5.1 “Inclusión”, criterio 16.a, del protocolo del estudio).

E.5 End points

E.5.1

Primary end point(s)

Ustekinumab
1. Observed steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 28 by baseline age groups.
2. Percentage of participants with jPsA achieving ACR Pedi 30 response at Week 24.

Guselkumab
1. Observed steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 28 by baseline age groups.
2. Percentage of participants with jPsA achieving ACR Pedi 30 response at Week 24.

Ustekinumab
1. Concentraciones mínimas observadas en estado estacionario y ABCee prevista por el modelo FC poblacional durante un intervalo de administración de 12 semanas en la semana 28 por grupos de edades iniciales.
2. Porcentaje de participantes con APsJ que logran la respuesta del índice pediátrico del Colegio Estadounidense de Reumatología (ACR Pedi) 30 en la semana 24.

Guselkumab
1. Concentraciones mínimas observadas en estado estacionario y ABCee prevista por el modelo FC poblacional durante un intervalo de administración (4 u 8 semanas) en la semana 28 por grupos de edades iniciales.
2. Porcentaje de participantes con APsJ que logran la respuesta del ACR Pedi 30 en la semana 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

Ustekinumab and Guselkumab
1: Week 28
2: Week 24

Ustekinumab y Guselkumab
1: Semana 28
2: Semana 24

E.5.2

Secondary end point(s)

PK
Ustekinumab
1. Observed steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 52 by baseline age groups
Guselkumab
1. Observed steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 52 by baseline age groups.
Efficacy
Ustekinumab
2. Proportions of participants achieving ACR Pedi 30 response at Weeks 4, 8, 12, 16, 24 and 52.
3. Proportions of participants achieving ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52.
4. Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24.
5. Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, 28 and 52.
6. PASI response between baseline and Week 24.
Guselkumab
2. Proportions of participants achieving ACR Pedi 30 response at Weeks 4, 8, 12, 16, 24, and 52.
3. Proportions of participants achieving ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52.
4. Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24.
5. Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, 28 and 52.
6. PASI response between baseline and Week 24.
Safety
Ustekinumab and Guselkumab
7. The occurrences and type of AEs, SAEs, and reasonably related AEs will be summarized.
Immunogenicity
Ustekinumab and Guselkumab
8. The overall incidence of antibodies to ustekinumab/guselkumab (including peak titers) through Week 68.

FC
Ustekinumab
1. Concentraciones mínimas observadas en estado estacionario y ABCee prevista por el modelo FC poblacional durante un intervalo de administración de 12 semanas en la semana 52 por grupos de edades iniciales.
Guselkumab
1. Concentraciones mínimas observadas en estado estacionario y ABCee prevista por el modelo FC poblacional durante un intervalo de administración (4 u 8 semanas) en la semana 52 por grupos de edades iniciales.
Eficacia
Ustekinumab
2. Proporciones de participantes que logran la respuesta del ACR Pedi 30 en las semanas 4, 8, 12, 16, 24 y 52.
3. Proporciones de participantes que logran la respuesta de los ACR Pedi 50 y 70 en las semanas 4, 8, 12, 16, 24 y 52.
4. Tiempo hasta la respuesta medido como el tiempo transcurrido hasta lograr la respuesta del ACR Pedi 30 desde el inicio hasta la semana 24.
5. Cambio con respecto al inicio en la puntuación de la actividad de la enfermedad de la artritis juvenil clínica (cJADAS) 10 y la puntuación de la actividad de la enfermedad de la artritis juvenil (JADAS) 10, 27 y 71 en las semanas 4, 8, 12, 16, 24, 28 y 52.
6. Respuesta del índice de gravedad y extensión de la psoriasis (PASI) entre el inicio y la semana 24.
Guselkumab
2. Proporciones de participantes que logran la respuesta del ACR Pedi 30 en las semanas 4, 8, 12, 16, 24 y 52.
3. Proporciones de participantes que logran la respuesta de los ACR Pedi 50 y 70 en las semanas 4, 8, 12, 16, 24 y 52.
4. Tiempo hasta la respuesta medido como el tiempo transcurrido hasta lograr la respuesta del ACR Pedi 30 desde el inicio hasta la semana 24.
5. Cambio con respecto al inicio en la cJADAS 10 y la JADAS 10, 27 y 71 en las semanas 4, 8, 12, 16, 24, 28 y 52.
6. Respuesta del PASI entre el inicio y la semana 24.
Seguridad
Ustekinumab y guselkumab
7. Se resumirán la incidencia y el tipo de AA, AAG y AA razonablemente relacionados.
Inmunogenicidad
Ustekinumab y guselkumab
8. La incidencia general de anticuerpos contra ustekinumab/guselkumab (incluidos los valores máximos) hasta la semana 68.

E.5.2.1

Timepoint(s) of evaluation of this end point

1: Week 52
2, 3: Weeks 4, 8, 12, 16, 24 and 52
4: from baseline through Week 24
5: Weeks 4, 8, 12, 16, 24, 28, and 52
6: baseline and Week 24
7, 8: from baseline through Week 68

1: semana 52.
2, 3: semanas 4, 8, 12, 16, 24 y 52.
4: desde el inicio hasta la semana 24.
5: semanas 4, 8, 12, 16, 24, 28 y 52.
6: inicio y semana 24.
7, 8: desde el inicio hasta la semana 68.

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

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

Argentina

United States

France

Poland

Sweden

Netherlands

Spain

Switzerland

Germany

Italy

Belgium

Denmark

Turkey

United Kingdom

E.8.7

Trial has a data monitoring committee

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

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Minor patients ≥5 to <18 years of age, inclusive

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

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)

All participants who complete the Week 52 evaluations will be eligible to enter a separate long term extension study (LTE) at Week 52 and continue on the same assigned treatment regimen. The participants may remain in the LTE until they have access to commercially available ustekinumab or guselkumab as an adult or up to 2 years after pediatric marketing authorization within their country of residence, or if the sponsor decides to discontinue the program, whichever situation occurs first.

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

2022-11-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-10-25

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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