Clinical Trials Register

Summary
EudraCT Number:	2020-005503-40
Sponsor's Protocol Code Number:	CNTO1275JPA3001
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2023-04-13
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

Poland - Office for Medicinal Products

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)

Wieloośrodkowe, prowadzone metodą otwartej próby badanie fazy III, oceniające skuteczność, farmakokinetykę, bezpieczeństwo stosowania i immunogenność ustekinumabu lub guselkumabu podawanego podskórnie u uczestników pediatrycznych z czynną postacią łuszczycowego młodzieńczego zapalenia stawów (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

Badanie oceniające skuteczność, farmakokinetykę, bezpieczeństwo i immunogenność podskórnie podawanego ustekinumabu lub guselkumabu u dzieci i młodzieży z czynnym młodzieńczym łuszczycowym zapaleniem stawów

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	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	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

Młodzieńcze łuszczycowe zapalenie stawów

E.1.1.1

Medical condition in easily understood language

Juvenile Psoriatic Arthritis

Młodzieńcze łuszczycowe zapalenie stawów

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

- Ocena PK ustekinumabu i guselkumabu w młodzieńczym łuszczycowym zapaleniu stawów
- Ocena skuteczności ustekinumabu i guselkumabu w młodzieńczym łuszczycowym zapaleniu stawów

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

- Ocena PK ustekinumabu i guselkumabu w młodzieńczym łuszczycowym zapaleniu stawów
- Ocena skuteczności ustekinumabu i guselkumabu w młodzieńczym łuszczycowym zapaleniu stawów
- Ocena bezpieczeństwa stosowania ustekinumabu i guselkumabu w młodzieńczym łuszczycowym zapaleniu stawów
- Ocena immunogenności ustekinumabu i guselkumabu w młodzieńczym łuszczycowym zapaleniu stawów

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 ≥3 months (ie. 90 days) 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. ≥5 do <18 lat włącznie.
2. Rozpoznanie młodzieńczego łuszczycowego zapalenia stawów według kryteriów włączenia z Vancouver, z wykluczeniem zapalenia stawów związanego z zapaleniem przyczepów ścięgnistych. Diagnoza postawiona ≥3 miesiące (tj. 90 dni) przed badaniem przesiewowym. Zapalenie stawów plus łuszczyca lub zapalenie stawów plus ≥2 z następujących objawów: zapalenie palców, wżery w paznokciach, rodzinne występowanie łuszczycy u krewnego pierwszego lub drugiego stopnia, wysypka łuszczycopodobna.
3. Aktywna choroba w ≥3 stawach w czasie badania przesiewowego i w Tygodniu 0. (zdefiniowana jako obrzęk lub utrata ruchu z bólem i/lub tkliwością). Sam obrzęk spełnia kryteria aktywnego stawu artretycznego. W przypadku braku obrzęku, utrata ruchu z bólem lub tkliwością lub zarówno ból jak i tkliwość spełniają kryteria aktywnego stawu artretycznego.
4. Stabilny medycznie na podstawie badania fizycznego, historii choroby i parametrów życiowych wykonanych podczas badania przesiewowego. Wszelkie nieprawidłowości muszą być zgodne z chorobą podstawową w populacji badanej, a ustalenie to musi być odnotowane w dokumentach źródłowych uczestnika i parafowane przez badacza.
5. Stabilny medycznie na podstawie klinicznych badań laboratoryjnych wykonanych podczas badania przesiewowego. Jeśli wyniki biochemiczne panelu surowicy lub hematologia są poza normalnymi zakresami referencyjnymi, uczestnik może zostać włączony do badania tylko wtedy, gdy badacz uzna, że nieprawidłowości lub odchylenia od normy nie są istotne klinicznie lub są odpowiednie i uzasadnione dla badanej populacji. Ustalenie to musi być odnotowane w dokumentach źródłowych uczestnika i parafowane przez badacza.

E.4

Principal exclusion criteria

1. Participants with enthesitis-related arthritis (ERA; see definition in
Appendix 17 of the study protocol)
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 IL-23
blockers including guselkumab, 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.
Participants who previously discontinued ustekinumab for intolerance or
inadequate response may be enrolled into the guselkumab cohort.
Patients who previously discontinued guselkumab due to intolerance
may be enrolled into the ustekinumab cohort. Participants who
previously discontinued tildrakizumab or risankizumab due to
intolerance may be enrolled into either 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 another study
using an investigational intervention or procedure. 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 prior to the first administration of either study intervention (Section 5.2, Exclusion criterion 14b of the study protocol).

1. Uczestnicy z zapaleniem stawów związanym z zapaleniem przyczepów ścięgnistych (ang. enthesitis-related arthritis, ERA; patrz definicja w Załączniku 17 protokołu badania)
2. Przyjmowanie wszelkich niedozwolonych terapii, o których mowa w punkcie 6.8, terapia towarzysząca, w określonych ramach czasowych przed planowaną pierwszą dawką leczenia stosowanego w badaniu.
3. Jeśli uczestnicy nie odpowiadali na wcześniej otrzymywane leczenie blokerami IL-23, w tym guselkumab, tildrakizumab (MK3222) i risankizumab (BI-655066). Wcześniejszy brak odpowiedzi na inhibitor anty-TNFα, inhibitor IL-17 lub inhibitor kinazy Janusowej (JAK) nie stanowi wykluczenia. Uczestnicy, którzy wcześniej przerwali stosowanie ustekinumabu z powodu nietolerancji lub niedostatecznej odpowiedzi, mogą zostać włączeni do kohorty guselkumabu. Pacjenci, którzy wcześniej przerwali stosowanie guselkumabu z powodu nietolerancji, mogą zostać włączeni do kohorty ustekinumabu. Uczestnicy, którzy wcześniej przerwali stosowanie tildrakizumabu lub risankizumabu z powodu nietolerancji, mogą zostać włączeni do którejkolwiek z kohort.
4. Otrzymanie leczenie stosowanego w badaniu (w tym badane szczepionki) lub użycie inwazyjnego badanego wyrobu medycznego w ciągu 4 tygodni lub 5 okresów półtrwania (w zależności od tego, który z nich jest dłuższy) przed planowaną pierwszą dawką któregokolwiek leczenia stosowanego w badaniu lub jest obecne włączenie do innego badania z zastosowaniem eksperymentalnego leczenia lub procedury. Otrzymanie badanej szczepionki dla COVID-19 nie jest automatycznym kryterium wykluczenia; omówić z monitorem medycznym.
5. Przed badaniami przesiewowymi występowało utajone lub aktywne zakażenie ziarniniakowe, w tym gruźlica, histoplazmoza lub kokcydioidomikoza. Wyjątek stanowią uczestnicy, którzy są obecnie leczeni z powodu utajonej gruźlicy bez dowodów na istnienie aktywnej gruźlicy lub którzy mają utajoną gruźlicę w wywiadzie i dokumentację ukończenia odpowiedniego leczenia utajonej gruźlicy przed pierwszym podaniem któregokolwiek leczenia stosowanego w badaniu (sekcja 5.2, kryterium wyłączenia 14b protokołu badania).

E.5 End points

E.5.1

Primary end point(s)

Ustekinumab
1. Steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 28 by baseline age groups.
2. ACR Pedi 30 response at Week 24.

Guselkumab
1. 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. ACR Pedi 30 response at Week 24.

Ustekinumab
1. . Obserwowane stężenia końcowe w stanie stacjonarnym i przewidywane przez model PK populacji wartości AUCss w 12-tygodniowej przerwie w dawkowaniu w tygodniu 28. w zależności od wyjściowych grup wiekowych.
2. Odpowiedź wg ACR Pedi 30 w tygodniu 24.
Guselkumab
1. Obserwowane stężenia końcowe w stanie stacjonarnym i przewidywane przez model PK populacji wartości AUCss w przedziale dawkowania (4 lub 8 tygodni) w tygodniu 28. w zależności od wyjściowych grup wiekowych.
2. Odpowiedź wg ACR Pedi 30 w tygodniu 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

Ustekinumab and Guselkumab
1: Week 28
2: Week 24

Ustekinumab i Guselkumab
1: Tydzień 28
2: Tydzień 24

E.5.2

Secondary end point(s)

Ustekinumab
1. Steady-state trough concentrations and population PK modelpredicted
AUCss over a 12-week dosing interval at Week 52 by baseline
age groups
Guselkumab
1. Steady-state trough concentrations and population PK modelpredicted
AUCss over a dosing interval (4 or 8 weeks) at Week 52 by
baseline age groups.
Efficacy
Ustekinumab
2. ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52.
3. 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, and 52.
6. Change from baseline in PASI score at Week 24 among the
participants with ≥3% BSA psoriatic involvement and a PGA psoriasis
score of ≥2 (mild) at baseline.
Guselkumab
2. ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52.
3. 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, and 52.
6. Change from baseline in PASI score at Week 24 among the
participants with ≥3% BSA psoriatic involvement and a PGA psoriasis
score of ≥2 (mild) at baseline.
Safety
Ustekinumab and Guselkumab
7. The occurrences and type of AEs, SAEs, and reasonably related AEs.
Immunogenicity
Ustekinumab and Guselkumab
8. The incidence of antibodies to ustekinumab/guselkumab (including
peak titers) through Week 52 and Week 68.

PK
Ustekinumab
1. Obserwowane stężenia końcowe w stanie stacjonarnym i PK w populacji
przewidywane przez model AUCss w 12-tygodniowej przerwie w dawkowaniu w tygodniu 52. w zależności od wyjściowych grup wiekowych
Guselkumab
1. Obserwowane stężenia końcowe w stanie stacjonarnym i przewidywane przez model PK populacji wartości AUCss w przedziale dawkowania (4 lub 8 tygodni) w tygodniu 52. w zależności od wyjściowych grup wiekowych.

Skuteczność
Ustekinumab
2. Odpowiedź ACR Pedi 30 w tygodniach
4., 8., 12., 16., 24. i 52.
3. Odpowiedzi ACR Pedi 50 i 70 w tygodniach 4., 8., 12., 16., 24. i 52.
4. Czas do odpowiedzi mierzony jako czas do osiągnięcia ACR Pedi 30 od linii podstawowej do tygodnia 24.
5. Zmiana od punktu wyjściowego w cJADAS 10, JADAS 10, 27 i 71 w tygodniach 4., 8., 12., 16., 24. i 52.
6. Zmiana w ocenie PASI między wartością wyjściową a tygodniem 24. wśród uczestników z zajęciem łuszczycą wynoszącym ≥3% BSA i wynikiem w skali PGA w łuszczycy wynoszącym ≥2 (łagodny) w punkcie wyjściowym.
Guselkumab
2. Odpowiedź ACR Pedi 30 w tygodniach
4., 8., 12., 16., 24. i 52.
3. Odpowiedzi ACR Pedi 50 i 70 w tygodniach 4., 8., 12., 16., 24. i 52.
4. Czas do odpowiedzi mierzony jako czas do osiągnięcia ACR Pedi 30 od linii podstawowej do tygodnia 24.
5. Zmiana od linii podstawowej w cJADAS 10, JADAS 10, 27 i 71 w tygodniach 4., 8., 12., 16., 24. i 52.
6.Zmiana w ocenie PASI między wartością wyjściową a tygodniem 24. wśród uczestników z zajęciem łuszczycą wynoszącym ≥3% BSA i wynikiem w skali PGA w łuszczycy wynoszącym ≥2 (łagodny) w punkcie wyjściowym.

Bezpieczeństwo
Ustekinumab i guselkumab
7. Występowanie i rodzaj ZN, CZN i racjonalnie powiązanych ZN.
Immunogenność
Ustekinumab i guselkumab
8. Ogólna częstość występowania przeciwciał przeciwko ustekinumabowi/guselkumabowi (w tym miana szczytowe) do tygodnia 52 i tygodnia 68.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

1: Tydzień 52
2: Tygodnie 4, 8, 12, 16 i 52
3: Tygodnie 4, 8, 12, 16, 24 i 52
4: od wizyty początkowej do tygodnia 24
5: Tygodnie 4, 8, 12, 16, 24 i 52
6: wizyta początkowa i tydzień 24
7, 8: od wizyty początkowej do tygodnia 52 i tygodnia 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 Kingdom

United States

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Türkiye

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

2023-07-02

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status

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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:
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