Clinical Trials Register

Summary
EudraCT Number:	2020-005503-40
Sponsor's Protocol Code Number:	CNTO1275JPA3001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2021-10-19
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

Italy - Italian Medicines Agency

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 in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

Studio di fase 3 multicentrico, in aperto, per valutare l’efficacia, la farmacocinetica, la sicurezza e l’immunogenicità di ustekinumab somministrato per via sottocutanea in partecipanti pediatrici con artrite psoriasica giovanile attiva (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 in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Studio per valutare l'efficacia, la farmacocinetica, la sicurezza e l'immunogenicitàdi Ustekinumab somministrato per via sottocutanea in partecipanti pediatrici con artrite psoriasica giovanil

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 - 45 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 0.5 ML (90 MG/ML) 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG INTERNATIONAL N.V.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.9.1	CAS number	815610-63-0
D.3.9.2	Current sponsor code	CNTO1275
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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 - 90 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) 1 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 1 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG INTERNATIONAL N.V.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.9.1	CAS number	815610-63-0
D.3.9.2	Current sponsor code	CNTO1275
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Artrite psoriasica giovanile

E.1.1.1

Medical condition in easily understood language

Juvenile Psoriatic Arthritis

Artrite psoriasica giovanile

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 in jPsA
- Evaluate efficacy of ustekinumab in jPsA

- Valutare la farmacocinetica (PK) di ustekinumab nell’artrite psoriasica giovanile (jPsA)
- Valutare l’efficacia di ustekinumab nella jPsA

E.2.2

Secondary objectives of the trial

- Valutare la PK di ustekinumab nella jPsA
- Valutare l’efficacia di ustekinumab nella jPsA
- Valutare la sicurezza di ustekinumab nella jPsA
- Valutare l’immunogenicità di ustekinumab nella jPsA

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

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 prior to screening. Arthritis plus psoriasis, or arthritis plus at least 2 of the following: dactylitis, nail pits, family history 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, hematology, or urinalysis 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. Età compresa fra =5 e <18 anni inclusi.
2. Diagnosi di jPsA in base ai criteri di inclusione di Vancouver, con esclusione dell’artrite correlata a entesite (ERA). Diagnosi effettuata =3 mesi prima dello screening. Artrite più psoriasi o artrite più almeno 2 dei seguenti fattori: dattilite, pitting ungueale, anamnesi familiare di eruzione cutanea di primo o secondo grado simile a psoriasi.
3. Malattia in fase attiva in =3 articolazioni allo screening e alla Settimana 0 (definita come gonfiore O perdita di movimento con dolore e/o dolorabilità). Il gonfiore da solo soddisfa i criteri di un’articolazione artritica in fase attiva. In assenza di gonfiore, la perdita di movimento con dolore o dolorabilità o sia il dolore che la dolorabilità soddisfano i criteri di un’articolazione artritica in fase attiva.
4. Stabilità medica sulla base di esame obiettivo, anamnesi medica e valutazione dei segni vitali eseguiti allo screening. Qualsiasi anomalia deve essere coerente con la malattia sottostante nella popolazione di studio e questa determinazione deve essere registrata nei documenti originali del partecipante e siglata dallo sperimentatore.
5. Stabilità medica sulla base dei test clinici di laboratorio eseguiti allo screening. Se i risultati del pannello relativi a ematochimica sierica, ematologia o analisi delle urine non rientrano negli intervalli di riferimento normali, il partecipante può essere incluso solo se lo sperimentatore ritiene che le anomalie o le deviazioni dalla norma non siano clinicamente significative o siano appropriate e ragionevoli per la popolazione oggetto di studio. Tale determinazione deve essere registrata nei documenti originali del partecipante e siglata con le iniziali dallo sperimentatore.

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 of the study protocol before the planned first dose of study intervention.
3. If participants were nonresponders to previously received biologic treatment (excluding anti TNFas), including, but not limited to, guselkumab, secukinumab (AIN457), tildrakizumab (MK3222),
ixekizumab (LY2439821), brodalumab (AMG827), risankizumab (BI- 655066), or other investigative biologic treatments for PsA or psoriasis.
Prior nonresponse to an anti-TNFa inhibitor or to a Janus kinase (JAK) inhibitor is not an exclusion.
4. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 months before the planned first dose of 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, or have had a nontuberculous mycobacterial infection 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 study agent (Section 5.1, Inclusion criterion 16.a of the study protocol).

1. Partecipanti con artrite correlata a entesite (ERA)
2. Assunzione di eventuali terapie non consentite, come indicato nella Sezione 6.8, Terapia concomitante del protocollo dello studio prima della prima dose programmata di trattamento dello studio.
3. Mancata risposta dei partecipanti al trattamento biologico ricevuto in precedenza (esclusi gli anti-TNFa), compresi, a titolo esemplificativo ma non esaustivo, guselkumab, secukinumab (AIN457), tildrakizumab (MK3222), ixekizumab (LY2439821), brodalumab (AMG827), risankizumab (BI-655066) o altri trattamenti biologici sperimentali per PsA o psoriasi. La mancata risposta a un precedente inibitore anti-TNFa o a un inibitore della Janus chinasi (JAK) non è motivo di esclusione.
4. Pazienti che hanno ricevuto un trattamento sperimentale (compresi i vaccini sperimentali) o hanno utilizzato un dispositivo medico sperimentale invasivo nei 4 mesi precedenti la prima dose programmata di trattamento dello studio o attualmente arruolati in uno studio sperimentale. La somministrazione di un vaccino sperimentale contro il COVID-19 non rappresenta un criterio di esclusione automatico; discuterne con il responsabile del monitoraggio medico.
5. Anamnesi di infezione granulomatosa latente o attiva, tra cui TB, istoplasmosi o coccidioidomicosi, oppure manifestazione di infezione micobatterica non tubercolare prima dello screening. È stata fatta un’eccezione per i partecipanti che stanno attualmente ricevendo un trattamento per TB latente senza alcuna evidenza di TB attiva o che presentano un’anamnesi di TB latente e documentazione di completamento di un adeguato trattamento per TB latente nei 3 anni precedenti la prima somministrazione dell’agente dello studio (Sezione 5.1, Criterio di inclusione 16.a del protocollo dello studio).

E.5 End points

E.5.1

Primary end point(s)

1. Observed steady-state trough concentrations and population PK model-predicted area under the curve at steady-state over a 12-week dosing interval (AUCss) at Week 28.
2. Percentage of participants with jPsA achieving the JIA ACR 30 criteria at Week 24.

1. Osservazione di concentrazioni di valle allo stato stazionario e area sotto la curva prevista dal modello PK di popolazione allo stato stazionario nell’arco di un intervallo di somministrazione di 12 settimane (AUCss) alla Settimana 28.
2. Percentuale di partecipanti con jPsA che raggiungono i criteri ACR 30 per JIA alla Settimana 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

1: Week 28
2: Week 24

1: Settimana 28
2: Settimana 24

E.5.2

Secondary end point(s)

PK
1. Observed steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 52. Efficacy
2. Proportions of participants with JIA ACR 30 response at baseline and Weeks 4, 8, 12, 16, and 52.
3. Proportions of participants with JIA ACR 50 and 70 responses at baseline and Weeks 4, 8, 12, 16, 24, and 52.
4. Time to response measured using JIA ACR 30 from baseline through Week 24.
5. Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Weeks 4, 8, 12, 16, 28, and 52.
6. Change from baseline in Psoriasis Area Severity Index (PASI) at Week 24. Safety
7. The occurrences and type of AEs, serious adverse events (SAEs), and reasonably related AEs including injection-site reactions and infections will be summarized.
8. The number of participants with abnormal laboratory parameters (hematology and chemistry) based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grading will be summarized.
Immunogenicity
9. The overall incidence of antibodies to ustekinumab (including peak titers) through Week 68.

PK
1. Osservazione di concentrazioni di valle allo stato stazionario e AUCss prevista dal modello PK di popolazione nell’arco di un intervallo di somministrazione di 12 settimane alla Settimana 52. Efficacia
2. Percentuali di partecipanti con risposta ai criteri ACR 30 per JIA al basale e alle Settimane 4, 8, 12, 16 e 52.
3. Percentuali di partecipanti con risposta ai criteri ACR 50 e 70 per JIA al basale e alle Settimane 4, 8, 12, 16, 24 e 52.
4. Tempo alla risposta misurato in base al criterio ACR 30 per JIA dal basale alla Settimana 24.
5. Variazione rispetto al basale nel punteggio di attività della malattia da artrite giovanile (JADAS) alle Settimane 4, 8, 12, 16, 28 e 52.
6. Variazione rispetto al basale nell’Indice di estensione e gravità della psoriasi (PASI) alla Settimana 24. Sicurezza
7. Verranno riassunti gli eventi e il tipo di EA, eventi avversi gravi (SAE) e gli EA ragionevolmente correlati, comprese le reazioni e le infezioni nel sito di iniezione.
8. Verrà riassunto il numero di partecipanti con parametri di laboratorio anomali (ematologia e chimica) in base alla classificazione di tossicità secondo i Criteri comuni di terminologia per gli eventi avversi del National Cancer Institute (NCI-CTCAE). Immunogenicità
9. Incidenza complessiva di anticorpi anti-ustekinumab (compresi i titoli di picco) fino alla Settimana 68.

E.5.2.1

Timepoint(s) of evaluation of this end point

1: Week 52
2: baseline and Weeks 4, 8, 12, 16, and 52
3: baseline and Weeks 4, 8, 12, 16, 24, and 52
4: from baseline through Week 24
5: Weeks 4, 8, 12, 16, 28, and 52
6: Week 24
7, 8, 9: from baseline through Week 68

1: Settimana 52
2: Basale e Settimane 4, 8, 12, 16 e 52
3: Basale e Settimane 4, 8, 12, 16, 24 e 52
4: Dal basale alla Settimana 24
5: Settimane 4, 8, 12, 16, 28 e 52
6: Settimana 24
7, 8, 9: Dal basale alla Settimana 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

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

Information not present in EudraCT

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

Turkey

United States

France

Germany

Italy

Spain

Argentina

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.1.1.1

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

Minori di età compresa tra 5 e 18 anni di età inclusi

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 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.

I partecipanti che completano le valutazioni della settimana 52 saranno idonei per entrare in uno studio di estensione a lungo termine (LTE) separato alla settimana 52 e continuare con lo stesso regime di trattamento assegnato. I partecipanti possono rimanere nell'LTE fino a quando non hanno accesso a ustekinumab disponibile in commercio da adulti o fino a 2 anni dopo l'autorizzazione all'immissione in commercio pediatrica nel loro paese di residenza, o se lo sponsor interrrompe il programma.

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

2022-09-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Other

Date of Ethics Committee Opinion

2022-11-21

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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