Clinical Trials Register

Summary
EudraCT Number:	2019-001868-30
Sponsor's Protocol Code Number:	LP0160-1396
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-01-21
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-001868-30

A.3

Full title of the trial

A phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adolescent subjects (12–17 years of age) with moderate-to-severe plaque psoriasis

Uno studio di fase 3, randomizzato, in doppio cieco, multicentrico per valutare l'efficacia, la sicurezza e la tollerabilità del trattamento con brodalumab rispetto al placebo (in cieco) e all'ustekinumab (in aperto) in soggetti adolescenti (12-17 anni) con psoriasi a placche da moderata a grave

A.3.1

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

Efficacy and safety of brodalumab in adolescents from 12 to 17 years of age with moderate-to-severe plaque psoriasis

Efficacia e sicurezza di brodalumab negli adolescenti dai 12 ai 17 anni di età con psoriasi a placche da moderata a grave

A.3.2

Name or abbreviated title of the trial where available

EMBRACE 1

A.4.1

Sponsor's protocol code number

LP0160-1396

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/189/2018

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	LEO PHARMA A/S
B.1.3.4	Country	Denmark
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	LEO Pharma A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LEO Pharma A/S
B.5.2	Functional name of contact point	Global Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Industriparken 55
B.5.3.2	Town/ city	Ballerup
B.5.3.3	Post code	2750
B.5.3.4	Country	Denmark
B.5.4	Telephone number	44945888
B.5.6	E-mail	raleodk@leo-pharma.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	Kyntheum 210 mg solution for injection in pre-filled syringe
D.2.1.1.2	Name of the Marketing Authorisation holder	LEO Pharma A/S
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	Kyntheum (brodalumab)
D.3.2	Product code	[-]
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	BRODALUMAB
D.3.9.1	CAS number	1174395-19-7
D.3.9.2	Current sponsor code	Brodalumab
D.3.9.4	EV Substance Code	SUB180076
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	210
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	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	Yes
D.2.1.1.1	Trade name	Kyntheum
D.2.1.1.2	Name of the Marketing Authorisation holder	LEO Pharma A/S
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	brodalumab 140 mg
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Yes
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	BRODALUMAB
D.3.9.1	CAS number	1174395-19-7
D.3.9.2	Current sponsor code	BRODALUMAB
D.3.9.4	EV Substance Code	SUB180076
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	140
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	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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 solution for injection
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	-
D.3.2	Product code	[-]
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	-
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	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2259
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	-
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	equal
D.3.10.3	Concentration number	90
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	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: 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	Yes
D.2.1.1.1	Trade name	diTekiBooster, suspension for injection in pre-filled syringe
D.2.1.1.2	Name of the Marketing Authorisation holder	AJ Vaccines A/S
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	-
D.3.2	Product code	[-]
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphtheria, tetanus and pertussis
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR, COMPONENT) VACCINE (ADSORBED)
D.3.9.4	EV Substance Code	SUB11911MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphtheria, tetanus and pertussis
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR, COMPONENT) VACCINE (ADSORBED)
D.3.9.4	EV Substance Code	SUB11911MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphtheria, tetanus and pertussis
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR, COMPONENT) VACCINE (ADSORBED)
D.3.9.4	EV Substance Code	SUB11911MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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)	Yes
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: 5
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	diTeBooster, suspension for injection in single-dose vials or pre-filled single-dose syringes
D.2.1.1.2	Name of the Marketing Authorisation holder	AJ Vaccines A/S
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	-
D.3.2	Product code	[-]
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphteria Toxoid (purified), Tetanus Toxoid (purified)
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	DIPHTHERIA AND TETANUS VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
D.3.9.4	EV Substance Code	SUB25254
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphteria Toxoid (purified), Tetanus Toxoid (purified)
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	DIPHTHERIA AND TETANUS VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
D.3.9.4	EV Substance Code	SUB25254
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	20
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)	Yes
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	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderate-to-severe plaque psoriasis in adolescents from 12 to 17 years of age

psoriasi a placche da moderata a grave in soggetti adolescenti (12-17 anni)

E.1.1.1

Medical condition in easily understood language

Moderate-to-severe plaque psoriasis in adolescents from 12 to 17 years of age

psoriasi a placche da moderata a grave in soggetti adolescenti (12-17 anni)

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 determine the efficacy of subcutaneous administration of brodalumab compared with placebo in treating adolescents with moderate-to-severe plaque psoriasis.

Determinare l'efficacia della somministrazione sottocutanea di brodalumab rispetto al placebo nel trattamento di adolescenti con psoriasi a placche da moderata a grave.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of brodalumab compared with ustekinumab in treating adolescents with moderate-to-severe plaque psoriasis.

To evaluate the safety of brodalumab compared with placebo (until Week 12) and ustekinumab (throughout the trial) in adolescents with moderate-to-severe plaque psoriasis.

To evaluate the pharmacokinetics of brodalumab in adolescents with moderate-to-severe plaque psoriasis.

To evaluate the immunogenicity of a tetanus toxoid (TT)-containing vaccine in adolescents with moderateto-severe plaque psoriasis who are treated with brodalumab or placebo.

Valutare l'efficacia di brodalumab rispetto a ustekinumab nel trattamento di adolescenti con psoriasi a placche da moderata a grave.

Valutare la sicurezza di brodalumab rispetto al placebo (fino alla settimana 12) e ustekinumab (per tutto lo studio) negli adolescenti con psoriasi a placche da moderata a grave.

Valutare la farmacocinetica di brodalumab negli adolescenti con psoriasi a placche da moderata a grave.

Valutare l'immunogenicità di un vaccino contenente tossoide del tetamo (TT) negli adolescenti con psoriasi a placche moderata-grave che sono trattati con brodalumab o placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subject was diagnosed with chronic plaque psoriasis at least 6 months before randomisation.
- Subject has a diagnosis of moderate-to-severe plaque psoriasis as defined by PASI =12, sPGA =3, and body surface area =10% at screening and at
baseline.
- Subject, in whom topical therapy is not adequate, and who is a candidate for systemic therapy.
- Subject’s immunisations are up-to-date according to national immunisation programme schedule as specified by country-specific paediatric health authorities. Missing an adolescent dose of combined tetanus, diphtheria, and pertussis (Tdap) or combined tetanus and diphtheria (Td) vaccine is accepted.
- Subject does not have active or history of active tuberculosis, or previously inadequately treated for latent tuberculosis.

- Soggetto a cui è stata diagnosticata una psoriasi a placche cronica almeno6 mesi prima della randomizzazione.
- Il soggetto presenta una diagnosi di psoriasi a placche da moderata a gravecome definita da PASI =12, sPGA =3, e superficie corporea =10%alloscreening e al basale.¿Soggetto per il/la quale la terapia topica non è adeguata, che è candidato/aper la terapia sistemica.
- Le immunizzazioni del soggetto sono aggiornate secondo il programma diimmunizzazione nazionale, come specificato dalle autorità sanitariepediatriche specifiche per paese. Per gli adolescenti, è accettata la mancanza di una dose di vaccino combinato tetano, difterite e pertosse (Tdap) o combinato tetano e difterite (Td).
- Il soggetto non ha una tubercolosi attiva, né una storia di tubercolosi attivae non è stato/a precedentemente trattato/a in modo inadeguato per unatubercolosi latente.

E.4

Principal exclusion criteria

- Subject is diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema).
- Subject has been vaccinated with a TT-containing vaccine =18 months prior to first dose of investigational medicinal product (IMP).
- Subject has developed or experienced either Guillian-Barre syndrome, encephalopathy, Arthus-type hypersensitivity, or severe allergic reactions
in connection with previous Tdap or Td vaccine.
- Subject with chronic or recurrent infections, or active infection, systemically treated within 4 weeks prior to first dose of IMP.
- Subject has a known history of Crohn’s disease.
- Subject has any active malignancy or a history of any malignancy within 5 years.
- Subject has a history of suicidal behaviour and has suicidal ideation with some intent to act or specific plan and intent.
- Subject has a history of depressive disorder with severe episode(s) within the last 2 years.
- Subject has received anti-IL-12/23p40 for less than 12 months prior to the first dose of IMP or has previously no response to anti-IL-12/23p40 therapy.
- Subject has previously received anti-IL-17 therapy.

- Al soggetto viene diagnosticata la psoriasi eritrodermica, la psoriasipustolosa, la psoriasi guttata, la psoriasi indotta da farmaci o altre condizioni della pelle (ad es. Eczema).
- Il soggetto è stato vaccinato/a con un vaccino contenente TT =18 mesiprima della prima dose del medicinale sperimentale (IMP).
-Il soggetto ha sviluppato o ha presentato la sindrome di Guillian-Barre,l'encefalopatia, un'ipersensibilità di tipo Arthus o gravi reazioni allergichein relazione al precedente vaccino Tdap o Td.
-Soggetti con infezioni croniche o ricorrenti, o con infezione attiva, trattatisistematicamente entro 4 settimane prima della prima dose dell'IMP.
- Il soggetto ha una storia nota di malattia di Crohn.
- Il soggetto ha una qualsiasi neoplasia attiva o ha avuto una storia dineoplasia negli ultimi 5 anni.
- Il soggetto ha una storia di comportamento suicida e ha idee suicide conuna certa intenzione di passare all'azione o un progetto specifico conl'intenzione di passare all'azione.
- Il soggetto ha una storia di disturbo depressivo con episodi gravi negliultimi 2 anni.
- Il soggetto ha ricevuto anti-IL-12 / 23p40 per meno di 12 mesi prima dellaprima dose dell'IMP o in precedenza non ha avuto risposta alla terapiaanti-IL-12 / 23p40.
- Il soggetto ha precedentemente ricevuto una terapia anti-IL-17.

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint:
- Having at least 75% improvement in Psoriasis Area and Severity Index
(PASI) score from baseline (PASI 75 response), assessed at Week 12.

Endpoint primario:
Presentare un miglioramento del punteggio Psoriasis Area and SeverityIndex (PASI) di almeno il 75% rispetto al basale (risposta PASI 75)alla Settimana 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

Settimana 12

E.5.2

Secondary end point(s)

Endpoints supporting the primary objective:

Key secondary endpoints:
- Static Physician’s Global Assessment (sPGA) score of 0 or 1, assessed at Week 12.
- sPGA score of 0, assessed at Week 12.
- PASI 90 response, assessed at Week 12.
- PASI 100 response, assessed at Week 12.
- Children’s Dermatology Life Quality Index (CDLQI) total score of 0 or 1, assessed at Week 12.
Secondary endpoint:
- Family Dermatology Life Quality Index (FDLQI) total score of 0 or 1,
assessed at Week 12.

Enpoint che supportano il'obbiettovo primario:
-Presentare un punteggio Physician's Global Assessment (sPGA,valutazione globale del medico) pari a 0 o 1 alla Settimana 12.
-Punteggio sPGA pari a 0, valutato alla Settimana 12.
-Risposta PASI 90, valutata alla Settimana 12.¿Risposta PASI 100, valutata alla Settimana 12.
- Punteggio totale Children's Dermatology Life Quality Index (CDLQI) paria 0 o 1, valutato alla Settimana 12.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 12

Settimana 12

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

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

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

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)

Yes

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

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

Australia

Russian Federation

Belgium

Czechia

France

Germany

Greece

Italy

Netherlands

Spain

United Kingdom

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

The end of the trial is defined as the date of the last visit of the last subject in the trial globally.

La fine dello studio è definito come l'ultima visita dell'ultimo paziente a livello di sperimentazione globale.

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)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

120

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

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

120

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)

In order to ensure appropriate treatment of the subjects after they have completed the trial or if they have been withdrawn from the trial or discontinued IMP treatment prematurely, the subjects will be treated at the investigator’s discretion or referred to other physician(s) according to standard practice.

Al fine di garantire un adeguato trattamento dei soggetti dopo che hanno completato la sperimentazione o se sono stati ritirati dalla sperimentazion o hanno interrotto il trattamento con IMP prematuramente, i soggetti saranno trattati a discrezione dello sperimentatore o indirizzati ad altri medici secondo la pratica standard.

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

2020-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-18

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-05-05

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