Clinical Trials Register

Summary
EudraCT Number:	2019-002788-88
Sponsor's Protocol Code Number:	20190529
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:	2021-05-20
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

2019-002788-88

A.3

Full title of the trial

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)

Studio di fase III, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli, atto a valutare l’efficacia, la sicurezza e la farmacocinetica di apremilast nei bambini di età compresa tra i 5 e i 18 anni con artrite psoriasica giovanile attiva (PEAPOD)

A.3.1

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

Apremilast Study in Children with Active Juvenile Psoriatic Arthritis

Studio con apremilast nei bambini affetti da artrite psoriasica giovanile attiva

A.3.2

Name or abbreviated title of the trial where available

PEAPOD

A.4.1

Sponsor's protocol code number

20190529

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/388/2019

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AMGEN INC.
B.1.3.4	Country	United States
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	Amgen Inc.
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	Amgen S.r.l.
B.5.2	Functional name of contact point	Medical Information
B.5.3	Address:
B.5.3.1	Street Address	Via Tazzoli 6
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20154
B.5.3.4	Country	Italy
B.5.4	Telephone number	0039026241121
B.5.5	Fax number	0039026241121
B.5.6	E-mail	medicalinformationitaly@amgen.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	OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN EUROPE B.V
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	Apremilast 20 mg
D.3.2	Product code	[AMG407]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Apremilast
D.3.9.1	CAS number	608141-41-9
D.3.9.2	Current sponsor code	AMG407
D.3.9.4	EV Substance Code	SUB130837
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	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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: 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	OTEZLA - 30 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 56 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN EUROPE B.V
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	Apremilast 30 mg
D.3.2	Product code	[AMG407]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Apremilast
D.3.9.1	CAS number	608141-41-9
D.3.9.2	Current sponsor code	AMG407
D.3.9.4	EV Substance Code	SUB130837
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	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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: 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	Yes
D.2.1.1.1	Trade name	OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN EUROPE B.V
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	Apremilast 10 mg
D.3.2	Product code	[AMG407]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Apremilast
D.3.9.1	CAS number	608141-41-9
D.3.9.2	Current sponsor code	AMG407
D.3.9.4	EV Substance Code	SUB130837
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	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	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	Apremilast
D.3.2	Product code	[AMG407]
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Apremilast
D.3.9.2	Current sponsor code	AMG407
D.3.9.4	EV Substance Code	SUB130837
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	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral suspension
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Juvenile psoriatic arthritis

Artrite psoriasica giovanile

E.1.1.1

Medical condition in easily understood language

Joint inflammation with Skin disorder (Psoriasis) affecting pediatric individuals.

Infiammazione delle articolazioni con disturbo della pelle (psoriasi) che colpisce i soggetti pediatrici.

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10079454
E.1.2	Term	Systemic juvenile idiopathic arthritis
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis in pediatric subjects 5 to less
than 18 years of age;

Stimare l’efficacia di apremilast rispetto al placebo nel trattamento della JPsA nei soggetti pediatrici di età compresa tra 5 e < 18 anni

E.2.2

Secondary objectives of the trial

- Estimate effect of apremilast compared to placebo on pain in pediatric subjects (5 to less than 18 years) with JPsA;
- Estimate effect of apremilast compared to placebo on ACR Pedi 20/50/70/90 response, respective core components, and on juvenile
arthritis disease activity in pediatric subjects with JPsA;
- Estimate impact on HRQoL in pediatric subjects with JPsA;
- Estimate efficacy of apremilast compared to placebo for overall JPsA related disease activity in pediatric subjects with JPsA;
- Estimate effect of apremilast compared to placebo on psoriatic arthritis flares in pediatric subjects with JPsA;

Please, refer to protocol for the full list

- Stimare l’effetto analgesico di apremilast rispetto al placebo nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;
- Stimare l’effetto di apremilast rispetto al placebo sulle risposte ACR Pedi 20/50/70/90, sui rispettivi componenti centrali e sull’attività dell’artrite giovanile nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;
- Stimare l’impatto sull’HRQoL di apremilast rispetto al placebo nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;
- Stimare l’efficacia di apremilast rispetto al placebo per l’attività di malattia globale della JPsA nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;
- Stimare l’effetto di apremilast rispetto al placebo sui flare di artrite psoriasica nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;

* Fare riferimento al protocollo per la lista completa

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or Female subjects 5 to less than 18 years of age at the time of randomization.
2. Confirmed diagnosis of JPsA according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:
-Arthritis and psoriasis, OR
-Arthritis with at least 2 of the following:
-Dactylitis
-Nail pitting or onycholysis
- Psoriasis in a first-degree relative
3. Active disease: at least 3 active joints (including distal interphalangeal joints).
4. Inadequate response (at least 2 months) or intolerance to = 1 DMARD, (which may include MTX or biologic agents).

Other protocol-defined inclusion criteria apply

1. Soggetti di sesso maschile o femminile di età compresa tra 5 e < 18 anni al momento della randomizzazione;
2. Diagnosi confermata di JPsA secondo i criteri di classificazione ILAR, revisione Edmonton (Petty, 2001), della durata di almeno 6 mesi:
- Artrite o psoriasi, OPPURE
- Artrite con almeno 2 dei seguenti:
o Dattilite
o Pitting ungueale od onicolisi
o Psoriasi in un parente di primo grado
3. Malattia attiva: almeno 3 articolazioni attive (incluse le articolazioni interfalangee distali)
4. Risposta inadeguata (per >= 2 mesi) o intolleranza a >= 1 DMARD, che può includere MTX o agenti biologici.

Per un elenco completo dei criteri di eleggibilità, consultare il protocollo

E.4

Principal exclusion criteria

1.Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:
- Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
- Ankylosing spondylitis, enthesitis-related arthritis, sacroiliitis with inflammatory bowel disease,
- Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
- History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
- Presence of systemic JIA.
2. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
3. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
4. History or evidence of any other clinically significant disorder, condition or disease that could pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
5. Female subject who is (or plans to become) pregnant or breastfeeding.
6. Female subject of childbearing potential unwilling to use 1 highly effective method of contraception.

Other protocol-defined exclusion criteria apply.

1. I criteri di esclusione secondo la classificazione ILAR revisione Edmonton (Petty, 2001), includono:
- Artrite in un soggetto maschile positivo per HLA-B27 con insorgenza di artrite dopo i 6 anni di età
- Spondilite anchilosante, artrite correlata ad entesite, sacroileite con malattia infiammatoria intestinale,
- Sindrome di Reiter, uveite anteriore acuta o anamnesi di uno di questi disturbi in un parente di primo grado
- Storia del fattore reumatoide IgM in almeno 2 occasioni ad almeno 3 mesi di distanza
- Presenza di AIG sistemica.
2. Malattia autoimmune reumatica diversa da PsA, inclusi, ma non limitati a: lupus eritematoso sistemico, malattia mista del tessuto connettivo, sclerodermia, polimiosite o fibromialgia.
3. Anamnesi pregressa o attuale malattia infiammatoria articolare diversa da AP (ad es. Gotta, artrite reattiva, artrite reumatoide, spondilite anchilosante, malattia di Lyme).
4. Anamnesi o evidenza di qualsiasi altro disturbo, condizione o malattia clinicamente significativa che potrebbe rappresentare un rischio per la sicurezza dei soggetti o interferire con la valutazione, le procedure o il completamento dello studio.
5. Soggetto di sesso femminile che è (o intende rimanere) incinta o che allatta.
6. Soggetto di sesso femminile in età fertile che non desidera utilizzare 1 metodo contraccettivo altamente efficace.

Per un elenco completo dei criteri di esclusione, consultare il protocollo

E.5 End points

E.5.1

Primary end point(s)

Number of participants achieving ACR Pedi 30

Numero di partecipanti che raggiungono una risposta ACR Pedi 30

E.5.1.1

Timepoint(s) of evaluation of this end point

from baseline (week 0) to week 16

dal basale (settimana 0) alla settimana 16

E.5.2

Secondary end point(s)

- Change in subject's assessment of pain (a);
- Number of participants achieving ACR Pedi 20/50/70/90 (a);
- Change in Childhood Heath Assessment Questionnaire (CHAQ) (a);
- Change in Juvenile Arthritis Disease Activity Score (JADAS) (a);
- Number of participants who experience PsA flares (a);
- PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a);
- Number of participants who experience treatment-emergent adverse events (type, frequency, severity and relationship to apremilast) (b);

*Please, refer to protocol for the full list

- Cambiamento nella valutazione del dolore da parte del soggetto (a);
- Numero di partecipanti che hanno raggiunto ACR Pedi 20/50/70/90 (a);
- Cambiamento nel Childhood Health Assessment Questionnaire (CHAQ) (a);
- Variazione del punteggio di Juvenile Arthritis Disease Activity (JADAS) (a);
- Numero di partecipanti che sperimentano flare di PsA (a);
- Risposta PASI-75 alla settimana 16 per soggetti con psoriasi al basale che presentano BSA uguale o superiore al 3% (a);
- Numero di partecipanti che hanno manifestato eventi avversi trattamento correlati (tipo, frequenza, gravità in relazione ad apremilast) (b)

* Fare riferimento al protocollo per la lista completa

E.5.2.1

Timepoint(s) of evaluation of this end point

(a) from baseline (week 0) to week 16
(b) from baseline (week 0) to week 56

(a) dal basale (settimana 0) alla settimana 16
(b) dal basale (settimana 0) alla settimana 56

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

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

dal basale (settimana 0) alla settimana 16

Gusto e Accettabilità

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

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

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 subjects who complete the week 52 visit and all assessments at this visit will have the opportunity to enroll in a separate optional openlabel, long-term study for 4 years or until apremilast is commercially available for JPsA (whichever comes earlier) or until the benefit/risk of apremilast is found not to be acceptable for JPsA, according to either the Sponsor or health authority.

Tutti i soggetti che completano la visita alla settimana 52 e tutte le valutazioni durante la visita avranno l'opportunità di essere arruolati in uno studio opzionale in aperto, a lungo termine di 4 anni o fino a quando apremilast non sarà disponibile sul mercato per il trattamento della JPsA o fino a quando il profilo beneficio/rischio di apremilast non sarà considerato accettabile per JPsA, secondo lo Sponsor o l'Autorità Competente.

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

2021-03-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-12-07

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

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