Clinical Trials Register

Summary
EudraCT Number:	2021-003192-34
Sponsor's Protocol Code Number:	WN43194
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-11-17
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

2021-003192-34

A.3

Full title of the trial

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)

STUDIO DI FASE III, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO E MULTICENTRICO VOLTO A VALUTARE L’EFFICACIA, LA SICUREZZA, LA FARMACOCINETICA E LA FARMACODINAMICA DI SATRALIZUMAB IN MONOTERAPIA O IN AGGIUNTA ALLA TERAPIA BASALE IN PAZIENTI CON MALATTIA ASSOCIATA AGLI ANTICORPI ANTI-GLICOPROTEINA OLIGODENDROCITARIA MIELINICA (MOGAD)

A.3.1

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

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Lo scopo di questo studio è valutare l’efficacia, la sicurezza, la farmacocinetica e la farmacodinamica di satralizumab in pazienti con malattia associata agli anticorpi anti-glicoproteina oligodendrocitaria mielinica (MOGAD).

A.3.2

Name or abbreviated title of the trial where available

Meteoroid

A.4.1

Sponsor's protocol code number

WN43194

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	F. HOFFMANN - LA ROCHE LTD.
B.1.3.4	Country	Switzerland
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	F. Hoffmann-La Roche Ltd
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Genentech Inc. c/o F. Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0000000
B.5.5	Fax number	0000000
B.5.6	E-mail	global.rochegenentechtrials@roche.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	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	Satralizumab
D.3.2	Product code	[RO5333787]
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	satralizumab
D.3.9.2	Current sponsor code	Ro 533-3787/F01- 06
D.3.9.4	EV Substance Code	SUB195082
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	120
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	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	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	satralizumab
D.3.2	Product code	[RO5333787]
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	Satralizumab
D.3.9.2	Current sponsor code	Ro 533-3787/F01- 04
D.3.9.4	EV Substance Code	SUB195082
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	120
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	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/infusion in pre-filled syringe
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

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Malattia associata agli anticorpi anti-glicoproteina oligodendrocitaria mielinica (MOGAD)

E.1.1.1

Medical condition in easily understood language

MOGAD is a recently coined neuro-inflammatory condition that preferentially causes demyelinating inflammation in the optic nerve but can also cause inflammation in the spinal cord and brain.

MOGAD è una condizione neuro-infiammatoria che causa preferenzialmente infiammazione demielinizzante nel nervo ottico, ma può anche causare infiammazione nel midollo spinale e nel cervello.

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

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	10075688
E.1.2	Term	Autoimmune demyelinating disease
E.1.2	System Organ Class	10029205 - Nervous system 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

To evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period

Valutare l’efficacia di satralizumab rispetto al placebo in base al tempo dalla randomizzazione alla prima comparsa di una recidiva di MOGAD nel periodo di trattamento DB

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of satralizumab compared with placebo based on rate of adjudicated MOGAD relapses, presence of active lesions on magnetic resonance imaging (MRI) of the neuroaxis, rescue therapy use, inpatient hospitalizations, and proportion of relapse-free participants at 6-month intervals
To evaluate the safety of satralizumab compared with placebo

Valutare l’efficacia di satralizumab rispetto al placebo in base al tasso annualizzato di recidive validate di MOGAD, presenza di lesioni attive alla RM del neurasse, terapia di salvataggio, ricoveri in ospedale e percentuale di partecipanti liberi da recidiva a intervalli di 6 mesi.
Valutare la sicurezza di satralizumab rispetto al placebo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Participants who are aged >=12 years at the time of signing Informed Consent Form
- Confimed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening
- Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
- Best corrected visual acuity (BCVA) better than 20/800 in both eyes at screening
- Participants receiving either no ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening or receiving ongoing treatment with azathioprine (AZA), mycophenolate mofetil (MMF), oral
corticosteroids (OCS) prior to and at the time of screening
- No contraindications to rescue treatments
- No contraindications to MRI
- For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab

- Partecipanti di età >=12 anni al momento della firma del Modulo di consenso informato
- Diagnosi confermata di MOGAD con una storia di recidiva di MOGAD>=1 nei 12 mesi precedenti lo screening o >=2 attacchi nei 24 mesi precedenti lo screening
- Punteggio EDSS (Expanded Disability Status Scale) di 0-6,5 allo screening
- Migliore acuità visiva corretta (BCVA) superiore a 20/800 in entrambi gli occhi a selezione
- Partecipanti che non ricevono alcun trattamento immunosoppressore cronico (IST) per MOGAD al momento dello screening o che ricevono un trattamento in corso con azatioprina (AZA), micofenolato mofetile (MMF),
corticosteroidi orali (OCS) prima e al momento dello screening
- Nessuna controindicazione ai trattamenti di salvataggio
- Nessuna controindicazione alla risonanza magnetica
- Per le donne in età fertile: partecipanti che accettano di rimanere in astinenza o di utilizzare un metodo contraccettivo adeguato durante il periodo di trattamento e per almeno 3 mesi dopo la dose finale di satralizumab

E.4

Principal exclusion criteria

- Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
- History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
- Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study
Exclusion Criteria Related to Previous or Concomitant Therapy
- Intravenous immunoglobulins (IVIg) within 4 weeks prior to screening
- Plasma exchange (PLEX) within 4 weeks prior to screening
- OCS, AZA or MMF within 4 weeks prior to screening (if not continued as concomitant IST in the study)
- Tacrolimus or cyclosporine within 6 weeks prior to screening
- B-cell depleting agents, including rituximab (RTX) and ocrelizumab, within 6 months prior to baseline
- Methotrexate within 3 months prior to screening
- Neonatal Fc receptor antagonists within 6 months prior to screening
- IV cyclophosphamide within 6 months prior to screening
- Complement inhibitors within 6 months prior to screening
- Glatiramer acetate and IFN-ß within 1 month prior to screening
- Fumarates within 2 months prior to screening
- Teriflunomide within 2 years prior to screening
- Other MS disease-modifying treatments within 6 months prior to screening
- IL-6 inhibitory therapy at any time
- Total body irradiation, bone marrow transplantation, and autologous hematopoietic stem cell transplantation at any time
- T-cell depleting agents, including but not limited to alemtuzumab, at any time
- Anti-B-lymphocyte stimulator monoclonal antibody at any time
- Cladribine, mitoxantrone, or oral cyclophosphamide at any time
- Treatment with any investigational agent within 24 weeks or 5 drug-elimination half-lives of the investigational drug prior to screening
General Safety Exclusion Criteria
- Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
- Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
- Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
- Participants with positive screening tests for hepatitis B and C
- Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
- History of severe allergic reaction to a biologic agent

- Presenza di anticorpi acquaporina-4 (AQP4-IgG) nel siero
- Storia di encefalite anti-N-metil-d-aspartato recettore (NMDAR)
- Qualsiasi malattia concomitante diversa da MOGAD che può richiedere il trattamento con IST o OCS o corticosteroidi per via endovenosa (IV) a dosi >20 mg di prednisone equivalente al giorno per >21 giorni durante lo studio
Criteri di esclusione relativi a terapie precedenti o concomitanti
- Immunoglobuline endovenose (IVIg) nelle 4 settimane precedenti lo screening
- Scambio di plasma (PLEX) entro 4 settimane prima dello screening
-OCS, AZA o MMF nelle 4 settimane precedenti lo screening (se non continuato come IST concomitante nello studio)
-Tacrolimus o ciclosporina nelle 6 settimane precedenti lo screening
-Agenti che riducono le cellule B, inclusi rituximab (RTX) e ocrelizumab, entro 6 mesi prima del basale
-Metotrexato entro 3 mesi prima dello screening
-Antagonisti del recettore Fc neonatale entro 6 mesi prima dello screening
-Ciclofosfamide IV entro 6 mesi prima dello screening
-Inibitori del complemento entro 6 mesi prima dello screening
-Glatiramer acetato e IFN-ß entro 1 mese prima dello screening
-Fumarati entro 2 mesi prima dello screening
-Teriflunomide entro 2 anni prima dello screening
-Altri trattamenti modificanti la malattia della SM entro 6 mesi prima dello screening
-Terapia inibitoria dell'IL-6 in qualsiasi momento
-Irradiazione corporea totale, trapianto di midollo osseo e trapianto autologo di cellule staminali ematopoietiche in qualsiasi momento
-Agenti che riducono le cellule T, incluso ma non limitato ad alemtuzumab, in qualsiasi momento
-Anticorpo monoclonale stimolatore dei linfociti B in qualsiasi momento
-Cladribina, mitoxantrone o ciclofosfamide orale in qualsiasi momento
-Trattamento con qualsiasi agente sperimentale entro 24 settimane o 5 emivite di eliminazione del farmaco prima dello screening
Criteri generali di esclusione per la sicurezza
-Partecipanti in gravidanza o allattamento o che intendono iniziare una gravidanza durante lo studio o entro 3 mesi dalla dose finale di satralizumab
-Partecipanti con infezione batterica, virale, fungina, micobatterica o altra infezione ricorrente attiva o di altra natura al basale
-Partecipanti con evidenza di tubercolosi latente o attiva (esclusi i pazienti sottoposti a chemioprofilassi per infezione da tubercolosi latente)
-Partecipanti con test di screening positivi per l'epatite B e C
-Ricezione di vaccino vivo o vivo attenuato entro 6 settimane prima del basale
-Storia di grave reazione allergica a un agente biologico

E.5 End points

E.5.1

Primary end point(s)

1. Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC)

1. Tempo dalla randomizzazione alla prima comparsa di una recidiva di MOGAD nel periodo di trattamento DB secondo quanto stabilito da un comitato di validazione (CEC)

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Up to approximately 44 months

1. Fino a circa 44 mesi

E.5.2

Secondary end point(s)

1. Rate of adjudicated MOGAD relapses
2. Active lesions on MRI of the neuroaxis (Gd-enhancing or new/enlarging T2 hyperintense lesions measured across the optic nerve, the spinal cord and the brain, including brainstem and cerebellum)
3. Proportion of participants receiving rescue therapy
4. Rate of inpatient hospitalizations (defined as more than an overnight stay, excluding those for elective procedures)
5. Proportion of relapse-free participants at 6-month intervals
6. Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
7. Change from baseline in targeted vital signs
8. Change from baseline in targeted electrocardiogram (ECG) parameters
9. Change from baseline in targeted clinical laboratory test results
10. Change from baseline in suicidality, as determined by Columbia-Suicide Severity Rating Scale
11. Change from baseline in weight

1. Tasso annullizzato di recidive validate MOGAD
2. Lesioni attive alla RM del neuroasse (lesioni iperintense in T2 nuove/in progressione o captanti Gd a livello di nervo ottico, midollo spinale e cervello, compresi tronco encefalico e cervelletto)
3. Percentuale di partecipanti sottoposti a terapia di salvataggio
4. Tasso annualizzato di ricoveri in ospedale (intesi come ricoveri superiori a una notte, eccetto quelli per procedure elettive)
5. Percentuale di partecipanti liberi da recidiva a intervalli di 6 mesi
6. Incidenza, gravità e severità degli eventi avversi, con severità stabilita in funzione dei criteri NCI CTCAE v5.0
7. Variazione dei segni vitali di interesse rispetto al basale
8. Variazione dei parametri dell’elettrocardiogramma (ECG) di interesse rispetto al basale
9. Variazione dei risultati degli esami clinici di laboratorio di interesse rispetto al basale
10. Variazione della suicidalità rispetto al basale in funzione della Columbia-Suicide Severity Rating Scale
11. Variazione del peso rispetto al basale

E.5.2.1

Timepoint(s) of evaluation of this end point

1-5. Up to approximately 44 months
6-11. Baseline to up to approximately 44 months

1-5. Fino a circa 44 mesi
6-11. Dal basale fino a circa 44 mesi

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

Yes

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)

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

Brazil

Canada

China

Japan

Korea, Republic of

United States

France

Germany

Italy

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 DB treatment period of the study will end when the total number of participants with adjudicated relapses reaches 28, with the CCOD defined as the date 12 weeks after the RA visit for the 28th adjudicated relapse or the RFA visit of the participant with the 28th adjudicated relapse, whichever occurs later. The end of the OLE treatment period is expected to be approximately 2 years after the end of the DB treatment period.

Il periodo di trattamento DB dello studio terminerà dopo 28 recidive validate (data del cut-off clinico [CCOD] dopo che il 28° partecipante con recidiva validata sarà stato sottoposto a RFA o 12 settimane dopo la visita RA per la 28° recidiva validata, a seconda della circostanza che si verifichi per ultima).

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:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

124

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

152

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)

After Week 24 in the DB treatment and/or OLE period and in accordance with local regulations, administration of study drug at or outside of the study site (e.g. home treatment [self-administration, or administration by a trained caregiver or mobile nurse]) may be allowed on scheduled study drug administration days that do not require additional assessments that must be performed at the site.

Dopo la settimana 24 nel trattamento DB e/o periodo OLE e in conformità con le normative locali, la somministrazione del farmaco in studio presso o al di fuori del centro clinico (ad es. trattamento domiciliare [autosomministrazione o somministrazione da parte di un assistente qualificato o infermiere mobile]) può essere consentito nei giorni programmati di somministrazione del farmaco in studio che non richiedono ulteriori valutazioni che devono essere eseguite presso il centro.

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

2022-01-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-15

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

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