Clinical Trials Register

Summary
EudraCT Number:	2018-002790-22
Sponsor's Protocol Code Number:	ML39921
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-03-18
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

2018-002790-22

A.3

Full title of the trial

Tocilizumab in Graves’ Orbitopathy (TOGO). Multicenter, randomized, observer-blind, controlled study of the anti-IL-6 receptor antibody tocilizumab (TCZ) or methylprednisolone (MP) treatment in patients with active moderate-severe Graves' orbitopathy

Studio multicentrico, randomizzato, controllato in singolo cieco del trattamento con anticorpo monoclonale anti-IL6 (tocilizumab) o metilprednisolone nell’orbitopatia di Graves (GO) attiva di grado moderato-severo

A.3.1

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

Efficacy evaluation of tocilizumab in the treatment Graves' Orbitopathy

Valutazione dell’efficacia di tocilizumab nel trattamento dell’orbitopatia basedowiana

A.3.2

Name or abbreviated title of the trial where available

TOGO - Tocilizumab in Graves' Orbitopathy

TOGO - Tocilizumab nell'orbitopatia basedowiana

A.4.1

Sponsor's protocol code number

ML39921

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	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Roche S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Ca' Granda Ospedale Maggiore Polcilinico
B.5.2	Functional name of contact point	UOC Endocrinologia
B.5.3	Address:
B.5.3.1	Street Address	Via Francesco Sforza, 35
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	0255033332
B.5.5	Fax number	0250320605
B.5.6	E-mail	mario.salvi@policlinico.mi.it

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	ROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION LIMITED
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	Roactemra
D.3.2	Product code	Tocilizumab
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TOCILIZUMAB
D.3.9.1	CAS number	0375823-41-9
D.3.9.2	Current sponsor code	TOCILIZUMAB
D.3.9.3	Other descriptive name	TOCILIZUMAB
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	8
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	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	SOLU MEDROL - 500 MG/8 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE DI POLVERE DA 500 MG+ FIALA SOLVENTE DA 8 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA S.R.L.
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	SOLU MEDROL
D.3.2	Product code	SOLU MEDROL
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METILPREDNISOLONE
D.3.9.1	CAS number	83-43-2
D.3.9.2	Current sponsor code	METILPREDNISOLONE
D.3.9.3	Other descriptive name	METILPREDNISOLONE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
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.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

Active moderate-severe Graves' Orbitopathy

Orbitopatia basedowiana di grado moderato-severo in fase attiva

E.1.1.1

Medical condition in easily understood language

Garcves' Orbitopathy in the zacute inflammatory phase

Oftalmopatia di Basedow in fase infiiammatoria acuta

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

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	10015684
E.1.2	Term	Exophthalmos endocrine
E.1.2	System Organ Class	100000004853

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10014702
E.1.2	Term	Endocrine exophthalmos
E.1.2	System Organ Class	100000004853

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Efficacy of therapy on active GO and on disease progression

Efficacia della terapia nel trattamento dell’orbitopatia basedowiana attiva moderata severa e sulla progressione di malattia

E.2.2

Secondary objectives of the trial

Effect of therapy on the proportion of patients with inactivation and reactivation of disease, improvement of QoL, the degree of residual disease after the inflammatory phase and safety of treatment.

Efficacia della terapia misurata come percentuale di pazienti che presentano inattivazione o riattivazione della malattia, miglioramento della qualità di vita, grado di malattia residua dopo l’inattivazione e sicurezza del trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent
2. Male or female, 18-75 years old
3. Women of childbearing potential should use effective contraception (abstinence or use contraceptive methods with a failure rate of <1%) throughout study and for a minimum of 6 months after study drug therapy and must have a negative serum pregnancy test at screening
4. GO at first diagnosis or at the time of relapse of no more than 9 months' duration.
5. Patients with moderate-severe active GO (clinical activity score 4/10 assessed at the end of the screening period) untreated or previously treated with i.v. steroids withdrawn for at least 3 months.
6. Euthyroid for at least 6-8 weeks (serum free hormone concentrations within 20% of normal range), on either anti-thyroid medications (tyonamides) to control hyperthyroidism or L-thyroxine for replacement therapy for hypothyroidism.
7. Patients will also be allowed to stay on propranolol treatment for the control of tachycardia.

1. Firma del consenso informato
2. Maschi o femmine di età 18-75 anni
3. DLe donne in età fertile devono usare una contraccezione efficace (astinenza o uso di metodi contracettivi con tasso di fasllimento <1%) per tutta la durata dello studio e per un minimo di 6 mesi dopo la fine del trattamento e devono avere un test di gravidanza negativo allo screening.
4. Oftalmopatia di Graves di prima diagnosi o recidivante, di non più di 9 mesi di durata.
5. Pazienti con oftalmopatia attiva di grado moderato-severo (clinical activity score 4/10 assegnato alla fine del periodo di screening) non trattati o trattati precedentemente con steroidi ev, sospesi da almeno 3 mesi.
6. Pazienti eutiroidei da almeno 6-8 settimane (concentrazioni sieriche di ormoni tiroidei liberi entro 20% del normal range), trattati sia con farmaci antitiroidei (tionamidi)se ipertiroidei o con L-Tiroxina, se ipotiroidei.
7. I pazienti potranno mantenere la terapia con propanololo per la tachicardia.

E.4

Principal exclusion criteria

Patients with severe Graves’ orbitopathy (severe keratopathy, compression optic neuropathy and inflammatory optic neuropathy);Treatment with any biological therapy at any time; Previous oral or intravenous corticosteroid treatment in the last three months except for oral steroid not exceeding a cumulative dose of 1 gr. ; Plasmapheresis within 90 days prior to Day 0.; Treatment with intravenous immunoglobulin; Azathioprine more than 100 mg/day within 30 days before screening; Administration of live vaccines given within 30 days prior to administration of (Day 0) or concurrently with tocilizumab (during study); Splenectomy; Subjects at risk of haemorrhage that threatens a vital organ; History of a major organ transplant or hematopoietic stem cell/marrow transplant; History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix; Required management of infections, as follows: currently on any suppressive therapy for a chronic infection, hospitalization for treatment of infection within 60 days before Day 0, use of parenteral antibiotics within 60 days before Day 0, use of oral antibiotics within 30 days before Day 0; Pregnancy; Patients with reproductive potential not willing to use an effective method of contraception; Breast feeding; Previous history of intestinal ulceration or diverticulitis; Known unstable coronary artery disease; Significant cardiac arrhythmias; Severe congestive heart failure; Other serious chronic illness (including nervous system disease, pulmonary disease including obstructive pulmonary disease, renal disease);Active infection; History of recurrent clinically significant infection or recurrent bacterial infections; History of sarcoidosis; Primary or secondary immunodeficiency; History of IgE-mediated or non-IgE-mediated hypersensitivity; Positive PPD or quantiferon without documentation of treatment for TB infection; Denied consent to HIV testing; Previous orbital radiotherapy; Patients positive for HBsAg; Patients positive for HBcAb regardless of HBsAb status will undergo HBV DNA which, if positive, will be excluded; Patients positive at screening Hepatitis C antibody; Positive test for Human Immunodeficiency Virus (HIV) antibody at screening or historically; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater or equal to 1.5x upper limit of normal (ULN); Alkaline phosphatase and bilirubin>1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is<35%); Grade 3 / 4 IgG deficiency and IgA deficiency (IgA < 10mg/dL); History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy including a previous anaphylactic reaction to parenteral administration contrast agents, human or murine proteins or monoclonal antibodies; Major depression; Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk; Current drug or alcohol abuse or dependence; White blood cells < 3.0 x 109/L (3000/mm3); Absolute neutrophil count (ANC) < 2.0 x 109/L (2000/ mm3); Absolute lymphocyte count < 0.5 x 109/L (500/ mm3); Platelet count <100 x 109/L; Serum creatinine > 1.4 mg/dl (124 µmol/L) in female patients and > 1.6 mg/dl (141 µmol/L) in male patients; Hemoglobin <85 g/L (8.5 g/dL; 5.3 mmol/L); Demyelinating disordes.

Pazienti affetti da orbitopatia di grado severo (cheratopatia, neuropatia ottica compressiva e neurite ottica); Pregresso trattamento con farmaci biologici; Trattamento con corticosteroidi per via orale o endovenosa nei 3 mesi antecedenti alla fase di screening, ad eccezione di una dose cumulativa di 1 g di steroidi per via orale; plasmaferesi nei 90 giorni antecedenti al giorno 0; Somministrazione di immunoglobuline per via endovenosa; Assunzione di più di 100 mg/die di azatioprina nei 30 giorni antecedenti lo screening; Somministrazione di vaccini vivi nei 30 giorni antecedenti la prima somministrazione di tocilizumab (giorno 0) o durante il perodo di trattamento; splenectomia; Soggetti a rischio di emorragia che mette a rischio organi vitali; Pregresso trapianto d’organo o di midollo osseo; Neoplasia nei 5 anni antecedenti lo screening, ad eccezione di carcinoma cutaneo adeguatamente trattato (carcinoma baso-cellulare o squamo-cellulare) o carcinoma in situ della cervice uterina; Assunzione di trattamento per infezioni croniche tra cui: terapia immunosoppressiva per infezioni croniche, ricovero per il trattamento di una patologia infettiva nei 60 giorni antecedenti il giorno 0; assunzione di antibiotici per via endovenosa nei 60 giorni antecedenti il giorno 0; utilizzo di antibiotici per via orale nei 30 giorni antecedenti il giorno 0; gravidanza in corso; pazienti in età fertile che rifiutano l’utilizzo di metodi contraccettivi sicuri; allattamento in corso; pregressa ulcera gastrointestinale o diverticolite; nota malattia coronarica non controllata; significativa aritmia cardiaca; severa cardiopatia congestizia; presenza di altra patologia cronica severa (incluse le malattie del sistema nervoso, le patologie polmonari tra cui la broncopatia cronica ostruttiva e le malattie renali); infezione attiva; pregresse infezioni ricorrenti clinicamente rilevanti o infezioni batteriche ricorrenti; sarcoidosi; Immunodeficienza primaria o secondaria; storia di ipersensitività IgE o non-IgE mediata; Test di Mantoux o Quantiferon test positivi in mancanza di documentazione che attesti un pregresso trattamento della TBC; mancato consenso al test HIV; Pregressa radioterapia orbitaria; pazienti positivi per HBsAg; i pazienti con HBcAb positivi, ad eccezione dei pazienti con concomitanti HBsAb positivi, verranno sottoposti a quantificazione dell’HBV-DNA e, se positivo, verranno esclusi dallo studio; pazienti con anticorpi anti- HCV positivi;test HIV positivo allo screening o in passato; aspartato amino transferasi (AST) o alanina amino transferasi (ALT) superiori o uguali a 1.5 volte il limite superiore di norma (ULN); fosfatasi alcalina e bilirubina superiori a 1.5 volte ULN (valori di bilirubina isolati superiori a 1.5 volte ULN sono accettabili se si tratta di bilirubina frazionata e la bilirubina diretta è inferiore al 35%); Deficit di IgG di grado 3 o 4 e deficit di IgA con IgA<10mg/dl); ipersensibilità nota ai farmaci in studio o a loro eccipienti o storia di allergie a farmaci o altre allergie tra cui reazioni anafilattiche a mezzi di contrasto, ad anticorpi umani o murini o monoclonali somministrati per via endovenosa; depressione maggiore; evidenza di rischio di suicidio compresi comportamenti suicidi o tentato suicidio nei 2 mesi antecedenti lo screening o presenza di rischio di suicidio a giudizio del clinico; corrente abuso di alcol o sostanze stupefacenti; Globuli bianchi totali < 3.0 x 109/L (3000/mm3); Numero assoluti dei neutrofili < 2.0 x 109/L (2000/ mm3); Numero assoluto dei linfociti < 0.5 x 109/L (500/ mm3); Conta piastrinica <100 x 109/L; Creatinina serica > 1.4 mg/dl (124 µmol/L) nelle femmine e > 1.6 mg/dl (141 µmol/L) nei maschi;
Emoglobina serica <85 g/L (8.5 g/dL; 5.3 mmol/L); Presenza di malattia demielinizzante

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients improved at 24 weeks as assessed by the EUGOGO composite ophthalmic score

Percentuale di pazienti migliorati a 24 settimane dal trattamento, definito attraverso lo score oftalmologico composito definito dal gruppo EUGOGO

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks

24 settimane

E.5.2

Secondary end point(s)

Number of rehabilitative surgical interventions at the end of follow-up

Numero di interventi chirurgici riabilitativi alla fine del periodo di follow-up

E.5.2.1

Timepoint(s) of evaluation of this end point

at week 48

48ma settimana

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

E.8.1.4

Double blind

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)

Yes

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

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

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

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

Yes

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

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)

None

Nessuno

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

2019-04-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-02-19

P. End of Trial
P.	End of Trial Status	Completed

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