Clinical Trials Register

Summary
EudraCT Number:	2022-000491-18
Sponsor's Protocol Code Number:	AT-007-1005
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:	2022-05-18
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

2022-000491-18

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Pharmacodynamic Efficacy and Clinical Benefit of AT 007 in Patients with Sorbitol Dehydrogenase (SORD) Deficiency

Studio in due parti, randomIzzato, in doppio cieco, coNtrollato con placebo per valutare l’efficacia farmacodinamica e il beneficio clinico di AT-007 in (S) Pazienti con defIcit di soRbitolo dEidrogenasi (SORD)

A.3.1

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

A phase 2/3 study to evaluate efficacy and clinical benefit of AT-007 with Sorbitol Dehydrogenase (SORD) Deficiency

Uno studio di fase 2/3 per valutare l'efficacia e il beneficio clinico di AT-007 con deficit di sorbitolo deidrogenasi (SORD)

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

AT-007-1005

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	Applied Therapeutics 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	Applied Therapeutics 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	Applied Therapeutics Inc.
B.5.2	Functional name of contact point	Management
B.5.3	Address:
B.5.3.1	Street Address	545 Fifth Avenue \| Suite 1400
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+12122209226
B.5.6	E-mail	rperfetti@appliedtherapeutics.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	Govorestat
D.3.2	Product code	[AT-007]
D.3.4	Pharmaceutical form	Powder for oral suspension
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	Govorestat
D.3.9.1	CAS number	2170729-29-8
D.3.9.2	Current sponsor code	AT-007
D.3.9.3	Other descriptive name	S292
D.3.9.4	EV Substance Code	SUB213868
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for 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

SoRbitol Dehydrogenase (SORD) DEficiency

Deficit di SoRbitolo Deidrogenasi (SORD)

E.1.1.1

Medical condition in easily understood language

Progressive and debilitating hereditary neuropathy that affects peripheral nerves and motor neurons, resulting in significant disability, loss of sensory function and decreased mobility.

Neuropatia ereditaria progressiva e debilitante che colpisce i nervi periferici e i motoneuroni, con conseguente disabilità significativa, perdita della funz sensoriale e diminuzione della mobilità.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

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	10029328
E.1.2	Term	Neuropathy
E.1.2	System Organ Class	100000004852

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

Clinical Outcome Objectives:
• To evaluate the effect of long-term (24 months) administration of AT-007 on the 10 m walk/run test (10MWRT) in patients with SORD Deficiency 16 to 55 years of age
Pharmacodynamic/Biomarker Objectives:
• To evaluate the effect of long-term (12 months) administration of AT-007 on the levels of blood sorbitol in patients with SORD Deficiency
• To evaluate the effect of long-term (12 months) administration of AT-007 on the levels of blood sorbitol in patients with SORD Deficiency

Obiettivi di risultato clinico:
- Valutare l'effetto della somministrazione a lungo termine (24 mesi) di AT-007 sul test di camminata/corsa di 10 m (10MWRT) in pazienti con deficit di SORD da 16 a 55 anni di età
Obiettivi farmacodinamici/biomarcatori:
- Valutare l'effetto della somministrazione a lungo termine (12 mesi) di AT-007 sui livelli di sorbitolo nel sangue in pazienti con deficit di SORD
- Valutare l'effetto della somministrazione a lungo termine (12 mesi) di AT-007 sui livelli di sorbitolo nel sangue in pazienti con deficit di SORD

E.2.2

Secondary objectives of the trial

Clinical Outcome Objectives:
• To evaluate the effect of long-term (24 months) administration of AT-007 on the Charcot Marie Tooth Health Index (CMTHI) score in patients with SORD Deficiency
• To evaluate the safety of long-term administration and pharmacokinetic (PK) parameters of AT 007 in patients with SORD Deficiency
Pharmacodynamic/Biomarker Objectives:
• To evaluate the effect of long-term (12 months) administration of AT-007 on the percentage of fat in lower extremity muscle as assessed by magnetic resonance imaging (MRI) in patients with SORD Deficiency
• To evaluate the effect of long-term (24 months) administration of AT-007 on the levels of blood sorbitol in patients with SORD Deficiency
• To evaluate the effect of long-term administration (24 months only if Month 12 between-group difference [AT-007 minus placebo] is not statistically significant) of AT-007 on the percentage of fat in lower extremity muscle as assessed by MRI in patients with SORD Deficiency

Obiettivi di risultato clinico:
-Valutare l'effett della somministrazione a lungo ter (24 mesi) di AT-007 sul punteggio del Charcot Marie Tooth Health Index (CMTHI) in pz con deficit di SORD
-Valutare la sicurezza della somministrazione a lungo ter e i parametri farmacocinetici (PK) di AT 007 in pz con deficit di SORD
Obiettivi farmacodinamici/biomarcatori:
-Valutare l'effetto della somministrazione a lungo term (12 mesi) di AT-007 sulla percentuale di grasso nel muscolo dell'arto inferiore come valutato dalla risonanza magn (MRI) in pz con deficit di SORD
-Per valutare l'effetto della somministrazione a lungo term (24 mesi) di AT-007 sui livelli di sorbitolo nel sangue in pz con deficit di SORD
-Valutare l'effetto della somministrazione a lungo term (24 mesi solo se la differenza tra i gruppi al mese 12 [AT-007 meno placebo] non è statisticamente significat) di AT-007 sulla percentuale di grasso nel muscolo dell'arto inf valutata mediante risonanza magnetica in pz con deficit di SORD

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
2. Male and non-pregnant, non-lactating female patients between the ages of 16 and 55 years, inclusive.
3. Females must be of non-childbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy =6 months prior to the first dose of study drug] or postmenopausal for =1 year [confirmatory follicle stimulating hormone or FSH test results required] prior to the first dose of study drug) or agree to use an acceptable form of birth control from Screening until 30 days after the last dose of study drug.
4. Males must be unable to procreate (defined as surgically sterile [i.e.,had a vasectomy =6 months prior to Screening]) or must agree to use an acceptable form of birth control from Screening through 30 days after the last dose of study drug.
5. Clinical diagnosis of CMT2 or dHMN due to SORD Deficiency confirmed by medical record or written communication by health care professional,
elevated sorbitol level (>10,000 ng/mL), and gene analysis report indicating a biallelic mutation in SORD.
6. Patient may be on concomitant medications and dietary supplements; however, they must be on stable doses for at least 1 month prior to Screening and throughout the study. In addition, all over-the-counter (OTC) and/or prescription medications must be reviewed and approved by the Investigator.
7. Willing and able to be confined to the clinical research unit (CRU) as required by the protocol.

1. Disposto e in grado di fornire un consenso informato firmato e datato prima di qualsiasi procedura relativa allo studio e disposto e in grado di rispettare tutte le procedure dello studio.
2. Pazienti maschi e femmine non incinte e non in allattamento di età compresa tra i 16 e i 55 anni, inclusi.
3. Le donne devono essere potenzialmente non fertili (definite come chirurgicamente sterili [cioè, hanno avuto una legatura delle tube bilaterale, isterectomia o ooforectomia bilaterale = 6 mesi prima della prima dose del farmaco in studio] o in postmenopausa da = 1 anno [risultati del test di conferma dell'ormone follicolo-stimolante o FSH richiesti] prima della prima dose del farmaco in studio) o accettare di utilizzare una forma accettabile di controllo delle nascite dallo screening fino a 30 giorni dopo l'ultima dose del farmaco in studio.
4. I maschi devono essere incapaci di procreare (definiti come chirurgicamente sterili [cioè, hanno avuto una vasectomia = 6 mesi prima dello screening]) o devono accettare di utilizzare una forma accettabile di controllo delle nascite dallo screening fino a 30 giorni dopo l'ultima dose del farmaco in studio.
5. Diagnosi clinica di CMT2 o dHMN dovuta al deficit di SORD confermata dalla cartella clinica o dalla comunicazione scritta del medico,
livello elevato di sorbitolo (>10.000 ng/mL), e rapporto di analisi del gene che indica una mutazione biallelica in SORD.
6. Il paziente può assumere farmaci e integratori alimentari concomitanti; tuttavia, essi devono essere a dosi stabili per almeno 1 mese prima dello screening e per tutta la durata dello studio. Inoltre, tutti i farmaci da banco (OTC) e/o da prescrizione devono essere rivisti e approvati dallo sperimentatore.
7. Disposto e capace di essere confinato nell'unità di ricerca clinica (CRU) come richiesto dal protocollo.

E.4

Principal exclusion criteria

1. 10MWRT classified as severe disease, as described in the operating manual.
2. History or presence of clinically significant hematopoietic, renal, hepatic, endocrine (e.g. diabetes), metabolic, pulmonary, neurological (e.g. other neuropathy, myopathy or neuromuscular disorder), psychiatric, cardiovascular, immunological, dermatological, or gastrointestinal diseases that are -at priori- altering the proper
evaluation of the safety and efficacy of AT-007; conditions capable of altering the absorption, metabolism, or elimination of drugs; or conditions that constitute a risk factor when taking the study drug and/or impact the conduct or results of the study.
3. Body Mass Index (BMI) >35 kg/m2.
4. Clinically relevant underweight, weight loss suggestive of a pathology unrelated to SORD deficiency, or BMI < 17.5 kg/m2.
5. Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at Screening or previous treatment for hepatitis B, hepatitis C, or HIV infection.
6. Individuals who smoke or use tobacco or nicotine-containing products.
7. Pregnant, lactating, or not using/not willing to use appropriate means of contraception.
8. Any prior history of substance abuse (including alcohol) or treatment for such.
9. Positive urine drug screen (UDS) for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates) or cotinine.
10. Non-ambulatory disability.
11. Prior bilateral ankle stabilization surgery.
12. Impaired renal function or estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2. Note: The eGFR is an estimation of renal function, and the ultimate decision of whether a patient has normal renal function (and can be included in the study) is at the discretion of the Investigator, assuming there are no safety concerns. Also, because eGFR can vary from day to day based on outside factors, patients can be re screened for eGFR multiple times to understand the
renal function of the patient.
13. Hemoglobin (Hgb) < 10.0 g/dL at Screening.
14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin (except in case of Gilbert's syndrome) > 1.5 x upper limit of normal (ULN) at Screening.
15. Urinary albumin-to-creatinine ratio (UACR) > 30 mg/g at Screening in the presence of elevated creatinine (>2X ULN).
16. History or presence of cardiovascular disorders including myocardial infarction, stroke, uncontrolled hypertension (sitting blood pressure = 140/90 mmHg), left ventricular (LV) hypertrophy, atrial fibrillation, or valvular heart disease considered clinically significant by the Principal Investigator (PI) and/or Sponsor medical representative.
17. Abnormal findings on the Screening 12-lead ECG, such as ST/T wave changes, pathological Q wave changes, or any rhythm other than normal
sinus rhythm considered clinically significant by the PI and/or Sponsor medical representative.
(For the others Exl. criteria please refer to the Protocol)

1. 10MWRT classificato come malattia grave, come descritto nel manuale operativo.
2. Storia o presenza di malattie ematopoietiche, renali, epatiche, endocrine (es. diabete), metaboliche, polmonari, neurologiche (es. altre neuropatie, miopatie o disturbi neuromuscolari), psichiatriche, cardiovascolari, immunologiche, dermatologiche o gastrointestinali clinicamente significative che -a priori- alterano la corretta
valutazione della sicurezza e dell'efficacia di AT-007; condizioni in grado di alterare l'assorbimento, il metabolismo o l'eliminazione dei farmaci; o condizioni che costituiscono un fattore di rischio durante l'assunzione del farmaco in studio e/o hanno un impatto sulla condotta o sui risultati dello studio.
3. Indice di massa corporea (BMI) >35 kg/m2.
4. Sottopeso clinicamente rilevante, perdita di peso suggestiva di una patologia non correlata al deficit di SORD, o BMI < 17,5 kg/m2.
5. Test positivo per l'antigene di superficie dell'epatite B, l'anticorpo dell'epatite C o il virus dell'immunodeficienza umana (HIV) allo screening o precedente trattamento per l'infezione da epatite B, epatite C o HIV.
6. Individui che fumano o usano tabacco o prodotti contenenti nicotina.
7. Gravidanza, allattamento, o non usano/non vogliono usare mezzi contraccettivi appropriati.
8. Qualsiasi storia precedente di abuso di sostanze (incluso l'alcol) o trattamento per questo.
9. 9. Screening delle urine positivo per droghe d'abuso (anfetamine, barbiturici, benzodiazepine, cocaina, oppiacei) o cotinina.
10. Disabilità non deambulante.
11. Precedente intervento chirurgico bilaterale di stabilizzazione della caviglia.
12. Funzione renale compromessa o velocità di filtrazione glomerulare stimata (eGFR) inferiore a 90 mL/min/1,73 m2. Nota: L'eGFR è una stima della funzione renale, e la decisione finale se un paziente ha una funzione renale normale (e può essere incluso nello studio) è a discrezione dello sperimentatore, assumendo che non ci siano problemi di sicurezza. Inoltre, poiché l'eGFR può variare da un giorno all'altro in base a fattori esterni, i pazienti possono essere sottoposti a un nuovo screening dell'eGFR più volte per capire la
funzione renale del paziente.
13. Emoglobina (Hgb) < 10.0 g/dl allo screening.
14. Alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) o bilirubina totale (tranne in caso di sindrome di Gilbert) > 1,5 x limite superiore del normale (ULN) allo screening.
15. Rapporto albumina urinaria/creatinina (UACR) > 30 mg/g allo screening in presenza di creatinina elevata (>2X ULN).
16. Storia o presenza di disturbi cardiovascolari tra cui infarto del miocardio, ictus, ipertensione non controllata (pressione sanguigna seduta = 140/90 mmHg), ipertrofia ventricolare sinistra (LV), fibrillazione atriale o malattia cardiaca valvolare considerata clinicamente significativa dall'investigatore principale (PI) e/o dal rappresentante medico dello sponsor.
17. Risultati anomali sull'ECG di screening a 12 derivazioni, come variazioni dell'onda ST/T, variazioni patologiche dell'onda Q o qualsiasi ritmo diverso dal normale ritmo sinusale considerato clinicamente significativo dal ricercatore principale e/o dal rappresentante medico dello sponsor.
(Per i restanti criteri di escl. si prega di fare riferimento al protocollo)

E.5 End points

E.5.1

Primary end point(s)

Clinical Outcomes Analyses: 10MWRT
Pharmacodynamic and Biomarker Analyses: Blood sorbitol

Analisi dei risultati clinici: 10MWRT
Analisi farmacodinamiche e dei biomarcatori: Sorbitolo nel sangue

E.5.1.1

Timepoint(s) of evaluation of this end point

Clinical Outcomes Analyses: 24 months
Pharmacodynamic and Biomarker Analyses: 12 months

Analisi dei risultati clinici: 24 mesi
Analisi farmacodinamiche e dei biomarcatori: 12 mesi

E.5.2

Secondary end point(s)

Clinical Outcomes Analyses: CMTHI
Pharmacodynamic and Biomarker Analyses:
Percentage of fat in lower extremity muscle as assessed by MRI
Blood sorbitol

Analisi dei risultati clinici: CMTHI
Analisi farmacodinamiche e dei biomarcatori:
Percentuale di grasso nel muscolo dell'arto inferiore come valutato da MRI
Sorbitolo nel sangue

E.5.2.1

Timepoint(s) of evaluation of this end point

Clinical Outcomes Analyses: 24 months
Pharmacodynamic and Biomarker Analyses:
12 months
24 months

Analisi dei risultati clinici: 24 mesi
Analisi farmacodinamiche e dei biomarcatori:
12 mesi
24 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)

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

United States

Czechia

Italy

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

LSLV

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:

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)

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

2022-08-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-01

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

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