Clinical Trials Register

Summary
EudraCT Number:	2019-004764-22
Sponsor's Protocol Code Number:	SPR001-203
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:	2021-10-07
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

2019-004764-22

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia

Studio randomizzato, in doppio cieco, controllato con placebo, con dosi variabili, volto a valutare l’efficacia e la sicurezza di SPR001 (Tildacerfont) in soggetti adulti affetti da iperplasia surrenale congenita classica

A.3.1

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

This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that will evaluate the efficacy and safety of up to 52 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baseline.

Questo è uno studio randomizzato, in doppio cieco, controllato con placebo, con un periodo di trattamento in 3 parti che valuterà l’efficacia e la sicurezza del trattamento fino a 52 settimane con Tildacerfont in soggetti con iperplasia surrenale congenita classica (CAH) che hanno elevati livelli ematici al basale.

A.3.2

Name or abbreviated title of the trial where available

Study to Evaluate Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adre

Studio volto a valutare l’efficacia e la sicurezza di Tildacerfont in soggetti adulti affetti da ipe

A.4.1

Sponsor's protocol code number

SPR001-203

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	Spruce Biosciences 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	Spruce Biosciences, 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	Spruce Biosciences, Inc.
B.5.2	Functional name of contact point	Rosh Dias
B.5.3	Address:
B.5.3.1	Street Address	2001 Junipero Serra Blvd, Suite 640
B.5.3.2	Town/ city	Daly City
B.5.3.3	Post code	CA 94014
B.5.3.4	Country	United States
B.5.4	Telephone number	0016508629761
B.5.6	E-mail	rdias@sprucebiosciences.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	Yes
D.2.5.1	Orphan drug designation number	EMA/OD/164/17
D.3 Description of the IMP
D.3.1	Product name	Tildacerfont
D.3.2	Product code	[SPR001]
D.3.4	Pharmaceutical form	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	TILDACERFONT
D.3.9.1	CAS number	1014983-00-6
D.3.9.2	Current sponsor code	SPN001
D.3.9.4	EV Substance Code	SUB192788
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	50
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	HYDROCORTISONE- hydrocortisone tablet
D.2.1.1.2	Name of the Marketing Authorisation holder	Greenstone LLC
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	HYDROCORTISONE- hydrocortisone tablet
D.3.2	Product code	[National Drug Code: 59762-0074]
D.3.4	Pharmaceutical form	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	IDROCORTISONE
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	HYDROCORTISONE
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.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	Tablet
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

Classic Congenital Adrenal Hyperplasia

Iperplasia Surrenalica Congenita Classica

E.1.1.1

Medical condition in easily understood language

CAH is a serious, chronically debilitating, and life-threatening genetic disorder characterized by impaired adrenal synthesis of cortisol and overproduction of adrenal androgens

ISC è una grave malattia genetica cronica invalidante e potenzialmente letale, con compromissione della sintesi surrenale del cortisolo con conseguente iperproduzione di androgeni surrenalici.

E.1.1.2

Therapeutic area

Body processes [G] - Genetic Phenomena [G05]

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	10010323
E.1.2	Term	Congenital adrenal hyperplasia
E.1.2	System Organ Class	100000004850

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	10010323
E.1.2	Term	Congenital adrenal hyperplasia
E.1.2	System Organ Class	100000004850

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 effect of tildacerfont in reducing A4 in subjects with CAH over 12 weeks

Valutare l’effetto di Tildacerfont nella riduzione dei livelli di A4 in soggetti con ISC nell’arco di 12 settimane

E.2.2

Secondary objectives of the trial

To evaluate the effect of tildacerfont in reducing key hormones in subjects with CAH over 12 weeks

Valutare l’effetto di Tildacerfont nella riduzione dei livelli degli ormoni principali in soggetti con ISC nell’arco di 12 settimane

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female subjects =18 years old at screening
2. Has a documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based on genetic mutation in CYP21A2 and/or elevated 17-OHP
3. Has A4 >1.5x ULN and ACTH >2x ULN at both screening and Week 4 (measured before any AM GC dose)
4. Has been on a stable dose of GC replacement =15 mg/day and =50 mg/day in HCe that does not vary in total daily dose from day to day for =1 month before screening without any evidence of non-adherence to the GC regimen during this period (stress dosing is allowed)
5. For subjects with the salt-wasting form of CAH, subject has been on a stable dose of mineralocorticoid replacement for =1 month before screening
6. Agrees to follow contraception guidelines. Male subjects must also agree to refrain from donating sperm throughout the treatment period and for 90 days after the last dose of study drug.
7. Is able to understand all study procedures and risks involved and provides written informed consent indicating willingness to comply with all aspects of the protocol.

1. Soggetti di ambo i sessi di età =18 anni allo screening
2. Presenza di una diagnosi anamnestica documentata di ISC classica dovuta a deficit di 21-idrossilasi in base alla mutazione genetica in CYP21A2 e/o elevati livelli di 17-OHP
3. Livelli di A4 >1,5 x ULN e ACTH >2 x ULN sia allo screening che alla Settimana 4 (misurati prima di qualsiasi dose mattutina di GC)
4. Il soggetto ha assunto una dose stabile di GC sostitutivi =15 mg/giorno e =50 mg/giorno in HCe che non varia nel dosaggio giornaliero totale di giorno in giorno per =1 mese prima dello screening senza alcuna evidenza di mancata aderenza al regime di GC durante questo periodo (è consentita la somministrazione da stress)
5. Per i soggetti che presentano la forma di ISC con perdita di sali, il soggetto deve aver assunto una dose stabile di mineralcorticoidi sostitutivi per =1 mese prima dello screening
6. Il soggetto acconsente a seguire le linee guida sulla contraccezione. I soggetti di sesso maschile devono inoltre accettare di astenersi dal donare sperma per tutto il periodo di trattamento e per 90 giorni dopo l’ultima dose del farmaco in studio
7. Il soggetto è in grado di comprendere tutte le procedure e i rischi dello studio coinvolti e fornisce il consenso informato scritto specificando la propria volontà di attenersi a tutti gli aspetti del protocollo

E.4

Principal exclusion criteria

1. Has a known or suspected diagnosis of any other known form of classic CAH (not due to 21-hydroxylase deficiency)
2. Has a history that includes bilateral adrenalectomy or hypopituitarism
3. Has a history of allergy or hypersensitivity to tildacerfont, any of its excipients, or any other CRF1 receptor antagonist
4. Current treatment with dexamethasone as GC therapy for CAH
5. Is not adherent to GC or study drug dosing regimen during the Run-in Period (defined as taking <80% of expected doses as directed; stress dosing of GCs is allowed)
6. Shows clinical signs or symptoms of adrenal insufficiency
7. Has had a clinically significant unstable medical condition, medically significant illness, or chronic disease occurring within 30 days of screening
8. Uncontrolled psychiatric conditions, including but not limited to major depression, bipolar disorder, schizophrenia, or schizoaffective disorders. Symptoms including hallucinations, delusions, and psychosis are exclusionary.
9. Has clinically significant abnormal ECG or clinical laboratory results.
10. Routinely works overnight shifts
11. Subjects with travel plans/work schedules that result in significant and frequent changes in time zones (>2 hours) will require Medical Monitor approval for enrollment.
12. Females who are pregnant or nursing
13. Use of any other investigational drug from 30 days or 5 half-lives (whichever is longer) before screening to the end of the study
14. Use of the following drugs from 30 days or 5 half-lives (whichever is longer) before Day 1 to the end of the study:
a. Rosiglitazone, aromatase inhibitors, testosterone, growth hormones, or any other medication or supplement that could impact subject safety or confound interpretation of study results
b. The drugs:
i. Moderate to strong inhibitors and/or inducers of CYP3A4
ii. Sensitive substrates or narrow-therapeutic-range substrates of CYP3A4 (except hormonal contraception containing ¿20 ¿g ethinyl estradiol)
iii. Sensitive substrates or narrow-therapeutic-range substrates of BCRP (except those that can be administered QD in the morning, separated by approximately 10 hours from evening administration of study drug)
15. Use of any anticoagulants or antiplatelet therapies other than aspirin within 30 days before screening
16. Has a history of an active bleeding disorder
17. Donation or receipt of blood from 90 days before Screening to the end of the study; donation or receipt of platelets, white blood cells, or plasma from 30 days before Screening to the end of the study

1. Il soggetto presenta una diagnosi nota o sospetta di qualsiasi altra forma nota di ISC classica (non dovuta a deficit di 21-idrossilasi)
2. Il soggetto presenta un’anamnesi che include surrenectomia bilaterale o ipopituitarismo
3. Anamnesi di allergia o ipersensibilità a tildacerfont, a qualsiasi dei suoi eccipienti o qualsiasi altro antagonista del recettore di CRF1
4. Trattamento in corso con desametasone come terapia con GC per l’ISC
5. Mancata aderenza allo schema posologico di GC o del farmaco in studio durante il periodo di run-in (definita come l’assunzione di <80% delle dosi previste secondo le indicazioni; è consentita la somministrazione da stress di GC)
6. Il soggetto mostra segni o sintomi clinici di insufficienza surrenalica
7. Il soggetto ha manifestato una condizione medica instabile clinicamente significativa, malattia clinicamente significativa o malattia cronica che si è verificata entro 30 giorni dallo screening
8. Condizioni psichiatriche non controllate, tra cui, a titolo esemplificativo ma non esaustivo, depressione maggiore, disturbo bipolare, schizofrenia o disturbi schizoaffettivi. Sintomi come allucinazioni, deliri e psicosi sono motivo di esclusione.
9. Anomalie clinicamente significative nell’ECG o nei risultati clinici di laboratorio.
10. Il soggetto svolge un lavoro regolare che richiede turni notturni
11. I soggetti con programmi di viaggio/orari lavorativi che comportano cambiamenti di fuso orario significativi e frequenti (>2 ore) dovranno essere autorizzati all’arruolamento dal Responsabile del monitoraggio medico
12. Donne in stato di gravidanza o in fase di allattamento al seno
13. Uso di qualsiasi altro farmaco sperimentale a partire da 30 giorni o 5 emivite (a seconda di quale dei due periodi sia più lungo) prima dello screening fino al termine dello studio
14. Uso dei seguenti farmaci a partire da 30 giorni o 5 emivite (a seconda di quale dei due periodi sia più lungo) prima del Giorno 1 fino al termine dello studio:
a. rosiglitazone, inibitori dell’aromatasi, testosterone, ormoni della crescita o qualsiasi altro farmaco o integratore che potrebbe influire sulla sicurezza del soggetto o confondere l’interpretazione dei risultati dello studio;
b. i farmaci:
i. inibitori e/o induttori da moderati a forti del citocromo P450 3A4 (CYP3A4);
ii. substrati sensibili o substrati a intervallo terapeutico ristretto di CYP3A4 (ad eccezione di contraccettivi ormonali contenenti =20 µg di etinilestradiolo);
iii. substrati sensibili o substrati a intervallo terapeutico ristretto della proteina di resistenza del carcinoma mammario (BCRP) (ad eccezione di quelli che possono essere somministrati QD al mattino, a distanza di circa 10 ore dalla somministrazione
serale del farmaco dello studio).
15. Uso di anticoagulanti o terapie antipiastriniche diversi dall’aspirina nei 30 giorni precedenti lo screening
16. Anamnesi di disturbo emorragico attivo
17. Donazione o ricezione di sangue da 90 giorni prima dello screening fino al termine dello studio; donazione o ricezione di piastrine, globuli bianchi o plasma da 30 giorni prima dello screening fino al termine dello studio

E.5 End points

E.5.1

Primary end point(s)

Percentage change in A4 from Baseline to Week 18

Variazione percentuale nei livelli di A4 dal basale alla Settimana 18

E.5.1.1

Timepoint(s) of evaluation of this end point

Subjects blood will be collected at scheduled clinic visits at screening, during the run-in period Day 1 and Week 4, and during treatment period at Week 6, 10, 14, 18.

Campioni di sangue dei soggetti verranno raccolti a visite fissate durante il run-in period al giorno 1 e alla settimana 4, e durante il periodo di trattamento alla settimana 6, 10, 14 e 18.

E.5.2

Secondary end point(s)

Subjects who achieve the following at Week 18:
•A4 = ULN
•17-OHP = 4x ULN
•ACTH = ULN
Change from Baseline to Week 18 in the following:
•A4
•17-OHP
•ACTH

Variazione percentuale dal basale alla Settimana 18 nei livelli di:
•A4 = ULN
• 17-OHP = 4x ULN
• ACTH = ULN
I seguenti cambiamenti dal Baseline alla Settimana 18:
• A4
• 17-OHP
• ACTH

E.5.2.1

Timepoint(s) of evaluation of this end point

Subjects blood will be collected at scheduled clinic visits at screening, during the run-in period Day 1 and Week 4, and during treatment period at week 6, 10,14, 18.

Campioni di sangue dei soggetti verranno raccolti a visite fissate durante il run-in period al giorno 1 e alla settimana 4, e durante il periodo di trattamento alla settimana 6, 10, 14 e 18.

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

Biomarkers

Marcatori biologici

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

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

La parte C del trial sarà in aperto

Part C of the trial will be open label

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

Canada

United States

Denmark

Germany

Italy

Netherlands

Spain

Sweden

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

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.1.1.1

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)

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

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)

After the trial, the patient care will revert to their physicians

Dopo la sperimentazione, la cura del paziente tornerà ai loro medici curanti

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

2022-01-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-01-12

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

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Select Trial Status:	Select Trial Phase:
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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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