Clinical Trials Register

Summary
EudraCT Number:	2018-002146-37
Sponsor's Protocol Code Number:	INCB50465-208
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-11-04
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

2018-002146-37

A.3

Full title of the trial

A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris

Studio di fase 2 di incremento progressivo della dose sulla sicurezza e la tollerabilità di INCB050465 nei partecipanti affetti da pemfigo volgare

A.3.1

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

A study to test if increasing doses of the drug INCB050465 is safe and well tolerated in patients with Pemphigus Vulgaris

Uno studio per verificare se le dosi crescenti del farmaco INCB050465 sono sicure e ben tollerate in pazienti con Pemfigo Vulgaris

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

INCB50465-208

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	INCYTE CORPORATION
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	Incyte Corporation
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	Incyte Corporation
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	1801 Augustine Cut-Off
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	DE 19803
B.5.3.4	Country	United States
B.5.4	Telephone number	0000000
B.5.5	Fax number	0013024252734
B.5.6	E-mail	RA@incyte.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.2.1.1.1	Trade name	NA
D.2.1.1.2	Name of the Marketing Authorisation holder	NA
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	INCB050465 1.0 mg
D.3.2	Product code	[NA]
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	INCB050465
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB183790
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	1
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	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	INCB050465 0.3 mg
D.3.2	Product code	[NA]
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	INCB050465
D.3.9.2	Current sponsor code	INCB050465
D.3.9.4	EV Substance Code	SUB183790
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	INCB050465 2.5mg
D.3.2	Product code	[NA]
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	INCB050465 HYDROCHLORIDE
D.3.9.2	Current sponsor code	INCB050465
D.3.9.4	EV Substance Code	SUB183790
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
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

Pemphigus vulgaris

Pemfigo Volgare

E.1.1.1

Medical condition in easily understood language

Pemphigus vulgaris

Pemfigo Volgare

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10052802
E.1.2	Term	Pemphigus vulgaris
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the safety and tolerability of INCB050465 in participants with pemphigus vulgaris

Valutare la sicurezza e la tollerabilità di INCB050465 nei partecipanti affetti da pemfigo volgare

E.2.2

Secondary objectives of the trial

To determine the systemic exposure to INCB050465

Determinare l’esposizione sistemica a INCB050465.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men and women aged 18 to 80 years at the time of consent.

2. Clinically documented and confirmed diagnosis of pemphigus vulgaris:
a. Minimum of 6 months of pemphigus vulgaris diagnosis
b. Positive for anti-DSG1 or DSG-3
c. PDAI score of 8 to 45 points
d. Have active skin, scalp, or mucosal lesions

3. Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment. There is no limit to the number of prior treatment regimens.

4. Willingness to avoid pregnancy or fathering children based on the criteria below.
a. Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed.
b. Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
c. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal, defined as = 12 months of amenorrhea before screening, confirmed by FSH levels at screening) are eligible.

5. If required, willing to receive PJP prophylaxis during the study period.

1. Uomini e donne di età compresa tra 18 e 80 anni al momento del consenso.

2. Diagnosi di pemfigo volgare clinicamente documentata e confermata:
a. Minimo 6 mesi dalla diagnosi di pemfigo volgare
b. Esito positivo per anti-DSG1 o DSG-3
c. Punteggio PDAI da 8 a 45 punti
d. Presentano lesioni attive cutanee, del cuoio capelluto o mucosali

3. Partecipanti che presentano una progressione della malattia dopo il trattamento con terapie standard note per apportare un beneficio clinico o che sono intolleranti al trattamento. Non esiste un limite al numero di precedenti regimi di trattamento.

4. La disponibilità a evitare la gravidanza o a procreare sulla base dei seguenti criteri.
a. Gli uomini devono accettare di adottare precauzioni atte a evitare di procreare (con una certezza di almeno il 99%) dallo screening fino a 90 giorni dopo l'ultima dose del farmaco dello studio e devono evitare di donare sperma durante questo periodo. I metodi consentiti che hanno un’efficacia anticoncezionale almeno del 99% (vedere l'appendice A) devono essere comunicati ai partecipanti che devono confermare di averli compresi.
b. Le donne in grado di procreare devono sottoporsi a un test di gravidanza sierologico con esito negativo allo screening e prima della prima dose al Giorno 1 e devono accettare di adottare precauzioni atte a evitare una gravidanza (con una certezza di almeno il 99%) dallo screening al follow-up per la sicurezza. I metodi consentiti che hanno un’efficacia anticoncezionale almeno del 99% devono essere comunicati ai partecipanti che devono confermare di averli compresi.
c. Le donne fisiologicamente incapaci di restare incinte (ossia chirurgicamente sterili in seguito a isterectomia e/o ovariectomia bilaterale OPPURE in post-menopausa definita come = 12 mesi di amenorrea prima dello screening, confermata dai livelli di FSH allo screening) sono idonee.

5. Se richiesto, disponibilità a ricevere profilassi per la PJP durante il periodo dello studio

E.4

Principal exclusion criteria

1. Pregnant or breast-feeding female.
2. Participants with pemphigus vulgaris who are treatment-naive.
3. Use of the following medications within the following periods before baseline:
a. 2 weeks:
i. Potent systemic CYP3A4 inhibitors and inducers or fluconazole.
ii. Topical treatment of pemphigus vulgaris lesions that may affect the disease assessment activities (eg, corticosteroids or tacrolimus/pimecrolimus).
b. 4 weeks: Systemic immunosuppressive (eg, cyclophosphamide and methotrexate), etanercept, anakinra, prednisone > 0.5 mg/kg per day (or oral corticosteroid equivalent dose).
c. 12 weeks or 5 half-lives (whichever is longer): infliximab, adalimumab, golimumab, abatacept, tocilizumab, certolizumab, secukinumab, IVIG, plasmapheresis, or any other biologic or experimental treatment.
d. 12 months: Anti-CD20 monoclonal antibody, for example, rituximab and ofatumumab.
4. Evidence or history of clinically significant infection or medical condition including the following:
a. Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of pemphigus vulgaris.
b. Chronic or ongoing infectious disease requiring long-term systemic treatment, including but not limited to chronic renal infection or chronic pulmonary infection with bronchiectasis.
c. Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study.
d. Positive test result for TB from the QuantiFERON®-TB Gold test or T-SPOT.TB test at screening (or, if 2 indeterminate tests, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening).
e. A history of active TB (treated or untreated) or history of untreated latent TB.
f. Positive serology test results for HIV, HBsAg, HBV core antibody, or HCV (HCV antibody with positive HCV-RNA) at screening.
g. Received live vaccine within 4 weeks before baseline or planning to receive live vaccine during the course of the study or within 4 weeks after EOT.
h. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as > 470 milliseconds for male and > 480 milliseconds for females.
i. History of malignancy within 5 years before baseline, other than a successfully treated nonmetastatic neoplasms (eg, cutaneous squamous cell carcinoma, basal cell carcinoma, localized carcinoma in situ of the cervix, or melanoma in situ)
j. History of solid organ transplant.
k. Any serious illness or medical, physical, or psychiatric condition(s) that, in the opinion of the investigator, would pose a significant risk to the participant or interfere with the interpretation of safety, efficacy, or pharmacodynamic data.
5. Participants with laboratory values at screening, according to the Protocol
6. Known or suspected allergy to INCB050465 or any component of the study drug.
7. Known history of clinically significant drug or alcohol abuse in the last year before baseline.
8. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
9. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
10. Inability of the participant to comprehend or unwilling to sign the ICF.

1. Donne in gravidanza o allattamento.
2. Partecipanti affetti da pemfigo volgare naive al trattamento.
3. Utilizzo dei seguenti farmaci nei seguenti periodi prima del basale:
a. 2 settimane:
i. Potenti inibitori e induttori sistemici di CYP3A4 o fluconazolo.
ii. Il trattamento topico delle lesioni da pemfigo volgare che possono influire sulle attività di valutazione della malattia (ad es., corticosteroidi o tacolimus/pimecrolimus).
b. 4 settimane: Immunosoppressore sistemico (ad es., ciclofosfamide e metotrexato), etanercept, anakinra, prednisone > 0,5 mg/kg al giorno (o dose equivalente di corticosteroide orale).
c. 12 settimane o 5 emivite (a seconda di quale durata sia maggiore): infliximab, adalimumab, golimumab, abatacept, tocilizumab, certolizumab, secukinumab, IVIG, plasmaferesi o qualsiasi altro trattamento biologico o sperimentale.
d. 12 mesi: Anticorpo monoclonale anti-CD20, ad esempio rituximab e ofatumumab.

4. Evidenza o anamnesi di infezione clinicamente significativa o condizione medica incluso quanto segue:
a. Qualsiasi altra malattia o condizione cutanea attiva (ad es., infezione batterica, micotica o virale) che possa interferire con il decorso,
la gravità o le valutazioni del pemfigo volgare.
b. Malattia infettiva cronica o in corso che richiede un trattamento sistemico a lungo termine incluso, a titolo esemplificativo ma non esaustivo, infezione renale cronica o infezione polmonare cronica con bronchiectasia.
c. Infezione virale sistemica attiva o qualsiasi infezione virale attiva che, sulla base della valutazione clinica dello sperimentatore, renda il partecipante un candidato inadatto a partecipare allo studio.
d. Risultato positivo per la TB al test -TB Gold o T-SPOT.TB di QuantiFERON® allo screening (o, in caso di 2 test indeterminati, poi valutati da un test sul derivato proteico purificato, con un risultato di < 5 mm di indurimento entro 3 mesi dallo screening).
e. Anamnesi di TB attiva (trattata o non trattata) o anamnesi di TB latente non trattata.
f. Risultati positivi dell’esame sierologico per HIV, HBsAg, anticorpo anti-core HBV o HCV (anticorpo anti HCV con HCV-RNA positivo) allo screening.
g. Ha ricevuto un vaccino vivo nelle 4 settimane precedenti il basale o pianifica di ricevere un vaccino vivo nel corso dello studio o entro 4 settimane dall'EOT.
h. Intervallo QT prolungato corretto per frequenza cardiaca utilizzando la formula di Fridericia (QTcF), definito come > 470 millisecondi per gli uomini e > 480 millisecondi per le donne.
i. Anamnesi di neoplasia maligna nei 5 anni precedenti il basale, ad eccezione di una neoplasia non metastatica trattata con esito positivo (ad es., carcinoma cutaneo a cellule squamose, carcinoma a cellule basali, carcinoma in situ della cervice o melanoma in situ)
j. Anamnesi di trapianto di organo solido.
k. Qualsiasi malattia grave o condizione/i di natura medica, fisica o psichiatrica che, secondo l’opinione dello sperimentatore, rappresenterebbe un rischio significativo per il partecipante o interferirebbe con l'interpretazione dei dati di sicurezza, efficacia o farmacodinamica.

5. Partecipanti con valori di laboratorio allo screening in accordo al protocollo
6. Allergia nota o sospetta a INCB050465 o a qualsiasi componente del farmaco dello studio.
7. Precedenti noti di abuso clinicamente significativo di droghe o alcool nell’ultimo anno prima del basale.
8. Partecipante incapace o restio ad aderire allo schema posologico e alle valutazioni dello studio, secondo l’opinione dello sperimentatore.
9. Qualsiasi condizione che, secondo il giudizio dello sperimentatore, interferirebbe con la piena partecipazione allo studio, inclusa la somministrazione del farmaco dello studio e la presenza richiesta alle visite dello studio, rappresenterebbe un rischio significativo per il partecipante; o interferirebbe con l’interpretazione dei dati dello studio.
10. Partecipante incapace di comprendere o che non intende firmare il modulo di consenso informato.

E.5 End points

E.5.1

Primary end point(s)

• Frequency, duration, and severity of AEs, clinical laboratory test results, vital signs results, ECGs, and physical examination findings.

• Frequenza, durata e gravità di EA, risultati dei test clinici di laboratorio, risultati dei parametri vitali, ECG ed esiti degli esami obiettivi.

E.5.1.1

Timepoint(s) of evaluation of this end point

Throughout the study

Durante lo studio

E.5.2

Secondary end point(s)

• Assessment of Cmax, tmax, Cmin, AUC0-t, and CL/F.

• Valutazione di Cmax, tmax, Cmin, AUC0-t e CL/F.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1, week 2, week 6

giorno 1, settimana 2, settimana 6

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

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

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

Canada

France

Italy

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.1.1.1

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)

None

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

2019-03-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-11-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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