Clinical Trials Register

Summary
EudraCT Number:	2019-000176-41
Sponsor's Protocol Code Number:	341-201-00004
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:	2020-11-05
Trial results	View 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-000176-41

A.3

Full title of the trial

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment

Studio proof-of-concept di fase 2, multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare l’efficacia e la sicurezza di OPS-2071 somministrato per via orale per 12 settimane a soggetti con malattia di Crohn che mostrano sintomi di infiammazione attiva nonostante il trattamento in corso

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

341-201-00004

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03850509

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	Otsuka Pharmaceutical Development and Commercialization, 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	Otsuka Pharmaceutical Development & Commercialization, 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	Otsuka Pharmaceutical Development & Commercialization, Inc.
B.5.2	Functional name of contact point	Kimberly Sikes
B.5.3	Address:
B.5.3.1	Street Address	2440 Research Boulevard
B.5.3.2	Town/ city	Rockville
B.5.3.3	Post code	Maryland 20850
B.5.3.4	Country	United States
B.5.4	Telephone number	12407804266
B.5.5	Fax number	13017218592
B.5.6	E-mail	kimberly.sikes@otsuka-us.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	OPS-2071
D.3.2	Product code	[OPS-2071]
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	OPS-2071
D.3.9.1	CAS number	1426216-93-4
D.3.9.2	Current sponsor code	OPS-2071
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	150
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	OPS-2071
D.3.2	Product code	[OPS-2071]
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	OPS-2071
D.3.9.1	CAS number	1426216-93-4
D.3.9.2	Current sponsor code	OPS-2071
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	300
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	OPS-2071
D.3.2	Product code	[OPS-2071]
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	OPS-2071
D.3.9.1	CAS number	1426216-93-4
D.3.9.2	Current sponsor code	OPS-2071
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	300
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.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
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

Crohn's Disease

Malattia di Crohn

E.1.1.1

Medical condition in easily understood language

Crohn's disease

Malattia di Crohn

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10011401
E.1.2	Term	Crohn's disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

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 investigate the therapeutic effect of OPS-2071 (150, 300, or 600 mg twice a day [BID]) add-on therapy administered orally for 12 weeks in subjects with Crohn’s disease showing symptoms of active inflammation despite ongoing treatment.

Esaminare l’efficacia terapeutica della terapia aggiuntiva con OPS-2071 (150, 300 o 600 mg due volte al giorno [BID]) somministrato per via orale per 12 settimane in soggetti affetti da malattia di Crohn che mostrano sintomi di infiammazione attiva nonostante il trattamento in corso.

E.2.2

Secondary objectives of the trial

To determine the safety and tolerability of OPS-2071 (150, 300, or 600 mg BID) add-on therapy administered orally for 12 weeks in subjects with Crohn’s disease showing symptoms of active inflammation despite ongoing treatment.

Stabilire la sicurezza e la tollerabilità della terapia aggiuntiva con OPS-2071 (150, 300 o 600 mg BID) somministrato per via orale per 12 settimane in soggetti affetti da malattia di Crohn che mostrano sintomi di infiammazione attiva nonostante il trattamento in corso.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Diagnosis of Crohn's disease localized in the ileum and/or colon, with active mucosal inflammation and visible
lesion(s), documented by centrally read ileocolonoscopy and a Simple Endoscopic Score for Crohn’s Disease
(SES-CD) = 6 (= 4 for isolated ileal disease).
2) Subjects who do not have an optimal response (daily stool frequency > 3 and pain score > 1) to their current ongoing
treatment of biologics (eg, first anti-tumor necrosis factor-alpha [TNF-a] monoclonal antibody), immunosuppressants, low-dose steroids, or 5-aminosalicylic acid (5-ASA) formulations.
3) Subjects who are on stable Crohn’s disease medications for at least 4 weeks.
4) Subjects with a CDAI score between 180 and 450 points, inclusive.

1) Diagnosi di malattia di Crohn localizzata nell’ileo e/o colon, con infiammazione attiva delle mucose e lesione/i visibile/i, documentate mediante ileocolonscopia letta a livello centrale e un punteggio endoscopico semplificato per la malattia di Crohn (SES-CD) = 6 (= 4 per malattia ileale isolata).
2) Soggetti che non presentano una risposta ottimale (frequenza di evacuazione giornaliera > 3 e punteggio del dolore > 1) al trattamento in corso con farmaci biologici (ad es. anticorpi monoclonali contro il fattore di necrosi tumorale [TNF-a]), immunosoppressori, steroidi a basso dosaggio o preparati a base di acido 5 aminosalicilico (5-ASA).
Nota: La durata minima del trattamento precedente, richiesta affinché un soggetto possa essere considerato come avente una risposta non ottimale, comprende l’aver completato almeno il regime di induzione raccomandato per i farmaci biologici approvati e/o il trattamento a una dose terapeutica per una durata stabile e con il quale sarebbe prevedibile un miglioramento (ovvero 12 settimane di azatioprina, 4 settimane di metotrexato).
3) Soggetti che assumono farmaci per la cura della malattia di Crohn su base stabile da almeno 4 settimane.
4) Soggetti con un punteggio CDAI compreso tra 180 e 450 punti, inclusi.

E.4

Principal exclusion criteria

1) Low-dose steroids may be tapered down during the trial, based on inflammatory biomarkers and the investigator’s judgment.
2) Use of prednisone or prednisolone > 30 mg/day or budesonide > 9 mg/day within 4 weeks prior to screening; or intravenous steroids within 4 weeks prior to screening.
3) Subjects with known or suspected (family history, unexplained syncope) long QT syndrome or QT interval corrected for heart rate by the Fridericia formula (QTcF) > 470 msec for females or > 450 msec for males at baseline.
4) Subjects with known existing aortic aneurysm, or who are at risk for an aortic aneurysm, such as subjects with
peripheral atherosclerotic vascular diseases, uncontrolled hypertension, certain genetic conditions such as Marfan
syndrome and Ehlers-Danlos syndrome, and elderly subjects (over the age of 70).
5) Subjects with inadequate organ function, as follows: Serum creatinine > 1.5 x the upper limit of normal (ULN); Aspartate aminotransferase or alanine aminotransferase levels > 1.5 x ULN; Total bilirubin > 1.5 x ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.
6) Known hypersensitivity to quinolones.
7) Subjects with a history of treatment failure with 2 or more biologics.
8) Subjects with risk factors for tendon rupture (ie, psoriasis, ankylosing spondylitis, competitive athletes, renal failure,
diabetes mellitus) or who have a history of tendon rupture and/or ongoing tendinopathy.
9) Subjects with systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg.
10) Subjects taking quinidine, procainamide, disopyramide, encainide, flecainide, sotalol, amiodarone, ibutilide, dronedarone, or propafenone.

1) Gli steroidi a basso dosaggio possono essere ridotti durante lo studio, sulla base dei biomarcatori infiammatori e del giudizio dello sperimentatore.
2) Uso di prednisone o prednisolone > 30 mg/giorno o budesonide > 9 mg/giorno nelle 4 settimane precedenti lo screening; oppure steroidi somministrati per via endovenosa nelle 4 settimane precedenti lo screening.
3) Soggetti con nota o sospetta (anamnesi familiare, sincope inspiegata) sindrome del QT lungo o intervallo QT corretto per la frequenza cardiaca mediante la formula di Fridericia (QTcF) > 470 msec per i soggetti di sesso femminile o > 450 msec per gli uomini al basale.
4) Soggetti con noto aneurisma aortico preesistente o che sono a rischio di aneurisma aortico, come i soggetti con malattie vascolari periferiche aterosclerotiche, ipertensione non controllata, determinate condizioni genetiche quali la sindrome di Marfan e la sindrome di Ehlers-Danlos, nonché i soggetti anziani (di età superiore ai 70 anni).
5) Soggetti con inadeguata funzionalità d’organo, così come segue:
• Creatinina sierica > 1,5 ¿¿il limite superiore della norma (ULN)
• Livelli di aspartato aminotransferasi o di alanina aminotransferasi > 1,5 ¿¿ULN.
• Bilirubina totale > 1,5 ¿¿ULN. Sono consentiti livelli elevati di bilirubina non coniugata correlati alla sindrome di Gilbert.
6) Ipersensibilità nota ai chinoloni o altra reazione avversa significativa ai chinoloni.
7) Soggetti con anamnesi di fallimento al trattamento con 2 o più farmaci biologici.
8) Soggetti con fattori di rischio per la rottura dei tendini (vale a dire, psoriasi, spondilite anchilosante, atleti agonisti, insufficienza renale, diabete mellito), o che presentano un’anamnesi di rottura dei tendini e/o tendinopatia in corso.
9) Soggetti con pressione arteriosa sistolica > 150 mmHg o pressione arteriosa diastolica > 90 mmHg.
10) Soggetti che assumono chinidina, procainamide, disopiramide, encainide, flecainide, sotalolo, amiodarone, ibutilide, dronedarone o propafenone.

E.5 End points

E.5.1

Primary end point(s)

The percentage of subjects who, at Week 12, achieve clinical remission (defined as a CDAI score < 150).

Percentuale di soggetti che, alla Settimana 12, raggiungono la remissione clinica (definita come un punteggio CDAI < 150).

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

Settimana 12

E.5.2

Secondary end point(s)

Efficacy endpoints:
1) The percentage of subjects with endoscopic response, defined as a reduction of the SES-CD by at least 50%, at Week 12.
2) Change from baseline in the SES-CD score.
3) The percentage of subjects with PRO-2 remission (defined as stool frequency = 3 times per day and abdominal pain = 1) at Week 12.
4) The percentage of subjects with clinical response, defined as at least a 25% decrease in the CDAI score, at Week 12.
5) The percentage of subjects who, at Week 12, achieve endoscopic remission (defined as a SES-CD score of 0 to 2; or a score of 0 to 4, with no individual subscore greater than 1).
6) The percentage of subjects with a decrease from baseline of = 100 points in the CDAI score.

Safety endpoints:
The percentage of subjects by specific AEs, which will be recorded with the onset date, resolution or stabilization date, severity grade, and relatedness to IMP.

1) Percentuale di soggetti con risposta endoscopica, definita come una riduzione del SES-CD di almeno il 50%, alla Settimana 12.
2) Variazione rispetto al basale nel punteggio SES-CD.
3) Percentuale di soggetti con remissione PRO-2 (definita come frequenza delle feci = 3 volte al giorno e dolore addominale = 1), alla Settimana 12.
4) Percentuale di soggetti con risposta clinica, definita come una diminuzione di almeno il 25% nel punteggio CDAI, alla Settimana 12.
5) Percentuale di soggetti che, alla Settimana 12, raggiungono la remissione endoscopica (definita come punteggio SES-CD da 0 a 2; oppure punteggio da 0 a 4, senza sottopunteggio individuale superiore a 1).
6) Percentuale di soggetti con una riduzione rispetto al basale = 100 punti nel punteggio CDAI.

Endpoint secondari di sicurezza: percentuale di soggetti sulla base di EA specifici che saranno registrati secondo la data di insorgenza, la data di risoluzione o stabilizzazione, il grado di gravità e la relazione con l’IMP.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 12

Settimana 12

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Belgium

Canada

Germany

Italy

Poland

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of trial date is defined as the last date of contact from the 30-day post-treatment follow-up visit screen in eSource for the last subject completing or withdrawing from the trial.

La data di fine della sperimentazione è definita come l'ultima data di contatto dal 30 giorno visita di follow-up post-trattamento in eSource per l'ultimo soggetto che completa o si ritira dal processo.

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:

210

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

117

F.4.2.2

In the whole clinical trial

240

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)

Standard of care

Terapia standard

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

2020-02-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-19

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials