Clinical Trials Register

Summary
EudraCT Number:	2018-003206-58
Sponsor's Protocol Code Number:	CNTO1959PSO3013
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-15
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

2018-003206-58

A.3

Full title of the trial

A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

Uno studio di fase 3b, multicentrico, interventistico, randomizzato, controllato con placebo che valuta l’efficacia e la sicurezza di guselkumab per il trattamento della psoriasi non pustolosa palmoplantare

A.3.1

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

A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis

Uno studio per valuta l’efficacia e la sicurezza di guselkumab per il trattamento della psoriasi non pustolosa palmoplantare

A.3.2

Name or abbreviated title of the trial where available

G-PLUS

A.4.1

Sponsor's protocol code number

CNTO1959PSO3013

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	JANSSEN CILAG INTERNATIONAL NV
B.1.3.4	Country	Belgium
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	Janssen Pharmaceutica NV
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen Biologics B.V.
B.5.2	Functional name of contact point	Clinical Registry group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031715242166
B.5.5	Fax number	0031715242110
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	TREMFYA
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	GUSELKUMAB
D.3.2	Product code	[CNTO1959]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GUSELKUMAB
D.3.9.1	CAS number	1350289-85-8
D.3.9.2	Current sponsor code	CNTO1959
D.3.9.3	Other descriptive name	GUSELKUMAB
D.3.9.4	EV Substance Code	SUB179789
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	ANTICORPO MONOCLONALE

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	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Palmoplantar non-Pustular Psoriasis

Psoriasi non pustolosa palmoplantare

E.1.1.1

Medical condition in easily understood language

Psoriasis

Psoriasi

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	PT
E.1.2	Classification code	10037153
E.1.2	Term	Psoriasis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue 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 evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis

Valutare l’efficacia di guselkumab nel trattamento della psoriasi palmoplantare

E.2.2

Secondary objectives of the trial

•To evaluate the efficacy of guselkumab in improving work productivity and limitations in participants with palmoplantar psoriasis.
•To evaluate the efficacy of guselkumab in improving clinician assessments and disease related patient-reported quality-of-life measures in participants with palmoplantar psoriasis.
•To evaluate the efficacy, patient-reported quality-of-life assessments and other scores in the placebo-crossover group at different time points.
•To evaluate the efficacy, quality-of-life assessments and other scores in the placebo-crossover group at different time points.
•To evaluate the efficacy of guselkumab in improving work productivity and limitations in participants with palmoplantar psoriasis.
•To evaluate safety of guselkumab in participants with palmoplantar psoriasis.

- Valutare l’efficacia di guselkumab nel migliorare la produttività e le limitazioni sul lavoro nei partecipanti con psoriasi palmoplantare
-Valutare l'efficacia di guselkumab nel miglioramento delle valutazioni cliniche e delle misure relative alla qualità della vita riportate dai pazienti in relazione alla malattia nei partecipanti con psoriasi palmoplantare.
- Valutare l'efficacia, le valutazioni della qualità della vita riportate dal paziente e altri punteggi nel gruppo placebo-crossover in diversi punti temporali.
- Valutare efficacia, considerazioni sulla qualità della vita e altri punteggi nel gruppo crossover placebo in diversi momenti temporali
- Valutare l'efficacia di guselkumab nel migliorare la produttività del lavoro e le limitazioni nei partecipanti con psoriasi palmoplantare
- Valutare la sicurezza di guselkumab nei partecipanti con psoriasi palmoplantare

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participant population-related inclusion criteria
1. Male or female =18 years of age.
2. Should have a confirmed diagnosis of moderate-to-severe palmoplantar non-pustular psoriasis with palm and/or sole involvement and at least 1 plaque at a body site other than the palms, and soles for at last 6 months, to confirm a diagnosis of chronic of psoriasis.
-PASI score =3 and <10 at screening and at baseline
-ppIGA score =3 at screening and at baseline
3. Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included.
4. Willing to participate in the study.
Reproduction-related inclusion criteria
5. Before the first administration of guselkumab, a woman must be either:
• Not of childbearing potential
• Of childbearing potential and practicing a highly effective method of contraception
• User-dependent methods of contraception: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogenonly hormone contraception associated with inhibition of ovulation: oral and injectable
• Agree to remain on a highly effective method throughout the study and for at least 12 weeks after the last dose of study intervention.
6. A woman of childbearing potential must have a negative urine pregnancy test at Week 0.
7. A woman must agree not to donate eggs for the purposes of assisted reproduction from the first administration of study intervention through at least 12 weeks after receiving the last administration of guselkumab.
8. A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control, during the study and for at least 12 weeks after receiving the last administration of study intervention. All men must also agree to not donate sperm during the study and for at least 12 weeks after receiving the last administration of study intervention.
Infectious disease-related inclusion criteria
9. Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
10. Agree not to receive a BCG vaccination during the study, and within 12 months after the last administration of study intervention.
For full inclusion criteria, refer page number 21 to 24 of the protocol

Criteri di inclusione
Criteri di inclusione correlati alla popolazione di partecipanti
1. Uomo o donna di età pari o superiore a 18 anni.
2. Diagnosi confermata di psoriasi non pustolosa palmoplantare da moderata a grave con coinvolgimento della palma e / o della suola e almeno 1 placca in un sito del corpo diverso dai palmi e suole per almeno 6 mesi, per confermare una diagnosi di cronica della psoriasi.
-PASI punteggio =3 e <10 allo screening e al basale
-ppIGA punteggio =3 allo screening e al basale
3. Idoneità a ricevere trattamenti biologici; solo i partecipanti naive ai trattamenti biologici possono essere inclusi.
4. Intenzione di partecipare allo studio.
Criteri di inclusione correlati alla riproduzione
5. Prima della prima somministrazione di guselkumab, le donne devono rientrare in uno dei seguenti casi:
¿ Donne non potenzialmente fertili
¿ Donne potenzialmente fertili che utilizzano un metodo contraccettivo altamente efficace
¿ Metodi contraccettivi : contraccezione ormonale combinata (contenente estrogeni e progestinici) associata all'inibizione dell'ovulazione: orale, intravaginale e transdermica; contraccezione ormonale progestinica associata a inibizione dell'ovulazione: orale e iniettabile
¿ Consenso all’utilizzo di un metodo contraccettivo altamente efficace per l'intera durata dello studio e per almeno 12 settimane dopo l'ultima dose dell’intervento sperimentale.
6. Le donne in età fertile devono sottoporsi a un test di gravidanza sulle urine alla settimana 0 con esito negativo.
7. Le donne devono accettare di non donare ovuli (ovuli, ovociti) per scopi di riproduzione assistita dalla prima somministrazione dell’intervento dello studio fino ad almeno 12 settimane dopo l’ultima somministrazione di guselkumab.
8. Gli uomini sessualmente attivi con donne potenzialmente fertili e che non sono stati sottoposti a vasectomia devono acconsentire a usare un metodo contraccettivo di barriera
9. Consenso a non ricevere vaccinazioni con virus o batteri vivi durante lo studio o nelle 12 settimane successive all'ultima somministrazione dell’intervento dello studio. Per il vaccino Bacillus Calmette-Guerin (BCG), vedere criterio 11.
10. Consenso a non ricevere un vaccino BCG durante lo studio e nei 12 mesi successivi all'ultima somministrazione dell’intervento dello studio
Per la lista completa dei criteri di inclusione si prega di far riferimento alle pagine da 21 a 24 del protocollo di studio.

E.4

Principal exclusion criteria

Medical history-related exclusion criteria
1. Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than plaque-type psoriasis, or hyperkeratotic eczema.
2. Has current drug-induced psoriasis.
3. Has had major surgery within 8 weeks before screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the participant is expected to participate in the study.
4. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
5. Is pregnant, nursing, or planning a pregnancy while enrolled in this study, and for at least 12 weeks after the last administration of study intervention.
Concomitant or previous medical therapies-related exclusion criteria
6. Has used topical anti-psoriatic medications/treatments that could affect efficacy evaluations within 2 weeks of the planned first administration of study intervention.
7. Has received prior treatment with biological agents for palmoplantar-non-pustular psoriasis.
8. Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents.
10. Has previously MTX within 2 weeks, or Disease Modifying Anti Rheumatic Drugs , including cyclosporin, fumarates and Psoralen UVA.
For full exclusion criteria, refer page number 24 to 27 of the protocol

I potenziali partecipanti in possesso di uno qualsiasi dei criteri seguenti saranno esclusi dalla partecipazione allo studio:
Criteri di esclusione legati all’anamnesi medica
1. pustolosi palmoplantare, psoriasi pustolosa o qualsiasi altra forma diversa dalla psoriasi a placche o eczema ipercheratotico
2. Psoriasi indotta da farmaci (ad es. una nuova manifestazione di psoriasi o una esacerbazione della psoriasi da betabloccanti, bloccanti dei canali del calcio o litio) in atto.
3. Intervento chirurgico maggiore (che ha richiesto ad es. anestesia generale e ricovero in ospedale) entro le 8 settimane precedenti allo screening, mancata remissione completa dall’intervento chirurgico o intervento chirurgico in programma durante il periodo in cui è prevista la partecipazione allo studio.
Nota: i soggetti con procedure chirurgiche programmate da effettuarsi in anestesia locale possono partecipare.
4. Storia oppure segni o sintomi in atto di disturbi renali, cardiaci, vascolari, polmonari, gastrointestinali, endocrini, neurologici, ematologici, reumatologici, psichiatrici o metabolici giudicati gravi, progressivi o incontrollati.
5. Stato di gravidanza o allattamento o sta pianificando una gravidanza durante la partecipazione a questo studio e per almeno 12 settimane dopo l'ultima somministrazione dell'intervento di studio.
Criteri di esclusione correlati a terapie mediche concomitanti o precedenti
6. Ha utilizzato farmaci / trattamenti antipsoriatici topici che potrebbero influenzare le valutazioni di efficacia entro 2 settimane dalla prima somministrazione prevista dell'intervento.
7. Precedente trattamento con agenti biologici per psoriasi non pustolosa palmoplantare.
8. Precedente esposizione, intolleranza nota e riferita a guselkumab o relativi eccipienti oppure mancata idoneità al trattamento con agenti biologici.
10. Assunzione di MTX entro 2 settimane o farmaci anti reumatici modificanti la malattia, tra cui ciclosporina, fumarati e Psoralen UVA.
Per la lista completa dei criteri di inclusione si prega di far riferimento alle pagine da 24 a 27 del protocollo di studio.

E.5 End points

E.5.1

Primary end point(s)

Proportion of ppPASI75 responders in the guselkumab group versus the placebo group at Week 16

Proporzione di soggetti con risposta ppPASI75 nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

settimana 16

E.5.2

Secondary end point(s)

Change from baseline in BSA e absolute PASI scores, and percentage change in PASI score (PASI 75,90 and 100) in the guselkumab group at Weeks 24 and 48; Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group versus the placebo group at Week 16; Change from baseline in f-PGA scores in the guselkumab group versus the placebo group at Week 16; Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group at Weeks 24 and 48; Change from baseline in f-PGA scores in the guselkumab group at Weeks 24 and 48; Change from baseline in BSA, PASI and absolute ppPASI75 scores in the guselkumab group versus the placebo group at Week 16; DLQI, ppQLI, EQ-5D-5L, ppIGA, f-PGA, WPAI:PSO, NRS:P at Weeks 24and 48; Change from baseline in ppPASI scores in the guselkumab group at Weeks 24 and 48; Change from baseline in WPAI:PSO and NRS:P scores in the guselkumab group versus the placebo group at Week 16; Change from baseline in WPAI:PSO and NRS:P scores in the guselkumab group at Weeks 24 and 48; Rate of adverse events in the guselkumab and placebo/placebocrossover groups

Change from baseline in BSA and absolute PASI scorer, and percentage chenge in PASI scores (PASI 75,90 and 100) in the guselkumab group versus the placebo group at Week 16; Variazione dalla baseline dei punteggi BSA e PASI assoluto, e percerntuale di cambiamento nel punteggio di PASI nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16; Variazione dalla baseline dei punteggi BSA E PASI assoluto, e percentuale di cambiamento dei punteggi PASI (PASI 75,90 e 100) nel gruppo guselkumab alle Settimane 24 e 48; Variazione dalla baseline dei punteggi ppQLI, DLQI, EQ-5D-5L e ppIGA nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16; Variazione dalla baseline dei punteggi f-PGA nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16; Variazione dalla baseline dei punteggi ppQLI, DLQI, EQ-5D-5L e ppIGA nel gruppo guselkumab alle Settimane 24 e 48; Variazione dalla baseline dei punteggi f-PGA nel gruppo guselkumab alle Settimane 24 e 48; Variazione dalla baseline dei punteggi BSA, PASI assoluto e ppPASI75 nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16; DLQI, ppQLI, EQ-5D-5L, ppIGA, f-PGA, WPAI:PSO, NRS:P Settimane 24 e 48; Variazione rispetto al basale nei punteggi ppPASI nel gruppo guselkumab alle Settimane 24 e 48; Variazione rispetto al basale nel WPAI: punteggi PSO e NRS: P nel gruppo guselkumab rispetto al gruppo placebo alla settimana 16; Variazione rispetto al basale nei punteggi WPAI: PSO e NRS: P nel gruppo guselkumab alle settimane 24 e 48; Tasso di eventi avversi nei gruppi guselkumab e crossover placebo/placebo

E.5.2.1

Timepoint(s) of evaluation of this end point

week 16; Weeks 24 and 48; week 16; week 16; week 24 and 48; Weeks 24 and 48; Week 16; Weeks 24 and 48; Weeks 24 and 48; Weeks 16; Weeks 24 and 48; intero periodo di studio

settimana 16; settimana 24 e 48; settimana 16; Settimana 16; Settimana 24 e48; Settimane 24 e 48; Settimana 16; Settimane 24 e 48; Settimane 24 e 48; Settimane 16; Settimane 24 e 48; intero periodo di studio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarker analysis and Tolerability

Valutazione dei biomarcatori e Tollerabilità

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

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

LVLS

LPLV

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

105

F.4.2.2

In the whole clinical trial

105

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

nessuno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-07-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-16

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

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