Clinical Trials Register

Summary
EudraCT Number:	2020-003130-21
Sponsor's Protocol Code Number:	INCB50465-313
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-04
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-003130-21

A.3

Full title of the trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kd Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

Studio di fase 3, randomizzato, in doppio cieco, controllato verso placebo sulla combinazione dell’inibitore di PI3Kd parsaclisib e di ruxolitinib in partecipanti affetti da mielofibrosi

A.3.1

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

A phase 3 study of parsaclisib plus ruxolitinib in patients with myelofibrosis

Studio di fase 3 su parsaclisib più ruxolitinib in pazienti affetti da mielofibrosi

A.3.2

Name or abbreviated title of the trial where available

INCB50465-313

A.4.1

Sponsor's protocol code number

INCB50465-313

A.5.4

Other Identifiers

Name:

IND number

Number:

147,207

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	+13024986700
B.5.5	Fax number	+13024252734
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.2.5	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	parsaclisib
D.3.2	Product code	[INCB050465]
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	parsaclisib
D.3.9.1	CAS number	1426698-88-5
D.3.9.2	Current sponsor code	INCB050465
D.3.9.3	Other descriptive name	PARSACLISIB HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB193469
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	parsaclisib
D.3.2	Product code	[INCB050465]
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	parsaclisib
D.3.9.1	CAS number	1426698-88-5
D.3.9.2	Current sponsor code	INCB050465
D.3.9.3	Other descriptive name	PARSACLISIB HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB193469
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	5
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	parsaclisib
D.3.2	Product code	[INCB050465]
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	parsaclisib
D.3.9.1	CAS number	1426698-88-5
D.3.9.2	Current sponsor code	INCB050465
D.3.9.3	Other descriptive name	PARSACLISIB HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB193469
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	2
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: 4
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	Jakavi 5 mg compresse
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	EU/3/08/572
D.3 Description of the IMP
D.3.1	Product name	Jakavi 5 mg tablets
D.3.2	Product code	[Jakavi 5 mg tablets]
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	RUXOLITINIB
D.3.9.1	CAS number	941678-49-5
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	RUXOLITINIB
D.3.9.4	EV Substance Code	SUB32273
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	5
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
D.8 Placebo: 2
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
D.8 Placebo: 3
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

myelofibrosis

mielofibrosi

E.1.1.1

Medical condition in easily understood language

myelofibrosis

mielofibrosi

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

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	10028537
E.1.2	Term	Myelofibrosis
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 and compare the efficacy of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib on spleen volume at Week 24.

Valutare e confrontare l’efficacia di parsaclisib più ruxolitinib rispetto al placebo più ruxolitinib sul volume della milza alla settimana 24.

E.2.2

Secondary objectives of the trial

* To evaluate and compare the effect of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib on participant reports of MF symptoms.
* To evaluate and compare the effect of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib with respect to OS.
* To evaluate and compare the safety and tolerability of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib.

* Valutare e confrontare l’effetto di parsaclisib più ruxolitinib rispetto al placebo più ruxolitinib sulle segnalazioni dei sintomi di MF da parte dei partecipanti.
* Valutare e confrontare l’effetto di parsaclisib più ruxolitinib rispetto al placebo più ruxolitinib in relazione alla sopravvivenza globale (OS, Overall Survival).
* Valutare e confrontare la sicurezza e la tollerabilità di parsaclisib più ruxolitinib rispetto al placebo più ruxolitinib.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men and women aged 18 years or older;
2. Diagnosis of PMF, PPV-MF, or PET-MF;
3. DIPSS risk category of intermediate-1, intermediate-2, or high;
4. Evidence of need for treatment for MF (both a and b must be
satisfied):
a. Palpable spleen of = 5 cm below the left costal margin on physical
examination at the screening visit
b. Active symptoms of MF at the screening visit, as demonstrated by the
presence of a TSS of = 10 using the Screening Symptom Form
5. ECOG performance status score of 0, 1, or 2.
For the complete list of inclusion criteria please refer to the protocol, section 5.1

1. Uomini e donne di età pari o superiore a 18 anni;
2. Diagnosi di PMF, PPV-MF o PET-MF;
3. Categoria di rischio DIPSS intermedio-1, intermedio-2 o alto;
4. Prova della necessità di cure per la MF (devono essere sia a che b
soddisfatto):
a. Milza palpabile di = 5 cm sotto il margine costale sinistro sul piano fisico
esame alla visita di screening
b. Sintomi attivi di MF alla visita di screening, come dimostrato dal
presenza di un TSS di = 10 utilizzando lo Screening Symptom Form
5. Punteggio di performance status ECOG pari a 0, 1 o 2.
Per l'elenco completo dei criteri di inclusione, fare riferimento al protocollo, sezione 5.1

E.4

Principal exclusion criteria

1. Prior use of any JAK inhibitor.
2. Prior therapy with any drug that inhibits PI3K
3. Use of experimental drug therapy for MF or any other standard drug (eg, danazol, hydroxyurea) used for MF within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to = Grade 1.
4. Inability to swallow food or any condition of the upper
gastrointestinal tract that precludes administration of oral medications
5. Recent history of inadequate bone marrow reserve
For the complete list of exclusion criteria please refer to the protocol, section 5.2

1. Uso precedente di qualsiasi inibitore JAK.
2. Terapia precedente con qualsiasi farmaco che inibisce PI3K
3. Uso della terapia farmacologica sperimentale per MF o qualsiasi altro farmaco standard (ad esempio, danazolo, idrossiurea) utilizzato per MF entro 3 mesi dall'inizio farmaco in studio e / o mancanza di recupero da tutte le tossicità precedenti terapia fino a = grado 1.
4. Incapacità di ingoiare cibo o qualsiasi condizione della tomaia tratto gastrointestinale che preclude la somministrazione di farmaci orali
5. Storia recente di riserva di midollo osseo inadeguata
Per l'elenco completo dei criteri di esclusione fare riferimento al protocollo, sezione 5.2

E.5 End points

E.5.1

Primary end point(s)

Proportion of participants achieving >= 35% reduction in spleen volume from baseline to Week 24 as measured by MRI (or CT scan in applicable participants).

Percentuale di partecipanti che hanno raggiunto una riduzione >= 35% del volume della milza dal basale alla settimana 24, misurata mediante risonanza magnetica (o TC nei partecipanti applicabili).

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

settimana 24

E.5.2

Secondary end point(s)

* Proportion of participants who have a = 50% reduction in TSS from baseline to Week 24 as measured by the MFSAF v4.0 diary.
* Change in TSS from baseline to Week 24 as measured by the MFSAF v4.0 diary.
* Time to the first = 50% reduction in TSS as measured by the MFSAF v4.0 diary.
* OS determined from the date of randomization until death due to any cause.
* Safety and tolerability

* Percentuale di partecipanti che hanno una riduzione del TSS = 50% da dal basale alla settimana 24 misurata dal diario MFSAF v4.0.
* Variazione del TSS dal basale alla settimana 24 misurata dall'MFSAF diario v4.0.
* Tempo alla prima riduzione = 50% della TSS misurata dall'MFSAF diario v4.0.
* OS determinato dalla data di randomizzazione fino alla morte per qualsiasi motivo causa.
* Sicurezza e tollerabilità

E.5.2.1

Timepoint(s) of evaluation of this end point

* Proportion of participants with = 50% reduction in TSS: week 24
* Change in TSS: week 24
* Time to the first = 50% reduction in TSS:
* OS: throughout the study
* Safety and tolerability: throughout the study

* Proporzione di partecipanti con riduzione = 50% del TSS: settimana 24
* Modifica del TSS: settimana 24
* Tempo alla prima riduzione = 50% del TSS:
* OS: durante lo studio
* Sicurezza e tollerabilità: durante tutto lo 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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

China

Japan

United States

Austria

Belgium

Denmark

Finland

France

Germany

Hungary

Ireland

Italy

Norway

Poland

Spain

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:

158

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

282

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

181

F.4.2.2

In the whole clinical trial

440

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 24 weeks, participants will enter the extension period of the study. Treatment will continue as long as it is tolerated and the participant does not meet discontinuation criteria.
Participants randomized to placebo will have the opportunity to crossover to receive parsaclisib (with continued ruxolitinib) once they have reached Week 24. Crossover participants may also continue as long as the regimen is tolerated and they do not meet discontinuation criteria.

Dopo 24 settimane, i partecipanti entreranno nel periodo di estensione dello studio. Il trattamento continuerà finché è tollerato e il partecipante non soddisfa i criteri di interruzione.
I partecipanti randomizzati al placebo avranno l'opportunità di passare al cross-over per ricevere parsaclisib (con ruxolitinib continuato) una volta raggiunta la settimana 24. I partecipanti al crossover possono anche continuare fintanto che il regime è tollerato e non soddisfano i criteri di sospensione.

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

2021-03-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-27

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

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