Clinical Trials Register

Summary
EudraCT Number:	2020-003123-42
Sponsor's Protocol Code Number:	INCB39110-213
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-02-01
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

Spain - AEMPS

A.2

EudraCT number

2020-003123-42

A.3

Full title of the trial

A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post–Polycythemia Vera Myelofibrosis or Post–Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapys

Estudio abierto de fase II de 2 partes de la seguridad, tolerabilidad y eficacia de la liberación inmediata de itacitinib en pacientes con mielofibrosis primaria o secundaria (mielofibrosis pospolicitemia vera o mielofibrosis postrombocitemia esencial) que han recibido ruxolitinib o fedratinib con anterioridad en monoterapia

A.3.1

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

A study evaluating safety, tolerability and efficacy of Itacitinib in participants with primary or secondary Myelofibrosis

A.4.1

Sponsor's protocol code number

INCB39110-213

A.5.4

Other Identifiers

Name:

IND Number

Number:

113,428

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	+1302498 5670
B.5.5	Fax number	+1302425 2734
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/17/1964
D.3 Description of the IMP
D.3.1	Product name	Itacitinib
D.3.2	Product code	INCB039110
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	Itacitinib
D.3.9.1	CAS number	1334298-90-6
D.3.9.2	Current sponsor code	INCB039110
D.3.9.3	Other descriptive name	ITACITINIB
D.3.9.4	EV Substance Code	SUB184194
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	100
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/17/1964
D.3 Description of the IMP
D.3.1	Product name	Itacitinib
D.3.2	Product code	INCB039110
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	Itacitinib
D.3.9.1	CAS number	1334298-90-6
D.3.9.2	Current sponsor code	INCB039110
D.3.9.3	Other descriptive name	ITACITINIB
D.3.9.4	EV Substance Code	SUB184194
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Primary Myelofibrosis or Secondary Myelofibrosis

mielofibrosis primaria o mielofibrosis secundaria

E.1.1.1

Medical condition in easily understood language

Primary Myelofibrosis or Secondary Myelofibrosis

mielofibrosis primaria o mielofibrosis secundaria

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

Part 1: To evaluate the safety and tolerability of itacitinib IR and select the RP2D for Part 2 of the study.
Part 2: To evaluate the efficacy of itacitinib IR at the RP2D with respect to spleen volume reduction at Week 24.

Parte 1: evaluar la seguridad y tolerabilidad de la liberación inmediata de itacitinib y seleccionar la DRFII para la parte 2 del estudio.
Parte 2: evaluar la eficacia de la liberación inmediata de itacitinib en la DRFII con respecto a la reducción del volumen del bazo en la semana 24.

E.2.2

Secondary objectives of the trial

Part 2:
- To evaluate the safety and tolerability of itacitinib IR at the RP2D.
- To evaluate the efficacy of itacitinib IR at the RP2D with respect to MF symptom improvement at Week 24, in those patients with a baseline TSS ≥ 10.
- To evaluate the efficacy of itacitinib IR with respect to improvement of quality of life.
- To evaluate the efficacy of itacitinib IR at the RP2D with respect to PGIC.

Parte 2:
- evaluar la seguridad y tolerabilidad de la liberación inmediata de itacitinib en la DRFII.
- evaluar la eficacia de la liberación inmediata de itacitinib en la DRFII con respecto a la mejora de los síntomas de la MF en la semana 24 en aquellos pacientes con un TSS de ≥ 10.
- evaluar la eficacia de la liberación inmediata de itacitinib con respecto a la mejora de la calidad de vida.
- evaluar la eficacia de la liberación inmediata de itacitinib en la DRFII con respecto a la PGIC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aged 18 years or older at the time of signing the informed consent.
2. Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria.
3. At least Intermediate 1 risk MF according to the DIPSS.
4. Prior treatment with ruxolitinib and/or fedratinib monotherapy:
a. Previously treated with ruxolitinib and/or fedratinib monotherapy for PMF or secondary MF for not more than 6 months if treatment was discontinued due to recurrent Grade 4 thrombocytopenia; ≥ Grade 3 anemia, hemorrhage, or hematoma; or allergy/other intolerance to ruxolitinib or fedratinib;
OR
b. Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF:
− For at least 3 months with initial response but regrowth of spleen on imaging or by palpation compared with baseline;
OR
− For at least 28 days if treatment is complicated by recurrent Grade 4 thrombocytopenia; ≥ Grade 3 anemia, hemorrhage, or hematoma; or allergy/other intolerance to ruxolitinib or fedratinib.
5. Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume ≥ 450 cm3 on imaging assessed during screening.
6. Allogeneic stem cell transplant not planned.
7. Platelet ≥ 50 × 109/L at screening.
8. Ability to comprehend and willingness to sign a written ICF for the study.
9. Willingness to avoid pregnancy or fathering children

1. 18 años de edad o más en el momento de firmar el consentimiento informado.
2. Diagnóstico de MF primaria que cumpla los criterios de la OMS de 2016 para MFP sintomática o MF secundaria (MF PPV o MF PET) que cumpla los criterios del Grupo de Trabajo Internacional para la Investigación y el Tratamiento de la Mielofibrosis (IWG-MRT) de 2008.
3. MF al menos de riesgo intermedio 1 conforme al DIPSS.
4. Tratamiento previo con ruxolitinib o fedratinib en monoterapia:
a. Tratamiento previo con ruxolitinib o fedratinib en monoterapia para la MFP o la MF secundaria durante 6 meses como máximo si el tratamiento se interrumpió por una trombocitopenia de grado 4 recurrente; anemia, hemorragia o hematoma de grado ≥ 3; o alergia u otra intolerancia al ruxolitinib o fedratinib;
O
b. Está recibiendo en este momento ruxolitinib o fedratinib en monoterapia para la MFP o la MF secundaria:
- Durante al menos 3 meses con respuesta inicial, pero se ha detectado un nuevo crecimiento del bazo en imágenes o mediante palpación en comparación con la visita inicial;
O
- Durante al menos 28 días si el tratamiento se ha complicado por una trombocitopenia de grado 4 recurrente; anemia, hemorragia o hematoma de grado ≥ 3; o alergia u otra intolerancia al ruxolitinib o fedratinib.
5. La esplenomegalia se define como un bazo palpable al menos 5 cm por debajo del reborde costal izquierdo o un volumen de ≥ 450 cm3 en imágenes determinado durante la selección.
6. Autotrasplante de células progenitoras no previsto.
7. Nivel de trombocitos de ≥ 50 x 109/l en la selección.
8. Capacidad de comprender y voluntad de firmar un FCI por escrito para el estudio.
9. Dispuesto a evitar el embarazo o a engendrar hijos, según los siguientes criterios.

E.4

Principal exclusion criteria

1. Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib.
2. Record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening.
3. For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents.
4. Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1.
5. Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib
6. Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement
7. Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study
8. ECOG performance status ≥ 3
9. Life expectancy less than 24 weeks
10. Not willing to receive RBC or platelet transfusions
11. Participants with laboratory values at screening defined in Table 11 of protocol
12. Significant concurrent, uncontrolled medical condition, including but not limited to the following: Gastrointestinal, Cardiovascular
13. History or presence of an abnormal ECG that, in the investigator’s opinion, is clinically meaningful according to the guidance provided in Section 8.3.4 of the protocol.
14. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
15. Hepatitis: Evidence of HBV or HCV infection or risk of reactivation.
16. Known HIV infection.
17. Current use of prohibited medication as described in Section 6.6.9 of protocol.
18. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
19. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
20. Women who are pregnant or breastfeeding.
21. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of itacitinib IR and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
22. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including: inability to self-administer itacitinib IR; difficulty attending required study visits; a comorbid condition that poses a significant risk to the participant or may interfere with interpretation of study data.
23. The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.

1. Tratamiento previo con un inhibidor de JAK distinto a ruxolitinib o fedratinib.
2. Registro de ≥ 10 % de mieloblastos en la sangre periférica (en frotis de sangre periférica) o la médula ósea antes o en el momento de la selección.
3. Para los participantes que reciben ruxolitinib o fedratinib, incapacidad de reducir gradualmente la dosis del tratamiento durante 14 días sin corticoesteroides, hidroxicarbamida u otros fármacos.
4. Tratamiento con ruxolitinib, fedratinib u otro tratamiento dirigido a la MF (aprobado o en investigación) en un plazo de 2 semanas desde el día 1.
5. Esplenectomía previa o irradiación esplénica en los 6 meses previos a la administración de la primera dosis de itacitinib.
6. Incapacidad o renuencia a someterse a una RM o TAC en serie para la medición del volumen del bazo.
7. Incapacidad o renuencia a completar el diario MFSAF versión 4.0 todos los días durante el estudio.
8. Estado funcional del ECOG de ≥ 3.
9. Esperanza de vida inferior a 24 semanas.
10. Renuencia a recibir transfusiones de eritrocitos o trombocitos.
11. Participantes con valores analíticos en la selección definidos en la 11 del protocolo.
12. Enfermedades significativas concurrentes no controladas, incluidas, entre otras, las siguientes: Gastrointestinales, Cardiovasculares.
13. Antecedentes o presencia de anomalías en el ECG que, en opinión del investigador, sean clínicamente significativas conforme a la orientación proporcionada en el apartado 8.3.4 del protocolo.
14. Enfermedad infecciosa crónica o activa en la actualidad que precise antibióticos sistémicos, antifúngicos o un tratamiento antivírico.
15. Hepatitis: indicios de infección por el VHB o el VHC, o riesgo de reactivación de la enfermedad.
16. Infección conocida por el VIH.
17. Uso actual de medicamentos prohibidos según se describe en el apartado 6.6.9 del protocolo.
18. Incapacidad o improbabilidad de que el participante cumpla la pauta posológica y las evaluaciones del estudio, en opinión del investigador.
19. Recuperación inadecuada de una toxicidad o de complicaciones derivadas de una cirugía mayor antes de comenzar el tratamiento.
20. Mujeres embarazadas o lactantes.
21. Cualquier alteración que, en opinión del investigador, interfiera con la plena participación en el estudio, incluida la administración de la liberación inmediata de itacitinib y la asistencia a las visitas del estudio obligatorias; que represente un riesgo significativo para el participante; o que interfiera con la interpretación de los datos del estudio.
22. Cualquier alteración que, en opinión del investigador, interfiera con la plena participación en el estudio, incluida: la incapacidad de autoadministrarse la liberación inmediata de itacitinib; la dificultad para asistir a las visitas del estudio obligatorias; una enfermedad concomitante que suponga un riesgo significativo para el participante o que pueda interferir con la interpretación de los datos del estudio.
23. En Francia se excluyen los siguientes participantes: poblaciones vulnerables conforme al artículo L.1121-6 del Código de Salud Pública francés y adultos bajo protección jurídica o que no puedan expresar su consentimiento conforme al artículo L.1121-8 del Código de Salud Pública francés.

E.5 End points

E.5.1

Primary end point(s)

Part 1: Safety and tolerability through assessments of frequency and severity of AEs; changes in clinical safety assessments; changes in clinical laboratory parameters.
Part 2: SRR at Week 24, where SRR is defined as the proportion of participants who have a reduction in spleen volume (by imaging) of at least 35% when compared with baseline

Parte 1: Seguridad y tolerabilidad mediante evaluaciones de frecuencia y gravedad de los AA; cambios en las evaluaciones de la seguridad clínica; cambios en los parámetros clínicos analíticos.
Parte 2: TRE en la semana 24, que se define como la proporción de participantes que presentan una reducción del volumen del bazo (por la imagen) de al menos el 35 % en comparación con la visita inicial.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Semana 24

E.5.2

Secondary end point(s)

Safety and tolerability through assessments of frequency and severity of AEs; changes in clinical safety assessments; changes in clinical laboratory parameters.
TSS response rate at Week 24, where TSS response is defined as the proportion of participants who achieve at least 50% reduction in TSS over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before initiation of itacitinib IR (baseline).
The mean change (from Day 1 vs Week 12 and Week 24) in the 5 multi-item functional scale scores and the multi-item global health status scale score (EORTC QLQ-C30).

Seguridad y tolerabilidad mediante evaluaciones de frecuencia y gravedad de los AA; cambios en las evaluaciones de la seguridad clínica; cambios en los parámetros clínicos analíticos.
Tasa de respuesta de TSS en la semana 24, que se define como la proporción de participantes que logran una reducción de al menos el 50 % en la TSS durante los 28 días inmediatamente anteriores al final de la semana 24 en comparación con los 7 días inmediatamente anteriores al inicio de la liberación inmediata de itacitinib (visita inicial).
El cambio medio (desde el día 1 en comparación con la semana 12 y la semana 24) obtenido en las 5 puntuaciones de la escala funcional de varios elementos y la puntuación en el cuestionario fundamental de 30 elementos sobre la calidad de vida de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC QLQ-C30).

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 24

Semana 24

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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

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

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.8.3

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

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

United States

Austria

Belgium

France

Germany

Italy

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

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)

Patients will remain on treatment as long as they are receiving clinical benefit and have not met any criteria for study w/d, until Week 48, at which time they will be eligible for enrollment into an itacitinib rollover study. (Separate protocol.)

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

2021-04-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-06

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

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