Clinical Trials Register

Summary
EudraCT Number:	2016-002765-58
Sponsor's Protocol Code Number:	GS-US-418-3899
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-02-01
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2016-002765-58

A.3

Full title of the trial

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Estudio de extensión a largo plazo para evaluar la seguridad de filgotinib
en pacientes con colitis ulcerosa

A.3.1

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

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

Estudio de extensión a largo plazo para realizar un seguimiento de la seguridad de un nuevo tratamiento en pacientes con colitis ulcerosa

A.4.1

Sponsor's protocol code number

GS-US-418-3899

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	Gilead Sciences, 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	Gilead Sciences, 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	Gilead Sciences International Ltd.
B.5.2	Functional name of contact point	Clinical Trials Mailbox
B.5.3	Address:
B.5.3.1	Street Address	Flowers Building, Granta Park
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	CB21 6GT
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+34913789830
B.5.5	Fax number	+441223897284
B.5.6	E-mail	clinical.trials@gilead.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	Filgotinib
D.3.2	Product code	GS-6034
D.3.4	Pharmaceutical form	Film-coated 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	FILGOTINIB
D.3.9.3	Other descriptive name	Filgotinib
D.3.9.4	EV Substance Code	SUB182273
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Filgotinib
D.3.2	Product code	GS-6034
D.3.4	Pharmaceutical form	Film-coated 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	FILGOTINIB
D.3.9.3	Other descriptive name	Filgotinib
D.3.9.4	EV Substance Code	SUB182273
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	200
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated 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	Film-coated 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

Ulcerative Colitis (UC)

Colitis Ulcerosa (CU)

E.1.1.1

Medical condition in easily understood language

Ulcerative Colitis

Colitis Ulcerosa

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	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10045365
E.1.2	Term	Ulcerative colitis
E.1.2	System Organ Class	100000004856

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 observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in UC

Observar la seguridad a largo plazo de filgotinib en pacientes que hayan completado o que hayan cumplido los criterios de interrupción de un estudio previo de tratamiento con filgotinib para la CU promovido por Gilead

E.2.2

Secondary objectives of the trial

To evaluate the effect of filgotinib on partial Mayo Clinic Score (MCS)

Evaluar el efecto de filgotinib en la puntuación parcial de la Clínica Mayo (MCS)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial
• Must have met all eligibility criteria from a Gilead-sponsored UC parent protocol
• Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC
• Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
• Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
• Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug

• Deben poder comprender y firmar un formulario de consentimiento informado (FCI) por escrito, que debe obtenerse antes de iniciar los procedimientos del estudio relacionados con este ensayo
• Deben haber cumplido todo los criterios de idoneidad de un protocolo original de CU promovido por Gilead
• Deben haber completado todos los procedimientos requeridos o haber cumplido los criterios de interrupción en un estudio previo de tratamiento con filgotinib para la CU promovido por Gilead
• Las pacientes con capacidad de concebir deben tener un resultado negativo en la prueba de embarazo en el Día 1 y deben estar de acuerdo con la realización de pruebas de embarazo mensuales, de forma continua, durante el tratamiento con filgotinib
• Los hombres y las mujeres con capacidad de concebir que mantengan relaciones heterosexuales deben aceptar utilizar los métodos anticonceptivos especificados en el protocolo
• Disposición para evitar recibir vacunas elaboradas con microorganismos vivos o atenuados durante el estudio y durante 12 semanas tras la última dosis del fármaco del estudio

E.4

Principal exclusion criteria

• Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study.
• Known hypersensitivity to the study drug
• Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
• Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 35 days of the last dose of the study drug
• Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug
• Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
• Use of prohibited medications as outlined in the protocol

• Pacientes que sean retirados de un estudio original por motivos distintos al empeoramiento de la enfermedad o a la falta de respuesta o remisión; p. ej., los pacientes que hayan sido retirados por problemas de seguridad o tolerabilidad no son aptos para este estudio.
• Hipersensibilidad conocida al fármaco del estudio
• Cualquier afección médica crónica (entre otras, neumopatía o cardiopatía, alcoholismo o drogadicción) que, en opinión del investigador, haga que el paciente no sea apto para el estudio o impida el cumplimiento del protocolo del mismo
• Mujeres que deseen quedarse embarazadas o tengan previsto someterse a una donación o extracción de óvulos con el objeto de llevar a cabo su fecundación, en el momento actual o en el futuro, durante el transcurso del estudio y durante al menos 35 días después de la última dosis del fármaco del estudio
• Hombres que no estén dispuestos a abstenerse de donar semen durante al menos 90 días después de la última dosis del fármaco del estudio
• Hombres y mujeres con capacidad de procrear que no estén dispuestos a ceñirse a los métodos anticonceptivos especificados en el protocolo
• Uso de medicamentos prohibidos como se indica en el protocolo

E.5 End points

E.5.1

Primary end point(s)

Safety, evaluated through AEs, clinical laboratory tests, and vital signs

Seguridad, evaluada a partir de los AA, pruebas analíticas y constantes
vitales

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 144

semana 144

E.5.2

Secondary end point(s)

Change from baseline in partial MCS

Cambio de la puntuación parcial de MCS respecto al valor inicial

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 144

semana 144

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

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

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Subject to receive open-label or blinded IMP depending on their disease response in the parent study

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

180

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

Argentina

Australia

Austria

Belarus

Belgium

Brazil

Bulgaria

Canada

Croatia

Czech Republic

France

Georgia

Germany

Greece

Hong Kong

Hungary

Iceland

India

Ireland

Israel

Italy

Japan

Korea, Republic of

Malaysia

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Romania

Russian Federation

Serbia

Singapore

Slovakia

South Africa

Spain

Sweden

Switzerland

Taiwan

Ukraine

United Kingdom

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

End of Study is defined as when the last subject has completed 144 weeks of treatment plus 30 days follow-up.

El fin del estudio se ha definido como cuando el ultimo paciente haya completado 144 semanas de tratamiento y 30 dias mas de seguimiento

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:

920

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

380

F.4.2.2

In the whole clinical trial

1000

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)

Post study care is at the discretion of the treating investigator or physician.

Los cuidados a largo plazo seran responsabilidad de sus medicos de atencion primaria

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

2017-01-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-25

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