Clinical Trials Register

Summary
EudraCT Number:	2017-002274-39
Sponsor's Protocol Code Number:	A3921288
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:	2017-12-22
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-002274-39

A.3

Full title of the trial

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

ESTUDIO EN FASE IIIB/IV, MULTICÉNTRICO, DOBLE CIEGO,
ALEATORIZADO Y DE GRUPOS PARALELOS DE TOFACITINIB (CP-690,550) EN SUJETOS CON COLITIS ULCEROSA EN REMISIÓN ESTABLE

A.3.1

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

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

Estudio multicéntrico y de grupos paralelos de tofacitinib en pacientes con colitis ulcerosa en remisión estable

A.4.1

Sponsor's protocol code number

A3921288

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	Pfizer Inc, 235 East 42nd Street, New York, New York 10017
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	Pfizer 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	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	3491 490 99 00
B.5.5	Fax number	001303739 1119
B.5.6	E-mail	clinicaltrials.govcallcenter@pfizer.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	Yes
D.2.1.1.1	Trade name	XELJANZ
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
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	Tofacitinib citrate
D.3.2	Product code	CP-690,550-10
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	tofacitinib
D.3.9.1	CAS number	540737-29-9
D.3.9.2	Current sponsor code	CP-690,550-10
D.3.9.3	Other descriptive name	CP-690,550
D.3.9.4	EV Substance Code	SUB20282
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ulcerative colitis

Colitis ulcerosa

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	20.1
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 evaluate the efficacy and safety of tofacitinib in subjects in stable remission on 10 mg BID who decrease the dose to and remain on 5 mg BID (“fixed 5 mg BID dose group”) compared to subjects remaining on 10 mg BID. Primary comparisons will be based on data from the first 6 months.

Evaluar la eficacia y la seguridad de tofacitinib en pacientes en remisión estable que toman 10 mg dos veces al día y que reducen la dosis a 5 mg dos veces al día y se mantienen con dicha dosis (“grupo con dosis fija de 5 mg dos veces al día”) en comparación con los pacientes que se mantienen con la dosis de 10 mg dos veces al día. Las comparaciones principales se basarán en los datos de los primeros 6 meses.

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy and safety of tofacitinib in subjects in stable remission on 10 mg BID who decrease the dose to 5 mg BID with option for dose escalation for flare (“flexible dosing regimen”) compared to subjects staying on 10 mg BID for 18 months.
• To evaluate the efficacy and safety of the subset of subjects in stable remission on 10 mg BID who have flare after dose decrease to tofacitinib 5 mg BID and are re-treated with 10 mg BID.

•Evaluar la eficacia y la seguridad de tofacitinib en pacientes en remisión estable que toman 10 mg dos veces al día y que reducen la dosis a 5 mg dos veces al día con la opción de aumentar la dosis de forma escalonada en caso de exacerbación (“pauta posológica flexible”) en comparación con los pacientes que siguen tomando 10 mg dos veces al día durante 18 meses.
•Evaluar la eficacia y la seguridad del subgrupo de pacientes en remisión estable que toman 10 mg dos veces al día y que sufren una exacerbación tras reducir la dosis a 5 mg de tofacitinib dos veces al día y vuelven a tratarse con 10 mg dos veces al día.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects currently enrolled in Study A3921139 who were initially assigned to tofacitinib 10 mg BID at baseline of A3921139.
2. Subjects who are in stable remission on tofacitinib 10 mg BID for the 6 month period in Study A3921139 up to and including baseline of Study A3921288, defined as meeting all of the following criteria:
a. A partial Mayo score <=2, with no individual subscore >1 and a rectal bleeding subscore of 0 at each study visit during the 6 month period in Study A3921139 prior to and including baseline of Study A3921288;
b. AND at least one assessment of remission based on Mayo score;
• If an endoscopy was not completed <=6 months prior to baseline of Study A3921288, then an endoscopy performed in study A3921139 with an endoscopic subscore of 0 or 1, will be required prior to randomization into Study A3921288.
• All available assessments based on Mayo score during this period must show remission.
c. AND subjects must not be receiving any corticosteroid therapy for their UC for at least 4-weeks prior to baseline.
3. Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Subjects in Canada who are women of childbearing potential and sexually active must use two contraceptive methods at the same time: one highly effective contraceptive method and one additional effective contraceptive method (see Protocol Section 4.4.4).
4. Female subjects of childbearing potential must have a negative urine pregnancy test prior to randomization.
5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, bowel movement diary calls, and other study procedures.
6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

1.Pacientes incluidos actualmente en el Estudio A3921139 asignados inicialmente al grupo de 10 mg de tofacitinib dos veces al día al inicio de A3921139.
2.Pacientes en remisión estable que reciben 10 mg de tofacitinib dos veces al día durante el periodo de 6 meses del Estudio A3921139 hasta el inicio inclusive del Estudio A3921288, definidos como aquellos que reúnen todos los criterios siguientes:
a.Una puntuación Mayo parcial <=2, sin ninguna subpuntuación individual >1 y con una subpuntuación de hemorragia rectal de 0 en cada visita del estudio durante el periodo de 6 meses del Estudio A3921139 antes del inicio del Estudio A3921288 y durante dicho Estudio;
b.Y al menos una evaluación de la remisión basada en la puntuación Mayo;
•Si no se ha realizado una endoscopia <=6 meses antes del inicio del Estudio A3921288, será necesario realizar una en el Estudio A3921139 que tenga una subpuntuación endoscópica de 0 o de 1 antes de ser aleatorizado para el Estudio A3921288.
•Todas las evaluaciones disponibles basadas en la puntuación Mayo durante este periodo deben mostrar remisión.
c.Y los pacientes no deben recibir ningún tratamiento con corticoesteroides para la CU durante al menos 4 semanas antes del inicio.
3.Pacientes que sean mujeres con capacidad para concebir deben acceder a utilizar un método anticonceptivo de eficacia elevada durante todo el estudio y durante al menos los 28 días siguientes a la administración de la última dosis del tratamiento asignado. Pacientes en Canadá que sean mujeres con capacidad para concebir y sexualmente activas deben usar dos métodos anticonceptivos al mismo tiempo: uno de eficacia elevada y otro método adicional eficaz (véase la Sección 4.4.4 del Protocolo).
4.Pacientes que sean mujeres con capacidad para concebir deben dar negativo en una prueba de embarazo en orina antes de la aleatorización.
5.Pacientes que estén dispuestos y sean capaces de cumplir con las visitas programadas, el plan de tratamiento, los análisis de laboratorio, las llamadas del diario de deposiciones y otros procedimientos del estudio.
6.Constancia de un formulario de consentimiento informado firmado y fechado personalmente que indique que se ha informado al paciente (o a un representante legal) de todos los aspectos pertinentes del estudio.

E.4

Principal exclusion criteria

1. Subjects who were initially assigned to tofacitinib 5 mg BID at baseline of Study A3921139.
2. Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.
3. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn’s disease.
4. Subjects who in the opinion of the investigator, are likely to require surgery for UC during the study period.
5. Subjects who are expected to receive any prohibited medications, including medications that are either moderate to potent CYP3A inducers or inhibitors, during the study period as specified in the protocol (see Protocol Appendix 3).
6. Subjects who are expected to receive live or attenuated virus vaccination during study period and for 6 weeks after last dose of investigational product.
7. Women who are pregnant or breastfeeding, or planning to become pregnant during the study period.
8. Subjects with evidence of colonic malignancy or any dysplasia (eg, “flat dysplasia”; polyp) identified on endoscopic exam during Study A3921139. Subjects with completely resected adenomatous polyp(s) outside of (proximal to) the extent of colitis may be eligible upon consultation with the sponsor. Note, pathology report must be reviewed prior to subject enrolment.
9. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
10. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
11. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
12. Participation in other studies involving investigational drug(s) during study participation.

1. Pacientes asignados inicialmente al grupo de 5 mg de tofacitinib dos veces al día al inicio del Estudio A3921139.
2. Pacientes asignados inicialmente al grupo de 10 mg de tofacitinib dos veces al día al inicio del Estudio A3921139 y cuya dosis de tofacitinib se haya reducido a 5 mg dos veces al día por motivos de seguridad o de eficacia.
3. Presencia de colitis indeterminada, colitis microscópica, colitis isquémica, colitis infecciosa o hallazgos clínicos que indiquen enfermedad de Crohn.
4. Pacientes que, en opinión del investigador, sea probable que necesiten cirugía para la CU durante el periodo del estudio.
5. Pacientes que se prevea que van a recibir algún medicamento prohibido, como medicamentos que sean inductores o inhibidores moderados o potentes del CYP3A durante el periodo del estudio según lo especificado en el protocolo (véase el Apéndice 3 del Protocolo).
6. Pacientes que se prevea que van a recibir alguna vacunación con virus vivos o atenuados durante el periodo del estudio y durante las 6 semanas siguientes a la administración de la última dosis del producto en investigación.
7. Mujeres embarazadas o en periodo de lactancia, o que tengan previsto quedarse embarazadas durante el periodo del estudio.
8. Pacientes con indicios de neoplasia maligna o de alguna displasia colónicas (p. ej., “displasia plana”, pólipo) detectados en la exploración endoscópica durante el Estudio A3921139. Los pacientes con uno o varios pólipos adenomatosos resecados íntegramente fuera de (proximales a) la sección con colitis pueden ser aptos previa consulta con el promotor. Cabe señalar que es preciso revisar el informe anatomopatológico antes de la inclusión del paciente.
9. Otras enfermedades o alteraciones psiquiátricas, agudas o crónicas, incluidos los pensamientos o comportamientos suicidas recientes (en el último año) o activos, o anomalías de laboratorio que puedan aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación, o que puedan interferir con la interpretación de los resultados del estudio y, a juicio del investigador, hagan que el paciente no sea apto para incorporarse al estudio.
10. Empleados del centro de investigación directamente implicados en la realización del ensayo, así como sus familiares, empleados del centro supervisados de alguna otra manera por el investigador o pacientes que sean empleados de Pfizer, incluidos sus familiares, que estén directamente implicados en la realización del estudio.
11. Pacientes que, en opinión del investigador o de Pfizer, no vayan a cooperar o no puedan cumplir con los procedimientos del estudio.
12. Participación en otros estudios con fármaco(s) en investigación durante la participación en el estudio.

E.5 End points

E.5.1

Primary end point(s)

Remission based on modified Mayo score at Month 6.

Remisión según la puntuación Mayo modificada en el Mes 6.

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary analysis will be performed at Month 6 based on the FAS for the estimation of
treatment difference between two dose groups: Tofacitinib 10 mg BID and Tofacitinib 5 mg BID.
The stratified estimation of the treatment difference between tofacitinib 10 mg BID and 5 mg BID in the proportion of subjects with remission at Month 6 will be presented along with its 95% confidence interval (CI). The Cochran-Mantel-Haenszel (CMH) weight method will be used for the stratified estimation of the treatment difference. The stratified CI will be constructed using the NewCombe method. Subjects with dose escalation prior to Month 6 or with missing values at Month 6 will be treated as non-responders at Month 6.

El análisis principal se realizará en el Mes 6 basándose en el CAC para el cálculo de la diferencia entre tratamientos entre dos grupos de dosis: 10 mg de tofacitinib 2 veces/día y 5 mg de tofacitinib 2 veces/día.
El cálculo estratificado de la diferencia entre tratamientos entre 10 mg y 5 mg de tofacitinib dos veces/día en la proporción de pacientes en remisión en el Mes 6 se presentará junto con su intervalo de confianza (IC) del 95%. Se utilizará el método de ponderación de Cochran-Mantel-Haenszel (CMH) para el cálculo estratificado de la diferencia entre tratamientos. El IC estratificado se construirá utilizando el método NewCombe. Los pacientes con aumento escalonado de la dosis antes del Mes 6 o con valores ausentes en dicho mes se tratarán como pacientes sin respuesta en el Mes 6.

E.5.2

Secondary end point(s)

Secondary Efficacy Endpoints:
• Time to loss of remission based on modified Mayo score.
• Remission based on the following: modified Mayo score, modified partial Mayo score, total Mayo score, and partial Mayo score.
• Change from baseline (of Study A3921288) in the following: modified Mayo score, modified partial Mayo score, total Mayo score, and partial Mayo score.
• Mucosal healing.
• Clinical response based on Mayo score.
• Change from baseline in fecal calprotectin and hs-CRP levels.
For additional safety endpoints please refer to the study protocol.

Criterios de Valoración Secundarios de la Eficacia:
• Tiempo hasta la pérdida de remisión según la puntuación Mayo modificada.
• Remisión según lo siguiente: puntuación Mayo modificada, puntuación Mayo parcial modificada, puntuación Mayo total y puntuación Mayo parcial.
• Cambio con respecto al inicio (del Estudio A3921288) en lo siguiente: puntuación Mayo modificada, puntuación Mayo parcial modificada, puntuación Mayo total y puntuación Mayo parcial.
• Curación de la mucosa.
• Respuesta clínica según la puntuación Mayo.
• Cambio con respecto al inicio en los niveles de calprotectina fecal y de PCR-as.
Por favor, refiéranse al protocolo del estudio para criterios de valoración de seguridad adicionales.

E.5.2.1

Timepoint(s) of evaluation of this end point

For efficacy endpoints based on Mayo score, the change from baseline will be analyzed using an analysis of covariance model with treatment group, the endoscopic subscore at baseline (0 versus 1) as factors and baseline score as a covariate. For other endpoints, the change from baseline will be analyzed using linear mixed-effects model with baseline value, treatment group, the endoscopic subscore at baseline (0 versus 1), visit, and treatment group by visit interaction all as fixed effects, and an unstructured covariance matrix for within-subject measurements over visits. The adjusted estimations and associated 95% CI for the overall difference between the two groups will be computed.

Para los criterios de valoración de la eficacia basados en la puntuación Mayo, el cambio respecto al basal se analizará con un modelo de análisis de la covarianza con el grupo de tratamiento y la subpuntuación endoscópica del basal (0 vs 1) como factores y la puntuación basal como covariable. En otros criterios de valoración, el cambio respecto al basal se analizará con modelo lineal de efectos mixtos con el valor basal, el grupo de tratamiento, la subpuntuación endoscópica del basal (0 vs 1), la visita y la interacción entre el grupo de tratamiento y la visita como efectos fijos, y una matriz de covarianza sin estructurar para las mediciones intrapaciente a lo largo de las visitas. Se computarán los cálculos ajustados y el IC del 95% asociado de la diferencia general entre ambos grupos.

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

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

Yes

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

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

Austria

Belgium

Canada

Czech Republic

France

Germany

Hungary

Italy

Japan

Korea, Republic of

Netherlands

New Zealand

Poland

Russian Federation

Serbia

Slovakia

South Africa

Spain

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 trial (EOT) in a Member State of EU is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application and ethics application in the Member State.
EOT in all other participating countries is defined as Last Subject Last Visit which is the last follow up visit for the last subject.

El final del ensayo (FdE) en un Estado Miembro de la UE se define como el momento en el que se considera que se ha reclutado a un número suficiente de pacientes y estos han finalizado el estudio según lo declarado en la solicitud reglamentaria y en la solicitud presentada ante el comité de ética del Estado Miembro. El FdE en el resto de los países participantes se define como la Última Visita del Último Paciente, que es la última visita de seguimiento del último paciente.

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:

127

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

130

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)

When the trial completes the patients will revert to the local standard of care for Ulcerative Colitis.

Cuando concluya el ensayo, los pacientes volverán al tratamiento estándar local para la Colitis Ulcerosa.

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

2017-12-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-04

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-03-18

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