Clinical Trials Register

Summary
EudraCT Number:	2015-000665-30
Sponsor's Protocol Code Number:	CHS-0214-05
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-06-01
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

2015-000665-30

A.3

Full title of the trial

An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05)

Estudio de extensión abierto para evaluar la seguridad a largo plazo y la durabilidad de la respuesta de CHS-0214 (CHS-0214-05, OLSES)

A.3.1

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

Coherus Open-Label Safety Extension Study

Estudio de extension abierto sobre seguridad de Coherus

A.3.2

Name or abbreviated title of the trial where available

OLSES

A.4.1

Sponsor's protocol code number

CHS-0214-05

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	Coherus BioSciences, 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	Coherus Biosciences Inc.
B.4.2	Country	United States
B.4.1	Name of organisation providing support	Daiichi Sankyo Company Ltd.
B.4.2	Country	Japan
B.4.1	Name of organisation providing support	Baxter (Baxter International Inc., Baxter Healthcare Corporation, Baxter Healthcare SA)
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	Medpace UK
B.5.2	Functional name of contact point	Director of Regulatory Submissions
B.5.3	Address:
B.5.3.1	Street Address	1st Floor, 26-28 Hammersmith Grove
B.5.3.2	Town/ city	London
B.5.3.3	Post code	W6 7HA
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00447825587853
B.5.5	Fax number	0044208741 6496
B.5.6	E-mail	b.mcdougall@medpace.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.3.2	Product code	CHS-0214
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Etanercept
D.3.9.1	CAS number	185243-69-0
D.3.9.2	Current sponsor code	CHS-0214
D.3.9.3	Other descriptive name	BGX-0214
D.3.9.4	EV Substance Code	SUB166284
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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

Rheumatoid arthritis
Chronic Plaque Psoriasis

Artritis reumatoide
Psoriasis crónica en placas

E.1.1.1

Medical condition in easily understood language

Rheumatoid arthritis
Chronic Plaque Psoriasis

Artritis reumatoide
Psoriasis crónica en placas

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10042952
E.1.2	Term	Systemic rheumatoid arthritis
E.1.2	System Organ Class	100000004859

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10071117
E.1.2	Term	Plaque psoriasis
E.1.2	System Organ Class	100000004858

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 longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS 0214-04, evaluating CHS 0214 in rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.

Evaluar la seguridad a largo plazo y la durabilidad de la respuesta de los pacientes que hayan completado 48 semanas de evaluaciones en los estudios confirmatorios de la seguridad y la eficacia, CHS-0214-02 o CHS-0214-04, que evalúan CHS-0214 en la artritis reumatoide (AR) y la psoriasis en placa, respectivamente.

E.2.2

Secondary objectives of the trial

N/A

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have completed 48 weeks of evaluations in CHS 0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS 0214-04 and, at Week 48, had at least a PASI-50;
2. Women who either:
a) Are of childbearing potential with a negative urine pregnancy test at Week 0 Day 0 (considered to correspond to the Week 48 Visit of the preceding study) who agree to use 1 or more approved methods of birth control (hormonal contraception, intrauterine device, diaphragm plus spermicide, condom plus spermicide, or abstinence from heterosexual intercourse?abstinence from heterosexual intercourse will be acceptable only if it is the preferred and usual lifestyle of the subject regardless of study participation; abstinence should be practiced for the duration of the study (study duration includes the Early Termination (ET)/Follow-up Visit) after taking the last dose of study drug; or
b) Have been postmenopausal for at least 2 years (with amenorrhea for at least 1 year) or have had a hysterectomy, bilateral salpingo oophorectomy, or tubal ligation prior to signing the informed consent; and
3. Able and willing to give written informed consent prior to performance of any study related procedures.

1. Haber completado 48 semanas de evaluaciones en el estudio CHS-0214-02 y, en la semana 48, presentar como mínimo una respuesta ACR20, o haber completado 48 semanas de evaluaciones en el estudio CHS-0214-04 y, en la semana 48, presentar como mínimo una puntuación PASI-50;
2. Mujeres que:
a) Sean fértiles y tengan resultado negativo en una prueba de embarazo en orina el día 0 de la semana 0 (que se considera que se corresponde con la visita de la semana 48 del estudio precedente) que acepten utilizar uno o más métodos anticonceptivos aprobados (anticonceptivo hormonal, dispositivo intrauterino, diafragma más espermicida, preservativo más espermicida o abstinencia de relaciones heterosexuales. La abstinencia de relaciones heterosexuales solo será aceptable si se corresponde con el estilo de vida preferente y habitual de la paciente, con independencia de su participación en el estudio; la abstinencia deberá practicarse mientras dure el estudio (la duración del estudio incluye la visita de finalización prematura [FP]/seguimiento) después de haber recibido la última dosis del fármaco del estudio;
b) sean posmenopáusicas desde hace un mínimo de 2 años (con amenorrea desde hace 1 año como mínimo) o que hayan sido sometidas a histerectomía, salpingooforectomía bilateral o ligadura de trompas antes de la firma del consentimiento informado; y
3. Pacientes que puedan y quieran dar su consentimiento informado por escrito antes de realizarse cualquier procedimiento relacionado con el estudio.

E.4

Principal exclusion criteria

1. Men whose partners may become pregnant (do not agree to use contraception or who are not postmenopausal) or who may breastfeed during the study (Japan only specific exclusion).

1. Varones cuyas parejas puedan quedarse embarazadas (porque no acepten utilizar métodos anticonceptivos o no sean posmenopáusicas) o puedan estar en periodo de lactancia durante el estudio (criterio de exclusión específico para Japón).

E.5 End points

E.5.1

Primary end point(s)

SAFETY: Safety will be assessed by:
? Assessment of treatment-emergent AEs;
? Determination of subject withdrawal information;
? Assessment of injection site reactions;
? Assessment of changes in safety laboratory parameters, including hematology, clinical chemistry, and pregnancy tests;
? Assessment of changes in vital signs, physical examination, and electrocardiogram findings;
? Monitoring for tuberculosis (TB) with regular QuantiFERON®-TB Gold test (every 12 months or more frequently for regions with high incidences of TB or to evaluate signs and symptoms that might be due to TB); and
? Assessment of immunogenicity (anti-CHS 0214 antibodies)

EFFICACY: Durability of response will be measured as follows:
? For subjects with RA, maintenance of an ACR20 response or greater
? For subjects with PsO, maintenance of PASI-50 response or greater

Seguridad:
La seguridad se evaluará 1 y 3 meses después de la inclusión, y cada 3 meses a partir de ese momento, mediante:
? La evaluación de los AA surgidos durante el tratamiento;
? La determinación de la información sobre retiradas de los pacientes;
? La evaluación de las reacciones en el lugar de inyección;
? La evaluación de las variaciones en los parámetros analíticos de seguridad, incluido el hemograma, la bioquímica clínica y las pruebas de embarazo;
? La evaluación de los cambios en las constantes vitales, la exploración física y los datos electrocardiográficos;
? Determinación de la presencia de tuberculosis (TB) mediante la realización periódica de la prueba de detección Quantiferon®-TB Gold (cada 12 meses o con mayor frecuencia en regiones con una incidencia elevada de TB o para evaluar signos y síntomas que podrían deberse a TB); y
? Evaluación de la inmunogenicidad (anticuerpos anti-CHS-0214).

Criterios de valoración de la eficacia:
La durabilidad de la respuesta se medirá en todas las visitas de la siguiente manera:
? En pacientes con AR, mantenimiento de una respuesta ACR20 o superior
? En pacientes con psoriasis en placa, mantenimiento de una puntuación PASI 50 o superior

E.5.1.1

Timepoint(s) of evaluation of this end point

SAFTEY: At 1 month and 3 months following enrollment and every 3 months thereafter
EFFICACY: At each visit

SEGURIDAD: al mes y a los tres meses después del reclutamiento y después cada tres meses

EFICACIA: en cada visita

E.5.2

Secondary end point(s)

Retained Samples:
Serum samples will be collected at each visit and retained for potential analysis of serum concentration of CHS 0214, anti-drug antibodies, or other tests as necessary to evaluate AEs, loss of response, or compliance. Serum samples will not be used to assess population pharmacokinetics (PK), biomarkers, or genetics. Samples will be stored at Medpace Reference Laboratory, LLC (MRL) and may be transferred to Charles River Laboratories or other reference laboratory for analysis at the request of the Sponsor. All retained samples and remnants of samples will be destroyed 2 years after the completion of the study (data base lock).

Conservación de muestras:
Se obtendrán muestras séricas en todas las visitas y se conservarán para el posible análisis de la concentración sérica de CHS-0214, los anticuerpos antifármaco u otras pruebas que puedan ser necesarias para evaluar los AA, la pérdida de respuesta o el cumplimiento terapéutico. Las muestras séricas no se emplearán para evaluar la farmacocinética (FC) poblacional, los biomarcadores o la genética. Las muestras se almacenarán en Medpace Reference Laboratory, LLC (MRL) y se podrán transferir a Charles River Laboratories o a otro laboratorio de referencia para su análisis si lo solicita el promotor. Todas las muestras conservadas y los restos que queden de ellas se destruirán dos años después de completado el estudio (cierre de la base de datos).

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to 2 years after completion of the study (data base lock).

Hasta dos años después de completado el estudio (cierre de la base de datos).

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

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.8.2.4

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

Australia

Canada

France

Germany

Israel

Italy

Japan

South Africa

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

LPLV

Ultima visita del ultimo 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:

380

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

447

F.5

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

None

Ninguno

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

2015-07-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-10-18

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