Clinical Trials Register

Summary
EudraCT Number:	2012-004389-16
Sponsor's Protocol Code Number:	RDEA594-306
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:	2013-06-13
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

2012-004389-16

A.3

Full title of the trial

A Long-Term Extension Study of Lesinurad in Combination with Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol

Estudio de extensión a largo plazo de lesinurad en combinación con alopurinol para los pacientes que finalicen un estudio de eficacia y seguridad de lesinurad y alopurinol

A.3.1

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

Lesinurad and Allopurinol Combination Extension Study in Gout

Combinación de Lesinurad y Allopurinol en un estudio de Extesión de gota

A.4.1

Sponsor's protocol code number

RDEA594-306

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	Ardea 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	Ardea Biosceince, 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	Ardea Biosciences, Inc.
B.5.2	Functional name of contact point	Clinical Program Manager
B.5.3	Address:
B.5.3.1	Street Address	4939 Directors Place
B.5.3.2	Town/ city	San Diego
B.5.3.3	Post code	92121
B.5.3.4	Country	United States
B.5.4	Telephone number	18586526721
B.5.5	Fax number	18586250745
B.5.6	E-mail	msuster@ardeabio.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	lesinurad
D.3.2	Product code	RDEA594
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	lesinurad
D.3.9.1	CAS number	878672-00-5
D.3.9.2	Current sponsor code	RDEA594
D.3.9.4	EV Substance Code	SUB30439
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.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	lesinurad
D.3.2	Product code	RDEA594
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	lesinurad
D.3.9.1	CAS number	878672-00-5
D.3.9.2	Current sponsor code	RDEA594
D.3.9.4	EV Substance Code	SUB30439
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Gout

Gota

E.1.1.1

Medical condition in easily understood language

Gout

Gota

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10018627
E.1.2	Term	Gout
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

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 assess the long-term efficacy and safety of lesinurad in combination with allopurinol

Evaluar la eficacia y la seguridad a largo plazo de lesinurad en combinación con alopurinol

E.2.2

Secondary objectives of the trial

To determine the effect of lesinurad when used in combination with allopurinol on Health Related Quality of Life and physical function.

Determinar el efecto de lesinurad sobre la calidad de vida relacionada con la salud y la función física cuando se utiliza en combinación con alopurinol

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
-Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
-Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.

-El paciente tiene capacidad de entender los procedimientos del estudio así como los riesgos implicados y desea otorgar un consentimiento informado por escrito antes de que se lleve a cabo la primera actividad relacionada con el estudio.
-El paciente ha completado el periodo de tratamiento doble ciego del estudio RDEA594-301 o del estudio RDEA594-302 y estaba recibiendo activamente y tolerando la medicación del estudio (lesinurad o placebo) y alopurinol en la visita del mes 12.
-El paciente desea adherirse al calendario de visitas/del protocolo.
-El paciente es hombre o mujer; las mujeres con capacidad de quedar embarazadas deben aceptar usar un método anticonceptivo no hormonal efectivo durante el estudio y durante al menos 14 días después de la última dosis de la medicación del estudio.

E.4

Principal exclusion criteria

-Subject has any medical or psychological condition which in the opinion of the Investigator and /or the Medical Monitor might create undue risks to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.

-El paciente presenta cualquier afección médica o psicológica que, a juicio del investigador y/o del monitor médico, podría provocar un riesgo innecesario para el paciente o interferir con la capacidad del paciente para cumplir con los requisitos del protocolo o para completar el estudio.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects whose sUA level is <6.0mg/dL at each visit

Proporción de pacientes cuyo nivel de AUs sea <6,0 mg/dl en cada visita.

E.5.1.1

Timepoint(s) of evaluation of this end point

Each visit

Cada visita

E.5.2

Secondary end point(s)

Proportion of subjects with ?1 target tophus at Baseline in Study RDEA594-301 or RDEA594-302 who experience complete resolution of at least 1 target tophus at any time up to month 12 of the extension.
Proportion of the subjects whose sUA level is <5.0mg/dL and <4.0mg/dL at each visit
Absolute and percent change from Baseline in sUA levels at each visit
Mean rate of gout flares requiring treatment over time
Proportion of subjects requiring treatment for a gout flare over time

Proporción de pacientes con > o = 1 tofo diana en la visita basal del estudio RDEA594-301 o RDEA594-302 que presenten una resolución completa de, como mínimo, 1 tofo diana en cualquier momento hasta el mes 12 de la extensión.
Proporción de pacientes cuyo nivel de AUs sea <5,0 mg/dl y <4,0 mg/dl en cada visita.
Cambio absoluto y porcentual en los niveles de AUs de cada visita respecto a la visita basal.
Tasa media de crisis de gota que requieren tratamiento en el transcurso del tiempo.
Proporción de pacientes que requieren tratamiento para una crisis de gota en el transcurso del tiempo.

E.5.2.1

Timepoint(s) of evaluation of this end point

Each visit

Cada visita

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Los pacientes reciben 200 mg o 400 mg de lesinurad

Patients receive either 200 mg lesinurad or 400 mg lesinurad

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

Belgium

Canada

France

Germany

New Zealand

Poland

South Africa

Spain

Switzerland

Ukraine

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

Last subject last visit

Último paciente última visita

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:

1160

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

1200

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)

At study termination, subjects with ongoing AEs/SAEs, including clinically relevant laboratory abnormalities, should be followed up by the Investigator for as long as medically indicated. The Sponsor retains the right to request additional information for any subject with ongoing AEs/SAEs at the end of the study, if judged necessary.

Al final del estudio, los pacientes con AA/AAG en curso, incluidos resultados de laboratorio anormales clínicamente relevantes, deberán ser objeto de seguimiento por parte del investigador durante el tiempo que sea necesario según criterio médico. El promotor conserva el derecho de solicitar información adicional sobre cualquier paciente con AA/AAG en curso al final del estudio, si se considera necesario.

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

2013-06-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-11-17

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