Clinical Trials Register

Summary
EudraCT Number:	2006-005917-36
Sponsor's Protocol Code Number:	CIGE025C2303
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:	2007-06-20
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

2006-005917-36

A.3

Full title of the trial

Estudio abierto, de un único grupo, para evaluar la seguridad e inmunogenicidad de omalizumab líquido administrado por vía subcutánea en una jeringa de seguridad pre-cargada (75 mg o 150 mg) durante un periodo de 6 meses a hombres y mujeres adolescentes y adultos con asma alérgica persistente de moderada a grave.

A.3.2

Name or abbreviated title of the trial where available

not available

A.4.1

Sponsor's protocol code number

CIGE025C2303

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

not available

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Farmacéutica, S.A.
B.1.3.4	Country	Spain
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	omalizumab liquido 75 mg
D.3.2	Product code	IGE025C
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	242138-07-4
D.3.9.2	Current sponsor code	IGE025C
D.3.9.3	Other descriptive name	omalizumab líquido 75 mg
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	75
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	omalizumab líquido 150 mg
D.3.2	Product code	IGE025C
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	242138-07-04
D.3.9.2	Current sponsor code	IGE025C
D.3.9.3	Other descriptive name	omalizumag líquido 150 mg
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	150
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Asma alérgica persistente de moderada a grave

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar el potencial inmunogénico de omalizumab líquido cuando se administra durante un periodo de 6 meses en pacientes no expuestos a omalizumab, con asma alérgica persistente moderada a grave de 12 años de edad o mayores.

E.2.2

Secondary objectives of the trial

Evaluar la seguridad y tolerabilidad de omalizumab líquido cuando se administra durante un periodo de 6 meses en pacientes no expuestos a omalizumab, con asma alérgica persistente moderada a grave de 12 años de edad o mayores.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. pacientes hombres o mujeres que (o cuando proceda cuyos guardianes legales) hayan sido informados de los procedimientos y de las medicaciones del estudio y que hayan otorgado el consentimiento informado por escrito
2. al menos 12 años de edad
3. con un peso ≥ 30 kg y ≤ 150 kg y con una concentración sérica de IgE total ≥ 30 a ≤ 700 UI/ml (consistente con la USPI – tabla de dosificación proporcionada en las Tablas 6-1 y 6-2)
4. antecedentes de asma persistente moderada a grave consistente con las guías NHLBI (ver Apéndice 3)
5. prick test cutáneo positivo (diámetro de pápula  3 mm) a al menos un aeroalergeno perenne (p.e. ácaros del polvo, caspa de gato/perro, cucarachas), documentado en la historia clínica del paciente o realizado en la Visita 1. Alternativamente, se puede realizar un RAST test
6. Síntomas de asma no controlados adecuadamente con corticosteroides inhalados

E.4

Principal exclusion criteria

1. exposición previa a omalizumab
2. exposición previa a otras proteínas humanizadas o monoclonales
3. HAHA conocido a otros anticuerpos monoclonales
4. utilización de otros fármacos en investigación en el momento del reclutamiento, o durante los 30 días previos al reclutamiento o  5 vidas medias del fármaco antes del reclutamiento, lo que sea más largo
5. tratamiento de mantenimiento con corticosteroides sistémicos por otras razones aparte de asma durante las 4 semanas previas a la selección
6. utilización de metotrexato, sales de oro o ciclosporina durante los 3 meses previos a la selección
7. antecedentes de hipersensibilidad a alguno de los fármacos del estudio o a fármacos con estructura química similar
8. hipersensibilidad a alguno de los ingredientes, incluyendo excipientes (Hidrocloruro de arginina, histidina, Polisorbato 20) de la medicación del estudio o fármacos relacionados a omalizumab (p.e. anticuerpos monoclonales, gamma globulina policlonal)
9. anomalías clínicamente significativas de las analíticas de laboratorio (no asociado con asma moderada a grave) en la Visita 1
10. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta la finalización de la gestación, confirmado mediante una prueba de laboratorio de hCG positiva (> 5 mUI/ml)
11. Mujer en edad fértil (WOCBP), definida como toda mujer psicológicamente capaz de quedarse embarazada, incluyendo mujeres cuya carrera, estilo de vida, u orientación sexual que imposibilite las relaciones sexuales con una pareja masculina y las mujeres cuyas parejas se hayan esterilizado por vasectomía u otros medios, A MENOS (1) que cumplan la siguiente definición de post-menopausia: 12 meses de amenorrea natural (espontánea) o 6 meses de amenorrea espontánea con concentraciones séricas de FSH > 40 mUI/ml, O (2) que hayan pasado 6 semanas de ooferectomía bilateral post-quirúrgica con o sin histerectomía o histerectomía O (3) que estén utilizando uno o más de los siguientes métodos anticonceptivos aceptables: esterilización quirúrgica (p.e., ligadura bilateral de trompas, vasectomía), anticonceptivos hormonales (implantables, parches, orales), y DIU recubierto de cobre, cualquier combinación doble de condón masculino o femenino con gel espermicida, diafragma, esponja, tapón cervical. La abstinencia periódica (p.e., métodos del calendario, ovulación, sintotermal, post-ovulación) y la marcha atrás no constituyen métodos anticonceptivos aceptables. El anticonceptivo fiable debe mantenerse a lo largo de todas las fases del estudio.
12. considerado potencialmente no fiable o cuando se prevea que puede ser que el paciente no acuda de forma consistente a las visitas del estudio programadas
13. antecedentes de abuso de fármacos o alcohol o utilización actual de drogas ilegales
14. enfermedades médicas significativas aparte de asma como: cualquier alteración infecciosa, hematológica, renal, hepática, endocrina, respiratoria (aparte de asma), gastrointestinal o cardiaca que precise medicaciones diarias; alteraciones neurológicas significativas que precisan medicaciones diarias; cualquier alteración de la coagulación; cualquier retraso mental grave obvio que impida al participante responder preguntas o seguir instrucciones; cualquier enfermedad autoinmune; cualquier deficiencia inmunitaria; o cualquier otra alteración médica grave. Ejemplos: fibrosis quística, bronquiectasia, diabetes Tipo I, hemofilia, enfermedad de Von Willebrands, enfermedad de células falciformes, parálisis cerebral, artritis reumatoide, lupus, soriasis, síndrome de hiperinmunoglobulina E, infecciones parasitarias, Síndrome Wiskott-Aldrich o aspergilosis broncopulmonar alérgica
15. implicado en un litigio relacionado con una enfermedad

E.5 End points

E.5.1

Primary end point(s)

Efectos adversos/efectos adversos graves e inmunogenicidad

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

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

Yes

E.6.13.1

Other scope of the trial description

Inmunogenicidad

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.8.3

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

Information not present in EudraCT

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

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

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	Yes
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	Yes
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	15
F.4.2	For a multinational trial
F.4.2.1	In the EEA	79
F.4.2.2	In the whole clinical trial	100

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

2007-07-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-05-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-09-22

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