Clinical Trials Register

Summary
EudraCT Number:	2017-001718-28
Sponsor's Protocol Code Number:	GA39855
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:	2017-11-22
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

2017-001718-28

A.3

Full title of the trial

A PHASE III, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL OF OMALIZUMAB IN PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS

ENSAYO CLÍNICO DE FASE III, ALEATORIZADO, MULTICÉNTRICO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE OMALIZUMAB EN PACIENTES CON RINOSINUSITIS CRÓNICA CON PÓLIPOS NASALES

A.3.1

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

A Phase 3 Clinical Trial of Omalizumab for Chronic Rhinosinusitus with Nasal Polyps

Ensayo fase 3 de Omalizumab en Rinosinusitis crónica con pólipos nasales.

A.4.1

Sponsor's protocol code number

GA39855

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	F. Hoffmann-La Roche Ltd
B.1.3.4	Country	Switzerland
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	F. Hoffmann-La Roche Ltd.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche Ltd.
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+34913257300
B.5.6	E-mail	spain.start_up_unit@roche.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	XOLAIR
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm 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	Omalizumab
D.3.4	Pharmaceutical form	Powder for solution for injection
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	OMALIZUMAB
D.3.9.1	CAS number	242138-07-4
D.3.9.3	Other descriptive name	RO5489789
D.3.9.4	EV Substance Code	SUB12543MIG
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	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	Yes
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	Powder for solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic rhinosinusitis with nasal polyps

Rinosinusitis crónica con pólipos nasales

E.1.1.1

Medical condition in easily understood language

Chronic rhinosinusitis with nasal polyps is a condition in which painless growths called polyps are formed in the nasal passages and the sinuses along with inflammation and swelling

La Rinosinusitis crónica con pólipos nasales es una enfermedad en la que crecimientos indoloros llamados polipos se forman en los pasajes y las fosas nasales junto con inflamacion e hinchazon

E.1.1.2

Therapeutic area

Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10028756
E.1.2	Term	Nasal polyps
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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 evaluate the efficacy of omalizumab compared with placebo

•Evaluar la eficacia de
omalizumab en comparación con
placebo

E.2.2

Secondary objectives of the trial

•To further evaluate the efficacy of omalizumab compared with placebo
•To evaluate the safety of omalizumab compared with placebo
•To evaluate the pharmacokinetics and pharmacodynamics of omalizumab

•Evaluar la eficacia de
omalizumab en comparación con
placebo
•Evaluar la seguridad de
omalizumab en comparación con
placebo
•Evaluar la farmacocinética y
farmacodinámica de omalizumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Age 18-75 years, inclusive, at time of signing Informed Consent Form
-Ability to comply with the study protocol, in the investigator's judgment
-Nasal polyp score (NPS) >= 5, with a unilateral score of >= 2 for each nostril, at screening (Day -35), and on Day -7
-Sino-Nasal Outcome Test-22 (SNOT-22) score >=20 at screening (Day -35) and at randomization (Day 1)
-Treatment with at least nasal mometasone 200 micro gram per day, or equivalent daily dosing of nasal corticosteroid (CS), for at least 4 weeks before screening (Day -35)
-Treatment with nasal mometasone 200 micro gram twice a day (BID) (or QD if intolerant to twice daily) during the run-in period with an adherence rate of at least 70%
- Presence of nasal blockage/congestion with NCS >=2 (1 week recall) at Day -35 and an average of the daily NCS score over the 7 days prior to randomization of NCS >1 with at least one of the following symptoms prior to screening: nasal discharge (anterior/posterior nasal drip) and/or reduction or loss of smell
- Eligibility per the study drugdosing table (serum IgE level >= 30 to =<1500 IU/mL and body weight >= 30 to =< 150 kg) and ability to be dosed per the dosing table
- Willingness to maintain all background medications stable for the duration of the treatment and follow-up periods
- Willingness and ability to use electronic device to enter study-related information in electronic devices (electronic diary [eDiary]/electronic tablet [eTablet])
- Demonstration of at least 70% adherence to eDiary daily symptom assessment during run in period, with fully completed entries on at least 4 days in the week prior to randomization
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug

-Edad de 18-75 años, ambos inclusive, en el momento de firmar el documento de consentimiento
informado.
-Capacidad de cumplir el protocolo del estudio, en opinión del investigador.
-Puntuación NPS >= 5, con una puntuación unilateral >= 2 en cada ventana nasal, en el momento de
selección (día -35) y el día -7
-Puntuación SNOT-22 >= 20 en los momentos de selección (día -35) y aleatorización (día 1).
-Tratamiento con mometasona nasal en una dosis mínima de 200 μg al día, o dosis diaria equivalente de otro corticoide nasal, durante al menos cuatro semanas antes de la selección
(día -35).
-Tratamiento con mometasona nasal 200 μg dos veces al día (o una vez al día en caso de intolerancia a la administración dos veces al día) durante el período de preinclusión con una
adherencia mínima del 70%.
-Presencia de obstrucción/congestión nasal con una puntuación NCS >= 2 (recuerdo de una
semana) el día -35 y un promedio semanal en el momento de aleatorización de NCS>= 1 con
al menos uno de los siguientes síntomas antes de la selección: Secreción nasal (goteo nasal
anterior/posterior) o reducción o pérdida del olfato.
E-legibilidad conforme a la tabla de posología y administración del fármaco del estudio
(concentración sérica de IgE >= 30 y  =<1500 UI/ml y peso corporal >= 30 y =<150 kg) y capacidad
de ser tratado conforme a dicha tabla.
-Disposición a mantener estables todos los medicamentos de base durante los períodos de tratamiento y seguimiento.
-Disposición a utilizar un dispositivo electrónico para introducir en él (diario electrónico o tableta
electrónica) la información relacionada con el estudio y capacidad para ello.
-Demostración de una adherencia mínima del 70% a la evaluación de síntomas diaria mediante el
diario electrónico durante el período de preinclusión, con entradas totalmente completadas
durante al menos cuatro días de la semana previa a la aleatorización.
-Mujeres en edad fértil: compromiso de practicar abstinencia sexual (ausencia de relaciones
heterosexuales) o de utilizar métodos anticonceptivos aceptables durante el período de tratamiento y hasta 60 días después de la última dosis del fármaco del estudio.

E.4

Principal exclusion criteria

-Known history of anaphylaxis/hypersensitivity to omalizumab
-Treatment with investigational drugs within 12 weeks or 5 half lives (whichever is longer) prior to screening (Day -35)
-Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab) for 6 months prior to screening (Day -35)
-Current treatment with leukotriene antagonists/modifiers, unless patient has been on stable dosing of such medication for at least 1 month prior to screening (Day -35)
-Treatment with non-steroid immunosuppressants within 2 months or 5 half-lives, whichever is longer, prior to screening (Day -35)
-Treatment with systemic corticosteroids, except when used as treatment for nasal polyposis, within 2 months prior to screening (Day -35)
-Usage of systemic CS during the run-in period. Patients requiring systemic CS during run-in may be rescreened after completing systemic CS.
-Treatment with intranasal CS drops or CSadministering devices (e.g., OptiNose device or stents) within 1 month prior to screening (Day -35) or during the run-in period
-History of nasal surgery (including polypectomy) within 6 months prior to screening
-History of sinus or nasal surgery modifying the structure of the nose such that assessment of NPS is not possible
-Uncontrolled epistaxis requiring surgical or procedural intervention, including nasal packing, within 2 months prior to screening
-Known or suspected diagnosis of cystic fibrosis, primary ciliary dyskinesia (e.g., Kartagener syndrome) or other dyskinetic ciliary syndromes, hypogammaglobulinemia or other immune deficiency syndrome, chronic granulomatous disease and granulomatous vasculitis, granulomatosis with polyangiitis (e.g., Wegener’s Granulomatosis), or eosinophilic granulomatous with polyangiitis (EGPA) (e.g., Churg-Strauss syndrome)
-Presence of antrochoanal polyps
-Concomitant conditions that interfere with evaluation of primary endpoint:
•Nasal septal deviation occluding one or both nostrils
•Ongoing rhinitis medicamentosa
•Acute sinusitis, nasal infection, or upper respiratory infection during the run-in period
•Known or suspected invasive or expansive fungal rhinosinusitis
-Known HIV infection at screening
-Known acute and chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening
- History of myocardial infarction, unstable angina, cerebrovascular
accident, or transient ischemic attack or a known history of a
hypercoagulable disorder
-Active tuberculosis requiring treatment within 12 months prior to screening (Day -35)
-Initiation of or change in allergen immunotherapy within 3 months prior to screening (Day -35) or during the run-in period
-Initiation of or change in aspirin desensitization within 4 months prior to screening (Day -35) or during the run-in period
-Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab
-Current malignancy or history of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been treated or excised and is considered resolved
-Any serious medical condition (including but not limited to significant arrhythmia, uncontrolled hypertension, significant pulmonary disease other than asthma) or abnormality in clinical laboratory tests that precludes the patient’s safe participation in and completion of the study
-History of alcohol, drug, or chemical abuse within 6 months of screening

-Antecedentes de anafilaxia o hipersensibilidad a omalizumab.
-Tratamiento con medicamentos en investigación en las 12 semanas, o el equivalente a
5 semividas (lo que suponga más tiempo), previas a la selección (día -35).
-Tratamiento con anticuerpos monoclonales (por ejemplo, omalizumab o mepolizumab) en los
seis meses previos a la selección (día -35).
-Tratamiento presente con antagonistas o modificadores de leucotrienos, a menos que el paciente
haya recibido una dosis estable de dicha medicación durante al menos un mes antes de la selección (día -35).
-Tratamiento con inmunodepresores no esteroideos en los dos meses, o el equivalente a
5 semividas (lo que suponga más tiempo), previos a la selección (día -35).
-Tratamiento con corticoides sistémicos, excepto cuando se empleen como tratamiento de la
poliposis nasal, en los dos meses previos a la selección (día -35).
-Uso de corticoides sistémicos durante el período de preinclusión. En los pacientes que precisen
corticoides sistémicos durante la preinclusión podrá repetirse el proceso de selección una vez
que completen el ciclo de corticoides sistémicos.
-Tratamiento con gotas intranasales de corticoides o dispositivos de administración de corticoides
(por ejemplo, dispositivo OptiNose o endoprótesis) en el mes previo a la selección (día -35)
o durante el período de preinclusión.
-Antecedentes de cirugía nasal (incluida polipectomía) en los seis meses previos a la selección.
-Antecedentes de cirugía sinusal o nasal con modificación de la estructura de la nariz de tal modo que imposibilite la evaluación de la puntuación NPS
-Epistaxis incontrolada con necesidad de intervención quirúrgica u otro procedimiento, como
taponamiento nasal, en los dos meses previos a la selección.
-Diagnóstico confirmado o presunto de fibrosis quística, discinesia ciliar primaria (por
ejemplo, síndrome de Kartagener) u otros síndromes ciliares discinéticos,
hipogammaglobulinemia u otra inmunodeficiencia, enfermedad granulomatosa crónica y
vasculitis granulomatosa, granulomatosis con polivasculitis (por ejemplo, granulomatosis de
Wegener) o granulomatosis eosinófila con polivasculitis (por ejemplo, síndrome de Churg-
Strauss).
-Presencia de pólipos antrocoanales.
-Enfermedades concomitantes que dificulten la evaluación del criterio de valoración principal:
•Desviación del tabique nasal que ocluya una o ambas ventanas nasales.
•Rinitis medicamentosa activa.
•Sinusitis, infección nasal o infección de las vías respiratorias superiores durante el período de preinclusión
•Rinosinusitis micótica invasiva o expansiva confirmada o presunta.
-Infección por el VIH conocida en el momento de selección.
-Infecciones agudas y crónicas conocidas por los virus de la hepatitis C (VHC) y B (VHB) en el momento de selección.
-Antecedentes de infarto de miocardio, angina inestable, accidente cerebrovascular o accidente isquémico transitorio, o antecedentes documentados de un trastorno de hipercoagulabilidad.
-Tuberculosis activa con necesidad de tratamiento en los 12 meses previos a la selección (día -35)
-Inicio o modificación de una inmunoterapia con alérgenos en los tres meses previos a la
selección (día -35) o durante el período de preinclusión.
-Inicio o modificación de una desensibilización al ácido acetilsalicílico en los cuatro meses previos
a la selección (día -35) o durante el período de preinclusión.
-Mujer embarazada, en período de lactancia o que pretende quedarse embarazada durante el
estudio o en los 60 días siguientes a la última dosis de omalizumab.
-Neoplasia maligna activa o antecedentes de neoplasia maligna en los cinco años previos a la
selección, excepto carcinoma in situ de cuello uterino debidamente tratado o carcinoma de piel distinto del melanoma que ha sido tratado o extirpado y se considera resuelto.
-Cualquier enfermedad grave (entre otras, arritmia importante, hipertensión no controlada, neumopatía importante distinta del asma) o anomalía en las pruebas analíticas que descarte
la participación segura del paciente en el estudio y su finalización.
-Antecedentes de alcoholismo u otras toxicomanías en los seis meses previos a la selección.

E.5 End points

E.5.1

Primary end point(s)

1.Change from baseline at Week 24 in average daily NCS
2.Change from baseline at Week 24 in nasal polyps score NPS

1. Variación de la NCS diaria
promedio entre el momento basal y la semana 24
2. Variación de la puntuación de pólipos nasales NPS entre el
momento basal y la semana 24

E.5.1.1

Timepoint(s) of evaluation of this end point

1-2.Baseline and Week 24

1-2. En basal y semana 24

E.5.2

Secondary end point(s)

1.Change from baseline at Week 24 in the average daily total nasal symptom score (TNSS)
2.Change from baseline at Week 24 in the average daily sense of smell score
3.Change from baseline at Week 24 in the average daily posterior rhinorrhea score
4.Change from baseline at Week 24 in the average daily anterior rhinorrhea score
5.Change from baseline at Week 24 in patient reported health-related quality of life (HRQoL) as assessed by the total SNOT-22
6.Change from baseline at Week 24 in sense of smell, as assessed by the University of Pennsylvania Smell Identification Test (UPSIT)
7.Change from baseline at Week 24 in Asthma Quality of Life Questionnaire (AQLQ) of >= 0.5 (in patients with comorbid asthma only)
8.Change from baseline at Week 16 in the average daily NCS
9.Change from baseline at Week 16 in NPS
10.Reduction in the need for surgery by Week 24, as defined by an NPS of <= 4 (unilateral score of <= 2 on each side) and improvement in SNOT-22 score of >= 8.9
11.Requirement of rescue treatment (systemic CS for >= 3 consecutive days) or having had surgery for nasal polyps through Week 24
12.Requirement of rescue treatment (systemic CS for >=3 consecutive days) through Week 24
13.Having had surgery for nasal polyps through Week 24
14.Incidence of adverse events
15.Incidence of serious adverse events
16.Incidence of adverse events leading to omalizumab/placebo discontinuation
17.Clinically significant change in laboratory values
18.Serum concentration of omalizumab at specified timepoints
19.Serum concentration of total and free IgE at specified timepoints

1. Variación de la puntuación total de síntomas nasales (TNSS)
diaria promedio entre el momento basal y la semana 24
2. Variación de la puntuación de sentido del olfato diaria promedio entre el momento basal y la semana 24
3. Variación de la puntuación de rinorrea posterior diaria
promedio entre el momento basal y la semana 24
4. Variación de la puntuación de rinorrea anterior diaria
promedio entre el momento basal y la semana 24
5. Variación de la calidad de vida relacionada con la salud
comunicada por los pacientes, evaluada mediante la puntuación SNOT-22 total, entre el momento basal y la semana 24
6. Variación del sentido del olfato, evaluado mediante la prueba
UPSIT, entre el momento basal y la semana 24
7. Variación de la puntuación AQLQ  >= 0,5 (únicamente en
los pacientes con asma coexistente) entre el momento basal
y la semana 24
8. Variación de la puntuación NCS diaria promedio entre el momento basal y la semana 16
9. Variación de la puntuación NPS entre el momento basal y la semana 16
10. Reducción de la necesidad de cirugía en la semana 24, definida como una puntuación NPS <=4 ( puntuación
unilateral <=2 en cada lado) y mejoría de la puntuación SNOT-22 >= 8,9
11. Necesidad de tratamiento de rescate (corticoides sistémicos
durante >= 3 días consecutivos) o práctica de cirugía por pólipos nasales hasta la semana 24
12. Necesidad de tratamiento de rescate (corticoides sistémicos durante >= 3 días consecutivos) hasta la semana 24
13. Práctica de cirugía por pólipos nasales hasta la semana 24
14. Incidencia de acontecimientos adversos
15. Incidencia de acontecimientos adversos graves
16. Incidencia de acontecimientos adversos que motiven la
suspensión de omalizumab/placebo
17. Variación clínicamente significativa de valores analíticos
18. Concentración sérica de omalizumab en momentos
específicos
19. Concentraciones séricas de IgE total y libre en momentos específicos

E.5.2.1

Timepoint(s) of evaluation of this end point

1-7.Baseline and Week 24
8-9.Baseline and Week 16
10-13.Up to Week 24
14-17.Up to Week 28
18. Day 1,Week 16, Week 24, Week 28
19.Screening (Day -35), Day 1, Week 16, Week 24, Week 28

1-7. Basal y semana 24
8-9. Basal y semana 16
10-13. Hasta la semana 24
14-17. Hasta la semana 28
18. Dia 1, Semana 16, Semana 24, Semana 28
19. Screening (dia -35), Dia 1, Semana 16, Semana 24, Semana 28

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

Yes

E.6.7

Pharmacodynamic

Yes

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

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

Belgium

Finland

France

Hungary

Mexico

Poland

Russian Federation

Spain

Ukraine

United States

E.8.7

Trial has a data monitoring committee

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

The end of the study is defined as the date of the last patient's last visit (LPLV). The LPLV is expected to occur at a maximum of 28 weeks after the last patient is randomized.

El final del estudio se define como la fecha de la última visita del último paciente (UVUP). Se prevé que la UVUP tenga lugar un máximo de 28 semanas después de la aleatorización 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:

108

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

120

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)

Patients may be eligible to receive omalizumab as part of another available sponsor- permitted study of omalizumab in nasal polyps. The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following Web site: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf

Los pacientes pueden ser elegibles para recibir Omalizumab como parte de otro estudio permitido por el promotor que esté disponible de Omalizumab en polipos nasales. La politica global de Roche de acceso continuado a farmacos en investigación esta disponible en la siguiente página web: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf

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

2018-01-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-03-07

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IMP with orphan designation in the indication
Orphan Designation Number:
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