Clinical Trials Register

Summary
EudraCT Number:	2016-004315-13
Sponsor's Protocol Code Number:	CIGE025AMX02
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-05-08
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2016-004315-13

A.3

Full title of the trial

Multicentric, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12-MonthPeriod, in Patients with Severe IgE-mediated Asthma Inadequately Controlled with High Doses of Corticosteroids. MEXIC Study

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

MEXIC

A.4.1

Sponsor's protocol code number

CIGE025AMX02

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	Novartis
B.1.3.4	Country	Mexico
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	Novartis
B.4.2	Country	Mexico
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis pharma AG
B.5.2	Functional name of contact point	Clinical trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Forum 1, Novartis AG
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4056
B.5.3.4	Country	Switzerland
B.5.6	E-mail	clinicaltrial.enquiries@novartis.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 Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Switzerland
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	Xolair
D.3.2	Product code	IGE025
D.3.4	Pharmaceutical form	Powder and solvent 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.3.9.4	EV Substance Code	SUB12543MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15mg/2ml
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)	Yes
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

Difficult to control severe asthma

E.1.1.1

Medical condition in easily understood language

Severe asthma

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult patients with severe IgE-mediated asthma inadequately controlled with high doses of corticosteroids.)

E.2.2

Secondary objectives of the trial

·Number of clinically significant asthma exacerbations
Clinically significant asthma exacerbation episode include: moderate or severe asthma episodes that require evaluation and treatment at a medical office or urgent care or emergency room.
·Number of hospital admissions due to asthma exacerbation. Number of days of concomitant medications use reported by participants at all visits via diaries. ·
The ACQ has six questions to be answered by the patient, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. )

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria
•Male and female between 6 and 55 years old. If female, patient of childbearing potential must use a safe and efficacious birth control method.
•Asthma is considered as not well-controlled if patient has 3 or more of the following conditions:
a.Persistent day symptoms with current therapy twice at week or more, (siblings, dyspnea, cough, chest pain, thoracic oppression).
b.One or more night-time awakenings over the last 4 weeks.
c.Any limitation of age-appropriated habitual activities.
d.Need of rescue medication (short acting β2 agonist) for two or more occasions per week during the last 4 weeks before screening and 2 consecutives weeks within the 4 weeks before selection.
e.PEF or VEF1 <80% predicted or personal best (if known) this is not mandatory for pediatric patients (under 18 years old).

•Despite continuous treatment with high-dose inhaled corticosteroids (ICS) or oral corticosteroids (OCS) (CSO≥ 1 mg/kg/day) with or without controllers (As per GINA 2012 definition), the subject is receiving high doses of ICS (budesonide or its equivalent) and a long-acting β2-agonists(LABA) (formoterol) for the past 12 weeks at visit 0.
•At last one documented asthma exacerbation (defined as increase asthma symptoms requiring systemic corticosteroid rescue therapy) that requires visits to the emergency room or to be hospitalized in the past 12 months. It is also considered asthma exacerbation a non-planned visit that required rescue medication (β2-agonists and/or steroid nebulization every 20 minutes or β2-agonists inhaler shots every 20 minutes).
•Positive skin test or in vitro reactivity to a perennial aeroallergen, documented during the 12 months previous screening.
•IgE total concentration ranging from 30 to 1500 UI/ml.
•Body weight between 20 to 150 kg

E.4

Principal exclusion criteria

Exclusion Criteria
•Pregnant or lactating female or without safe and efficacious birth control method if of childbearing potential.
•Currently smokers or history of smoking 10 or more packs per year.
•Ex-smokers with a history of more than 10 years of smoking. As an exception, a patient with this criterion will be considered as eligible if the FEV1 reversibility of the first spirometry reaches 12%.
•Active lung disease other than asthma.
•Use of methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants, gammaglobulin or any other type of monoclonal antibody used during the 6 months prior to the initial visit.
•Use of omalizumab during the 4 months prior to de screening visit.
•History of renal disease, cardiovascular disease, metabolic disease, hematologic disease, gastrointestinal disease, as well as immunodeficiency or cerebrovascular disease currently under treatment but not-controlled.
•History of hepatic, neurologic, oncologic or autoimmune disease.
•Patient under suspicion of having cancer.
•Patients with history of hypersensitivity to sucrose, histidine, polysorbate 20 as well as to monoclonal antibodies or gammaglobulin.
•Hypersensitivity to omalizumab or its excipients.
•Abnormal values of the blood chemistry laboratory tests, over 2 times the upper limit normal, that are considered clinically significant.
•Underage patient or any patient under vulnerable conditions who does not live with their parents or legal guardian.

E.5 End points

E.5.1

Primary end point(s)

· Number of patients able to reduce the baseline budesonide/formoterol dosis [ Time Frame: baseline and up to 12 months ]
Number of patients able to reduce the baseline budesonide/formoterol dosis upon Weekly or every 2 weeks dose of omalizumab and daily dose of budesonide/formoterol taken since the previous visit

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline and up to 12 months

E.5.2

Secondary end point(s)

• Number of clinically significant asthma exacerbations [ Time Frame: 12 months ]
Clinically significant asthma exacerbation episode include: moderate or severe asthma episodes that require evaluation and treatment at a medical office or urgent care or emergency room.

• Number of hospital admissions due to asthma exacerbation. [ Time Frame: 12 months ]
A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours.

• Days missed in school/work due to asthma exacerbation episodes [ Time Frame: 12 months ]
Patient/parent/legal guarding reported number of missed days of school or work at each study visit via diaries.

• Use of oral/systemic corticosteroid for asthma exacerbation Treatment [ Time Frame: 12 months ]
Number of days of concomitant medications use reported by participants at all visits via diaries.

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline and up to 12 months

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

Yes

E.6.13.1

Other scope of the trial description

ICS reduction

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

other ICS

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Mexico

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

Premature closure

E.8.9 Initial estimate of the duration of the trial

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

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

138

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)

During the 8-week reduce steroid dose phase, adult and pediatric patients will reduce 25% ofthe budesonide/formoterol baseline dose every 2 weeks, depending of the asthma control,until reaching a 100% reduction of the baseline dose

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Mexico

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