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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2009-010359-28-HU |
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Date of registration:
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20/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF LEBRIKIZUMAB (MILR1444A)IN ADULT PATIENTS WITH ASTHMA WHO ARE INADEQUATELY CONTROLLED ON INHALED CORTICOSTEROIDS. - MILLY
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Scientific title:
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A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF LEBRIKIZUMAB (MILR1444A)IN ADULT PATIENTS WITH ASTHMA WHO ARE INADEQUATELY CONTROLLED ON INHALED CORTICOSTEROIDS. - MILLY |
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Date of first enrolment:
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23/09/2009 |
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Target sample size:
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210 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010359-28 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Hungary
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients must meet the following criteria to be eligible for study entry:
103 Age=18 to = 65 years at Visit 1.
105 Chest radiography within 12 months of visit 1 with evidence of clinically significant abnormality.
107 Uncontrolled asthma defined by all of the following criteria:
- Diagnosis of asthma >12 months.
- Bronchodilator response at Visit 1 or 2
- Pre-bronchodilator FEV1 = 40% and = 80% predicted at Visit 3
- Required daily use of ICS = 200 µg and = 1000 µg total daily dose of fluticasone propionate or equivalent for a minimum of 6 months prior to Visit 1
- Demonstrated on-going asthma symptoms assessed at the end of the run-in period by ACQ score = 1.5 (for symptoms over the week prior to visit 3) despite ICS compliance.
Are the trial subjects under 18? no
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Patients who meet any of the following criteria will be excluded from study entry:
a. Medical Conditions
201 Asthma exacerbation, significant airflow obstruction, or respiratory infection between visits 1 and 3.
202 Known malignancy or current evaluation for a potential malignancy. If treatment for a malignancy was completed at least 12 months prior to Visit 1 and no further treatment is anticipated by the patient’s oncologist during this study, then the patient may enroll.
203 Basal or squamous cell carcinoma diagnosed or inadequately treated less than 12 months before Visit 1.
204 Known immunodeficiency, including but not limited to HIV infection.
205 Pre-existing lung disease other than asthma, including active infections.
206 Clinically significant medical disease which is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study.
207 Patients with elevated IgE levels for reasons other than allergy (including but not limited to parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich, Syndrome).
b. Exposures
210 Current smoker or former smoker with a lifetime smoking history of > 10 pack years.
211 History of substance abuse that may impair or risk the patient’s full participation in the study in the judgment of the investigator.
212 Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30days or 5 halv-lives if the investigational agent, whichever is longer.
c.Medications
213 Prior allergic reaction during the use (or possible use if blinded study) of a monoclonal antibody.
214 See excluded concomitant and previously prescribed therapies in Table 1 of the protocol.
d.Reproductive Potential
215 Patients (males and females) of reproductive potential who are not willing to use a highly effective method of contraception for the duration of the study or are pregnant or lactating at the time of randomization.
216 Women with a positive serum pregnancy test.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Asthma in patients who are inadequately controlled by inhaled corticosteroids
MedDRA version: 9.1
Level: PT
Classification code 10003553
Term: Asthma
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Intervention(s)
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Product Name: LEBRIKIZUMAB
Product Code: MILR1444A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lebrikizumab
CAS Number: 953400-68-5
Current Sponsor code: MILR1444A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Main Objective: The main objectives for this study are as follows:
- To assess the efficacy of lebrikizumab in improving asthma control in patients with asthma who remain inadequately controlled despite therapy with Inhaled corticosteroids (ICS).
- To evaluate the safety of lebrikizumab in patients with asthma who remain inadequately controlled despite therapy with ICS.
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Primary end point(s): The primary efficacy outcome measure is the relative change in pre-bronchodilator FEV1 (volume) from baseline to Week 12.
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Secondary Objective: The secondary objectives of this study are as follows:
- To assess the efficacy of lebrikizumab in improving asthma control in patients with asthma who remain inadequately controlled despite therapy with ICS.
- To assess the efficacy of lebrikizumab in reducing the rate of exacerbations in patients with asthma who remain inadequately controlled despite therapy with ICS
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Secondary ID(s)
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ILR4646g
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2009-010359-28-CZ
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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