Asthma in adult patients not taking inhaled corticosteroids MedDRA version: 12.0 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
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 u
Sponsors
GENENTECH, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria to be eligible for study entry: 103 Age = 18 and = 65 years at Visit 1 105 Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality other than changes consistent with asthma 107 Stable asthma defined by the following criteria (patients must meet all of the criteria): 1. Diagnosis of asthma = 12 months prior to Visit 1 2. Bronchodilator response at Visit 1 or Visit 2 3. Prebronchodilator FEV1 = 60% and =85% predicted at Visit 3 4. Stable disease: Relative change in pre-bronchodilator FEV1 (volume) from Visit 2 to Visit 3 is =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: a.Medical Conditions 201 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. 202 Patients with a new diagnosis of basal cell carcinoma or squamous cell skin carcinoma in the 12 months prior to the run-in period are excluded. 203 Known immunodeficiency, including but not limited to HIV infection 204 Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study 205 Patients with elevated IgE levels for reasons other than allergy (including but not limited to parasitic infections, hyperimmunoglobulin E syndrome, allergic bronchopulmonary aspergillosis, and Wiskott-Aldrich syndrome) 206 Patients with a history of or active infection with any GI nematodes (including, though not limited to, enterobiasis; trichuriasis; hookworm; strongyloidiasis; trichinellosis; ascariasis) or leishmaniasis or lymphatic filariasis; regardless of treatment status 207 Any other medical condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications 209 Lung disease other than asthma including but not limited to active infection 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 interventional studies that does not include use of medication) within 30 days c.Medications 213 Use of any of the excluded medications during the time periods listed in Table 1 of protocol 214 Prior allergic reaction during the use (or possible use if blinded study) of a monoclonal antibody d. Reproductive Potential 215 Patients (men and women) of reproductive potential who are not willing to use a highly effective method of contraception (see Appendix B) for the duration of the study or women who are pregnant or lactating at the time of random allocation 216 Women with a positive serum pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives of this study are as follows; - To evaluate the efficacy of different doses of lebrikizumab compared with placebo as measured by relative change in pre-bronchodilator FEV1. - To evaluate the safety and tolerability of different doses of lebrikizumab. ;Secondary Objective: The secondary objectives of this study are as follows: - To compare the efficacy among different doses of lebrikizumab as measured by relative change in pre-bronchodilator FEV1. - To evaluate the efficacy of different doses of lebrikizumab compared with placebo in a subgroup of IL-13 signature surrogate positive patients, as measured by relative change in pre-bronchodilator FEV1. - To evaluate the efficacy of different doses of lebrikizumab compared with placebo as measured by change in morning peak flow, peak flow variability, rescue medication use, and time to treatment failure. - To characterize the PK of lebrikizumab. ;Primary end point(s): The primary efficacy outcome measure is the relative change in pre-bronchodilator FEV1 (volume) from baseline to Week 12. | — |
Countries
Hungary
Outcome results
None listed