A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE LEBRIKIZUMAB (MILR1444A) IN ADULT PATIENTS WITH ASTHMA WHO ARE NOT TAKING INHALED CORTICOSTEROIDS (MOLLY) - MOLLY
- Conditions
- Asthma in adult patients not taking inhaled corticosteroidsMedDRA version: 12.0Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2009-013267-19-HU
- Lead Sponsor
- GENENTECH, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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 <15% (increase or decrease).
Relative change in mean morning pre-bronchodilator peak flow between Visit 1 and 2 must be < 20% (increase or decrease) of the mean pre-bronchodilator peak flow between Visits 2 and 3.
Daily use of albuterol metered dose inhaler (MDI) (or equivalent) must be < 10 puffs or = 2 nonscheduled administrations (or any new use) of nebulized SABA therapy
No required ICS, oral or parenteral corticosteroids
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method