A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00971035

Acronym

MOLLY

Enrollment

210

Registered

2009-09-03

Start date

2009-11-30

Completion date

2011-02-28

Last updated

2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

MILR1444A

Brief summary

This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.

Interventions

DRUGlebrikizumab (MILR1444A)

Subcutaneous repeating dose

DRUGplacebo

Subcutaneous repeating dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Body weight ≥ 50 kg and ≤ 150 kg at Visit 1 * Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality * Stable asthma

Exclusion criteria

* Asthma exacerbation during screening * Known malignancy * Known immunodeficiency * Pre-existing lung disease other than asthma * Uncontrolled clinically significant medical disease * Current smoker * History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator * Prior allergic reaction to a monoclonal antibody * Patients (men and women) of reproductive potential who are not willing to use contraception * Pregnancy

Design outcomes

Primary

Measure	Time frame
Change in forced expiratory volume in 1 second (FEV1)	Baseline to Week 12

Secondary

Measure	Time frame
Change in quality of life and symptom scores	Baseline to Week 12
Change in peak flow	Baseline to Week 1
Rate of asthma exacerbations	During the 24-week treatment period
Change in pre-bronchodilator FEV1	Baseline to Week 24
Frequency and severity of adverse events	From the first study-specific procedure through the last observation visit
Incidence of human anti-therapeutic antibodies (ATA)	Baseline to Week 32
Change in rescue medication use	From baseline to Week 1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026