Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lebrikizumab · 16 trials · 6 indications
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. The active comparator treatment arm of open-label montelukast was included in the study design so that the sensitivity of the study could be evaluated with respect to the primary outcome measure, FEV1. Two mixed-effect models of repeated measures (MMRM) were used to estimate the absolute change from baseline values: one for the lebrikizumab vs. placebo primary comparison and the second for the montelukast vs. placebo sensitivity comparison.
Asthma exacerbation is defined as new or increased asthma symptoms (i.e., wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to systemic corticosteroid (CS) treatment (oral, intravenous (IV), or intramuscular (IM) CS for ≥ 3 days or an emergency department visit with at least one dose of IV or IM CS) or to hospitalization. Results are reported as a 'Number' representing the model-adjusted incidence rate of asthma exacerbations per person-year. To account for early discontinuation, for each patient, the time at risk (in years) was computed as the duration of this time period (last day minus first day \[in days\] plus 1) divided by 365.25. The 'first day' was the day of randomization to the PCP. For patients entering the ATE, the 'last day' was the day prior to ATE randomization. For patients not entering the ATE, the 'last day' was at the last study visit on/prior to Study Day 379 (365 days plus a 14-day window).
Annualized rates of decrease (slope throughout time from baseline to Week 52) for percent predicted FVC was assessed and reported. FVC is a standard pulmonary function test. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = \[(observed FVC)/(predicted FVC)\]\*100.
| Arm | Type | Description |
|---|---|---|
| Lebrikizumab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Montelukast | ACTIVE_COMPARATOR | - |
| Lebrikizumab (125 mg) | EXPERIMENTAL | Participants will receive SC injection of lebrikizumab (125 mg) every 4 weeks for 104 weeks. |
| Lebrikizumab (37.5 mg) | EXPERIMENTAL | Participants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks. |
| Lebrikizumab: Biomarker-high | EXPERIMENTAL | Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high. |
| Lebrikizumab: Biomarker-low | EXPERIMENTAL | Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low. |
| Placebo: Biomarker-high | PLACEBO_COMPARATOR | Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high. |
| Placebo: Biomarker-low | PLACEBO_COMPARATOR | Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low. |
| Group 1: Lebrikizumab Dose Level 1 Monotherapy | EXPERIMENTAL | During the 2-week run-in period, participants will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 12-week treatment period, lebrikizumab monotherapy will be administered by subcutaneous (SC) injection, but participants assigned to this group will not receive topical corticosteroids. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator. |
| Group 2: Topical Corticosteroid Creams Only | ACTIVE_COMPARATOR | During the 2-week run-in period and during the 12-week treatment period, participants assigned to this group will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator. |
| Lebrikizumab 250 mg Single Dose + TCS Cream | EXPERIMENTAL | Participants will receive lebrikizumab 250 milligrams (mg) SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period. |
| Lebrikizumab 125 mg Single Dose + TCS Cream | EXPERIMENTAL | Participants will receive lebrikizumab 125 mg SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period. |
| Lebrikizumab 125 mg Q4W + TCS Cream | EXPERIMENTAL | Participants will receive lebrikizumab 125 mg SC every 4 weeks (Q4W) for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period. |
| Placebo Q4W + TCS Cream | PLACEBO_COMPARATOR | Participants will receive placebo Q4W for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period. |
| Lebrikizumab High Dose | EXPERIMENTAL | Participants will receive lebrikizumab at high dose level as subcutaneous (SC) injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period. |
| Lebrikizumab Low Dose | EXPERIMENTAL | Participants will receive lebrikizumab at low dose level as SC injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period. |
| Monotherapy (Cohort A): Placebo | PLACEBO_COMPARATOR | Participants will receive monotherapy with placebo matched to lebrikizumab administered via subcutaneous (SC) injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants will be allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period. |
| Monotherapy (Cohort A): Lebrikizumab | EXPERIMENTAL | Participants will receive monotherapy with lebrikizumab at a dose of 250 milligrams (mg) administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants will be allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period. |
| Combination Therapy (Cohort B): Placebo + Pirfenidone | PLACEBO_COMPARATOR | Participants will receive pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day \[9 capsules daily\] for a total of 2403 mg/day) or at maximum tolerated dose (MTD) administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | EXPERIMENTAL | Participants will receive pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day \[9 capsules daily\] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| lebrikizumab - highest dose | EXPERIMENTAL | - |
| lebrikizumab - lowest dose | EXPERIMENTAL | - |
| lebrikizumab - middle dose | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Treatment 1: Needle and Syringe | EXPERIMENTAL | Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe. |
| Treatment 2: PFS-NSD | EXPERIMENTAL | Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD. |
| Name | Type | Description |
|---|---|---|
| Lebrikizumab | DRUG | Lebrikizumab 125 mg subcutaneous (SC) injection given on Days 1, 29, and 57 |
| Montelukast | DRUG | 10 mg tablet given orally once daily for 12 weeks, according to the approved label. |
| Placebo | OTHER | Lebrikizumab-matched placebo SC injection given on Days 1, 29, and 57 |
| Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%) | DRUG | Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated. |
| TCS Cream | DRUG | TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily |
| Inhaled corticposteroids (ICS) | DRUG | Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS. |
| Second Asthma Controller Medication | DRUG | Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study. |
| Pirfenidone | DRUG | Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD. |
| lebrikizumab (MILR1444A) | DRUG | Subcutaneous repeating dose |
Inclusion Criteria: * Age 18-75 years old at study start * Asthma diagnosis for \>/= 12 months prior to study start * Bronchodilator response at screening * Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3 * No other clinically significant lung disease as confirmed by...
Lebrikizumab is an investigational drug being studied for several conditions, including allergic asthma, asthma, atopic dermatitis, idiopathic pulmonary fibrosis, and chronic obstructive pulmonary disease. It has also been evaluated in healthy volunteers. As of the latest data, it is in Phase 2 clinical development and is not approved by the FDA.
Lebrikizumab is a small molecule that targets interleukin-13 (IL-13), a cytokine involved in inflammatory responses. By modulating this pathway, it is being investigated for its potential to treat inflammatory and fibrotic conditions such as asthma, atopic dermatitis, and idiopathic pulmonary fibrosis.
Lebrikizumab is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications, including respiratory and dermatological conditions.
Lebrikizumab is currently in Phase 2 clinical development. It has completed nine trials, with no active trials ongoing at this time. The drug is investigational and has not received FDA approval for any indication.
Lebrikizumab has been studied in several completed clinical trials, including NCT00781443 for allergic asthma, NCT01423318 in healthy volunteers, NCT01872689 for idiopathic pulmonary fibrosis, and NCT02486809, a bioequivalence study in healthy volunteers. These trials have collectively enrolled over 3,600 participants.
Yes, Lebrikizumab is also known as MILR1444A. In clinical trial NCT00781443, the drug was referred to as MILR1444A, and it was evaluated for the prevention of allergen-induced airway obstruction in adults with mild allergic asthma.