Phase 2
N=502
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02918019 ↗Enrolled (actual)
502
Serious AEs
7.4%
Results posted
Dec 2022
Primary outcome: Primary: Reduction in Rate of Asthma Exacerbations — 0.74; 0.47; 0.58; 0.42 Number of asthma exacerbations per year — p=0.0049
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MSTT1041A (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Rate of Asthma Exacerbations |
0.74; 0.47; 0.58; 0.42 | 0.0049 sig |
| SECONDARY Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
107; 130; 154; 172 | — |
| SECONDARY Time to First Asthma Exacerbation |
NA; NA; NA; NA | — |
| SECONDARY Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score |
55.3; 64.8; 61.3; 68.9; 44.7; 35.2 | — |
| SECONDARY Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy |
0; 0; 0; 0 | — |
| SECONDARY Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings |
0.4; 0.4; 0.3; 0.3 | — |
| SECONDARY Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD) |
-1; -2; -1; -1 | — |
| SECONDARY Percentage of Participants With Adverse Events |
77.2; 70.9; 72.2; 72.1 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibodies (ADAs) |
5.6; 0.8; 1.6; 1.7 | — |
| SECONDARY Serum Concentration of Astegolimab (MSTT1041A) |
4.75; 16.9; 40.5; 4.47; 17.4; 38.7 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent ADAs |
7.1; 9.6; 8.9; 3.3 | — |
Summary
This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The total duration of this study for each participant is approximately 70 weeks including screening, run-in, treatment, and follow-up.
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) of 18 to 38 kilogram/square meter (kg/m^2) and weight >= 40 kg at screening
- Documented physician-diagnosed asthma
- On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
- Forced expiratory volume in 1 second (FEV1) of 40% to 80% of predicted
- Evidence of uncontrolled asthma
- Use of contraceptive measures
Exclusion Criteria
- Diagnosis of mimics of asthma
- Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma chronic obstructive pulmonary disease overlap syndrome, or bronchiolitis, as determined by the investigator
- Pregnant or lactating, or intending to become pregnant during the study or within 20 weeks after the last dose of MSTT1041A
- Recent history of smoking
- History or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, have an impact on the study results
- Asthma exacerbation within 4 weeks prior to screening
- Intubation for respiratory failure due to asthma within 12 months prior to screening
- Comorbid conditions that may interfere with evaluation of investigational medicinal product
- Known sensitivity to any of the active substances or their excipients to be administered during dosing
- Positive pregnancy test
Data sourced from ClinicalTrials.gov (NCT02918019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.