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A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Phase 2 trial testing MSTT1041A in Asthma in 517 participants. Completed in 26 July 2019.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 517 |
| Start date | 20 September 2016 |
| Primary completion | 5 April 2019 |
| Estimated completion | 26 July 2019 |
| Sites | 138 locations across New Zealand, South Africa, Russia, Ukraine, Peru, Belgium, Germany, Poland |
Hoffmann-La Roche — full company profile →
Adults 18 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
FEV1 measures how much air a person can exhale during the first second of a forced breath. Adjusted means are reported.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 107 | 47 – 167 |
| Astegolimab (MSTT1041A) 70mg | 130 | 70 – 191 |
| Astegolimab (MSTT1041A) 210mg | 154 | 93 – 215 |
| Astegolimab (MSTT1041A) 490mg | 172 | 110 – 234 |
Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | NA | 46.6 – NA |
| Astegolimab (MSTT1041A) 70mg | NA | NA – NA |
| Astegolimab (MSTT1041A) 210mg | NA | NA – NA |
| Astegolimab (MSTT1041A) 490mg | NA | NA – NA |
The AQLQ measures the functional problems (physical, emotional, social, and occupational) most troublesome to adults (17-70 years) with asthma. There are 32 questions in 4 domains - symptoms, activity limitation, emotional function, and environmental stimuli - scored on a 7 point scale, with 7= no impairment and 1= severely impaired. For this study, improvement achievement was defined as an increase of at least 0.5 points from baseline to week 54. Adjusted rates are reported.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 55.3 | |
| Astegolimab (MSTT1041A) 70mg | 64.8 | |
| Astegolimab (MSTT1041A) 210mg | 61.3 | |
| Astegolimab (MSTT1041A) 490mg | 68.9 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 44.7 | |
| Astegolimab (MSTT1041A) 70mg | 35.2 | |
| Astegolimab (MSTT1041A) 210mg | 38.7 | |
| Astegolimab (MSTT1041A) 490mg | 31.1 |
Adjusted mean values are all equal to zero.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0 | 0 – 0 |
| Astegolimab (MSTT1041A) 70mg | 0 | 0 – 0 |
| Astegolimab (MSTT1041A) 210mg | 0 | 0 – 0 |
| Astegolimab (MSTT1041A) 490mg | 0 | 0 – 0 |
The adjusted mean proportion of weeks without a nighttime awakening from baseline through week 54 are reported. The proportion of weeks is expressed as a percentage.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.4 | -0.7 – 1.5 |
| Astegolimab (MSTT1041A) 70mg | 0.4 | -0.7 – 1.5 |
| Astegolimab (MSTT1041A) 210mg | 0.3 | -0.7 – 1.3 |
| Astegolimab (MSTT1041A) 490mg | 0.3 | -0.7 – 1.3 |
The ADSD is a 6-item daily measure of asthma symptom severity that assesses three core categories of asthma symptoms: breathing symptoms, chest symptoms, and cough. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (no symptoms) to 10 (the worst symptoms imaginable). Adjusted means are reported.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1 | -2 – -1 |
| Astegolimab (MSTT1041A) 70mg | -2 | -2 – -1 |
| Astegolimab (MSTT1041A) 210mg | -1 | -2 – -1 |
| Astegolimab (MSTT1041A) 490mg | -1 | -2 – -1 |
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 77.2 | |
| Astegolimab (MSTT1041A) 70mg | 70.9 | |
| Astegolimab (MSTT1041A) 210mg | 72.2 | |
| Astegolimab (MSTT1041A) 490mg | 72.1 |
The prevalence of ADAs at baseline was defined as the proportion of the evaluable participant population in a study that is ADA positive at baseline.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 5.6 | |
| Astegolimab (MSTT1041A) 70mg | 0.8 | |
| Astegolimab (MSTT1041A) 210mg | 1.6 | |
| Astegolimab (MSTT1041A) 490mg | 1.7 |
| Group | Value | 95% CI |
|---|---|---|
| Astegolimab (MSTT1041A) 70mg | 4.75 | ± 123.3 |
| Astegolimab (MSTT1041A) 210mg | 16.9 | ± 167.3 |
| Astegolimab (MSTT1041A) 490mg | 40.5 | ± 161.2 |
| Group | Value | 95% CI |
|---|---|---|
| Astegolimab (MSTT1041A) 70mg | 4.47 | ± 144.1 |
| Astegolimab (MSTT1041A) 210mg | 17.4 | ± 155.4 |
| Astegolimab (MSTT1041A) 490mg | 38.7 | ± 226.4 |
The incidence of ADAs at post-baseline timepoints was defined as the proportion of the study population found to have developed treatment-emergent ADAs.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 7.1 | |
| Astegolimab (MSTT1041A) 70mg | 9.6 | |
| Astegolimab (MSTT1041A) 210mg | 8.9 | |
| Astegolimab (MSTT1041A) 490mg | 3.3 |
Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Adjusted rates for the overall mITT population (all participants that received at least one dose of study drug) were est
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.74 | |
| Astegolimab (MSTT1041A) 70mg | 0.47 | |
| Astegolimab (MSTT1041A) 210mg | 0.58 | |
| Astegolimab (MSTT1041A) 490mg | 0.42 |
Time frame: Baseline to Week 54. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Astegolimab (MSTT1041A) 70mg | Astegolimab (MSTT1041A) 21… | Astegolimab (MSTT1041A) 49… |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Atrial tachycardia | Cardiac disorders | — | — | — | — |
| Cataract | Eye disorders | — | — | — | — |
| Rectal haemorrhage | Gastrointestinal disorders | — | — | — | — |
| Chest pain | General disorders | — | — | — | — |
| Death | General disorders | — | — | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — | — | — |
| Drug-induced liver injury | Hepatobiliary disorders | — | — | — | — |
| Hepatotoxicity | Hepatobiliary disorders | — | — | — | — |
| Anaphylactic reaction | Immune system disorders | — | — | — | — |
| Bacteraemia | Infections and infestations | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — |
| Chronic sinusitis | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Pyelonephritis | Infections and infestations | — | — | — | — |
| Ankle fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Concussion | Injury, poisoning and procedural complications | — | — | — | — |
| Pubis fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Road traffic accident | Injury, poisoning and procedural complications | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Reaction | System | Placebo | Astegolimab (MSTT1041A) 70mg | Astegolimab (MSTT1041A) 21… | Astegolimab (MSTT1041A) 49… |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Injection site reaction | General disorders | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — |
| Rhinitis | Infections and infestations | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
Most-reported serious reactions: Asthma, Atrial fibrillation, Osteoarthritis, Pulmonary embolism, Atrial tachycardia, Cataract, Rectal haemorrhage, Chest pain.
Data from ClinicalTrials.gov NCT02918019 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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