Trial · NCT02918019
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
NCT02918019, Phase 2, Completed, Hoffmann-La Roche; results first posted 2022-12-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma. Trials, record NCT02918019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02918019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
- NCT number
- NCT02918019
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 517 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Asthma
- Interventions
- MSTT1041A, Placebo
- First posted
- 2016-09-28
- Last updated
- 2022-12-28
- Other registries' IDs
- eudract:2016-001549-13
- Results first posted
- 2022-12-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in Rate of Asthma Exacerbations | Baseline to Week 54 | 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 estimated using Poisson regression and adjusted for blood eosinophil level at the first visit, the number of asthma exacerbations requiring systemic corticosteroids in the 12 months prior to study entry, the total daily ICS dose at the first visit, and geographic region, with patient time at risk used as an offset term. |
| Secondary | Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Baseline to Week 54 | FEV1 measures how much air a person can exhale during the first second of a forced breath. Adjusted means are reported. |
| Secondary | Time to First Asthma Exacerbation | 52 Weeks | 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. |
| Secondary | Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score | Week 54 | 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. |
| Secondary | Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy | Baseline to Week 54 | Adjusted mean values are all equal to zero. |
| Secondary | Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings | Baseline through Week 54 | 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. |
| Secondary | Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD) | Baseline to Week 54 | 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. |
| Secondary | Percentage of Participants With Adverse Events | Baseline to Week 54 | 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. |
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) | Baseline | 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. |
| Secondary | Serum Concentration of Astegolimab (MSTT1041A) | Weeks 26 and 54 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Baseline to Week 54 | Milliliters (mL) | MEAN | |
| SECONDARY | Time to First Asthma Exacerbation | 52 Weeks | Weeks | MEDIAN | |
| SECONDARY | Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score | Week 54 | Percentage | NUMBER | |
| SECONDARY | Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy | Baseline to Week 54 | Usage | MEAN | |
| SECONDARY | Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings | Baseline through Week 54 | Percentage of weeks | MEAN | |
| SECONDARY | Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD) | Baseline to Week 54 | Scores on a scale | MEAN | |
| SECONDARY | Percentage of Participants With Adverse Events | Baseline to Week 54 | Percentage | NUMBER | |
| SECONDARY | Percentage of Participants With Anti-Drug Antibodies (ADAs) | Baseline | Percentage | NUMBER | |
| SECONDARY | Serum Concentration of Astegolimab (MSTT1041A) | Weeks 26 and 54 | The analysis population consisted of all PK-evaluable participants with at least one serum PK collected for the given treatment. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Treatment-Emergent ADAs | From baseline to the first appearance of ADAs at any point post-baseline (up to Week 54) | Percentage | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Placebo | 107 | 95% Confidence Interval 47 | Milliliters (mL) | |
| Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Astegolimab (MSTT1041A) 70mg | 130 | 95% Confidence Interval 70 | Milliliters (mL) | |
| Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Astegolimab (MSTT1041A) 210mg | 154 | 95% Confidence Interval 93 | Milliliters (mL) | |
| Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Astegolimab (MSTT1041A) 490mg | 172 | 95% Confidence Interval 110 | Milliliters (mL) | |
| Time to First Asthma Exacerbation | Placebo | NA | 95% Confidence Interval 46.6 to NA | Weeks | |
| Time to First Asthma Exacerbation | Astegolimab (MSTT1041A) 70mg | NA | 95% Confidence Interval NA to NA | Weeks | |
| Time to First Asthma Exacerbation | Astegolimab (MSTT1041A) 210mg | NA | 95% Confidence Interval NA to NA | Weeks | |
| Time to First Asthma Exacerbation | Astegolimab (MSTT1041A) 490mg | NA | 95% Confidence Interval NA to NA | Weeks | |
| Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score | Placebo | Week 54 - Responder | 55.3 | Percentage | |
| Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score | Astegolimab (MSTT1041A) 70mg | Week 54 - Responder | 64.8 | Percentage |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 127 | |
| Overall Study | STARTED | Astegolimab (MSTT1041A) 70mg | 127 | |
| Overall Study | STARTED | Astegolimab (MSTT1041A) 210mg | 126 | |
| Overall Study | STARTED | Astegolimab (MSTT1041A) 490mg | 122 | |
| Overall Study | COMPLETED | Placebo | 121 | |
| Overall Study | COMPLETED | Astegolimab (MSTT1041A) 70mg | 117 | |
| Overall Study | COMPLETED | Astegolimab (MSTT1041A) 210mg | 117 | |
| Overall Study | COMPLETED | Astegolimab (MSTT1041A) 490mg | 113 | |
| Overall Study | NOT COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Astegolimab (MSTT1041A) 70mg | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site reaction | General disorders | Placebo | 1 | 127 | 3 |
| other | Injection site reaction | General disorders | Astegolimab (MSTT1041A) 70mg | 10 | 127 | 38 |
| other | Injection site reaction | General disorders | Astegolimab (MSTT1041A) 210mg | 8 | 126 | 23 |
| other | Injection site reaction | General disorders | Astegolimab (MSTT1041A) 490mg | 6 | 122 | 107 |
| other | Influenza | Infections and infestations | Placebo | 5 | 127 | 5 |
| other | Influenza | Infections and infestations | Astegolimab (MSTT1041A) 70mg | 2 | 127 | 2 |
| other | Influenza | Infections and infestations | Astegolimab (MSTT1041A) 210mg | 2 | 126 | 2 |
| other | Influenza | Infections and infestations | Astegolimab (MSTT1041A) 490mg | 7 | 122 | 7 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 13 | 127 | 18 |
| other | Nasopharyngitis | Infections and infestations | Astegolimab (MSTT1041A) 70mg | 12 | 127 | 21 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 127 |
| Total, all-cause mortality | Astegolimab (MSTT1041A) 70mg | 0 | 127 |
| Total, all-cause mortality | Astegolimab (MSTT1041A) 210mg | 1 | 126 |
| Total, all-cause mortality | Astegolimab (MSTT1041A) 490mg | 1 | 122 |
| Total, other adverse events | Placebo | 76 | 127 |
| Total, other adverse events | Astegolimab (MSTT1041A) 70mg | 65 | 127 |
| Total, other adverse events | Astegolimab (MSTT1041A) 210mg | 75 | 126 |
| Total, other adverse events | Astegolimab (MSTT1041A) 490mg | 68 | 122 |
| Total, serious adverse events | Placebo | 8 | 127 |
| Total, serious adverse events | Astegolimab (MSTT1041A) 70mg | 14 | 127 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02918019
GET https://conductscience.org/api/trials/v1/NCT02918019/results?page=2