Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller (NCT NCT04092582)

NCT ID: NCT04092582

Last Updated: 2023-08-14

Results Overview

CompEX is defined as time from randomization to first asthma exacerbation or diary worsening during the treatment period. Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted 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. Diary worsening is based on the occurrence of prespecified changes in the following six parameters: morning peak expiratory flow rate (PEFR), evening PEFR, morning symptom score, evening symptom score, morning short-acting rescue therapy use, and evening short-acting rescue therapy use. Hazard ratio was used for the analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 135 participants
• Primary outcome timeframe: Randomization [Week 2] to end of treatment (EOT) [Week 50]
• Results posted on: 2023-08-14

Participant Flow

Participants took part in the study at 26 investigative sites in 5 countries (Argentina, Germany, Peru, Poland, and the United States) from 31 October 2019 to 19 May 2022.

This study included a 2-week single-blind placebo run-in period. A total of 135 participants were randomized in double-blind treatment period. Of the 135 participants randomized, 134 participants received at least one dose of study drug and their intended treatment.

Participant milestones

Measure	MTPS9579A, 1800 mg Participants with uncontrolled moderate to severe asthma received Placebo, given as intravenous (IV) infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Overall Study STARTED	69	66
Overall Study Safety Population	69	65
Overall Study COMPLETED	64	63
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	MTPS9579A, 1800 mg Participants with uncontrolled moderate to severe asthma received Placebo, given as intravenous (IV) infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Overall Study Death	1	1
Overall Study Withdrawal by Subject	4	1
Overall Study Enrolled but Failed to Meet Randomization Criteria; Excluded from Study Analysis	0	1

Baseline Characteristics

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller

Baseline characteristics by cohort

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A,1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=65 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Total n=134 Participants Total of all reporting groups
Age, Continuous	54.7 years STANDARD_DEVIATION 12.0 • n=5 Participants	52.9 years STANDARD_DEVIATION 13.2 • n=7 Participants	53.8 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	34 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants	53 Participants n=7 Participants	112 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization [Week 2] to end of treatment (EOT) [Week 50]

Population: Modified Intent-to-Treat population (mITT) population included all randomized participants who received at least one dose of study treatment.

CompEX is defined as time from randomization to first asthma exacerbation or diary worsening during the treatment period.

Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted 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. Diary worsening is based on the occurrence of prespecified changes in the following six parameters: morning peak expiratory flow rate (PEFR), evening PEFR, morning symptom score, evening symptom score, morning short-acting rescue therapy use, and evening short-acting rescue therapy use. Hazard ratio was used for the analysis.

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=65 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Time to First Composite Asthma Exacerbations (CompEX) Event	NA weeks Interval 31.3 to The data for median upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.	45.4 weeks Interval 19.0 to The data for upper limit of CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Randomization [Week 2] to Week 50

Population: mITT population included all randomized participants who received at least one dose of study treatment.

The number of asthma exacerbations per year was reported for this outcome measure. Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted 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. Poisson regression was used for the analysis.

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=65 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Rate of Asthma Exacerbations	0.4689 Asthma exacerbations per patient-year	0.4267 Asthma exacerbations per patient-year

SECONDARY outcome

Timeframe: Randomization [Week 2] to Week 50

Population: mITT population included all randomized participants who received at least one dose of study treatment.

The time from randomization to first asthma exacerbation was measured. Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted 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. Cox regression was used for the analysis.

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=65 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Time to First Asthma Exacerbation	NA weeks The data for median, lower and upper limit of CI was not estimable due to insufficient number of participants with events.	NA weeks The data for median, lower and upper limit of CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Randomization [Week 2] to Week 50

Population: mITT population included all randomized participants who received at least one dose of study treatment. Overall number of participants analyzed are the number of participants available for analysis.

FEV1 is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Estimates are based on a mixed model for repeated measures (MMRM) analysis with an unstructured covariance matrix. The model used the absolute change pre-bronchodilator FEV1 as the response variable and included terms for treatment arm, study visit, treatment arm by study visit interaction, baseline FEV1 as well as its interaction with study visit, in addition to the stratification factors: blood eosinophil level at visit 1 (<150, >=150 to <=300, >300 cells/microliter (uL)), number of asthma exacerbations requiring the use of systemic corticosteroids within the 12 months prior to the study entry (1 or >=2 events), and geographic region.

Outcome measures

Measure	MTPS9579A, 1800 mg n=62 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=61 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Absolute Change From Randomization in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 50	0.11 liters Standard Error 0.034	0.03 liters Standard Error 0.034

SECONDARY outcome

Timeframe: Randomization [Week 2] to Week 50

Population: mITT population included all randomized participants who received at least one dose of study treatment. Overall number of participants analyzed are the number of participants available for analysis.

FEV1 was the volume of air exhaled in the first second of a forced exhalation as measured by spirometer. Measurements were performed before use of bronchodilator. Estimates are based on a mixed model for repeated measures (MMRM) analysis with an unstructured covariance matrix. The model used the relative change pre-bronchodilator FEV1 as the response variable and included terms for treatment arm, study visit, treatment arm by study visit interaction, baseline FEV1 as well as its interaction with study visit, in addition to the stratification factors: blood eosinophil level at visit 1 (<150, >=150 to <=300, >300 cells/uL), number of asthma exacerbations requiring the use of systemic corticosteroids within the 12 months prior to the study entry (1 or >=2 events), and geographic region. Relative change (%) in FEV1 = (absolute change in FEV1 / baseline FEV1) x 100.

Outcome measures

Measure	MTPS9579A, 1800 mg n=62 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=61 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Relative Percent Change From Randomization in Pre-Bronchodilator FEV1 at Week 50	6.44 percent change Standard Error 1.894	3.15 percent change Standard Error 1.921

SECONDARY outcome

Timeframe: Randomization [Week 2] to Week 50

Population: mITT population included all randomized participants who received at least one dose of study treatment. Overall number of participants analyzed are the number of participants available for analysis.

FeNO is a volatile marker of airway inflammation that decreases with inhaled corticosteroid treatment. The measurements recorded were according to standardized procedures by the American Thoracic Society. Estimates are based on a mixed model for repeated measures (MMRM) analysis with an unstructured covariance matrix. The model used the absolute change pre-bronchodilator FeNO as the response variable and included terms for treatment arm, study visit, treatment arm by study visit interaction, baseline FeNO as well as its interaction with study visit, in addition to the stratification factors: blood eosinophil level at visit 1 (<150, >=150 to <=300, >300 cells/uL), number of asthma exacerbations requiring the use of systemic corticosteroids within the 12 months prior to the study entry (1 or >=2 events), and geographic region.

Outcome measures

Measure	MTPS9579A, 1800 mg n=57 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=54 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Absolute Change From Randomization in Fractional Exhaled Nitric Oxide (FeNO) at Week 50	-1.67 parts per billion (ppb) Standard Error 2.722	-1.52 parts per billion (ppb) Standard Error 2.791

SECONDARY outcome

Timeframe: Randomization [Week 2] to Week 50

Population: mITT population included all randomized participants who received at least one dose of study treatment. Overall number of participants analyzed are the number of participants available for analysis.

FeNO is a volatile marker of airway inflammation that decreases with inhaled corticosteroid treatment. The measurements recorded were according to standardized procedures by the American Thoracic Society. Relative change (%) in FeNO = (absolute change in FeNO / baseline FeNO) x 100. Estimates are based on a mixed model for repeated measures (MMRM) analysis with an unstructured covariance matrix. The model used the absolute change pre-bronchodilator FeNO as the response variable and included terms for treatment arm, study visit, treatment arm by study visit interaction, baseline FeNO as well as its interaction with study visit, in addition to the stratification factors: blood eosinophil level at visit 1 (<150, >=150 to <=300, >300 cells/uL), number of asthma exacerbations requiring the use of systemic corticosteroids within the 12 months prior to the study entry (1 or >=2 events), and geographic region.

Outcome measures

Measure	MTPS9579A, 1800 mg n=57 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=54 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Relative Percent Change From Randomization in FeNO at Week 50	26.02 percent change Standard Error 10.223	26.29 percent change Standard Error 10.482

SECONDARY outcome

Timeframe: Up to approximately Week 58

Population: The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=65 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Percentage of Participants With Adverse Events	79.7 percentage of participants	86.2 percentage of participants

SECONDARY outcome

Timeframe: Randomization [Week 2] to Week 6

Population: PK-evaluable population includes all participants who had at least one evaluable PK sample

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Area Under Concentration-Time Curve for the First Dosing Interval (AUClast) of MTPS9579A	5263.14 day*ug/mL Geometric Coefficient of Variation 83.6	—

SECONDARY outcome

Timeframe: 2-hour post-dose on Week 2

Population: PK-evaluable population includes all participants who had at least one evaluable PK sample.

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Maximum Serum Concentration (Cmax) for the First Dosing Interval of MTPS9579A	419 ug/mL Geometric Coefficient of Variation 51.4	—

SECONDARY outcome

Timeframe: 2-hour post-dose on Week 14

Population: PK-evaluable population includes all participants who had at least one evaluable PK sample

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Steady State Cmax of MTPS9579A	735 ug/mL Geometric Coefficient of Variation 31.0	—

SECONDARY outcome

Timeframe: Pre-dose and 2-hour post-dose on Week 2

Population: PK-evaluable population includes all participants who had at least one evaluable PK sample.

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Maximum Time to Serum Concentration (Tmax) of MTPS9579A	0.12 day Standard Deviation 3.41	—

SECONDARY outcome

Timeframe: Predose on Weeks 6 and 14

Population: PK-evaluable population includes all participants who had at least one evaluable PK sample.

The accumulation ratio is calculated by taking the individual ratio of the Ctrough at Week 14 to the Ctrough at Week 6.

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Trough Serum Concentration (Ctrough) Accumulation Ratio of MTPS9579A	1.93 ratio Geometric Coefficient of Variation 28.3	—

SECONDARY outcome

Timeframe: Pre-dose on Week 14

Population: PK-evaluable population includes all participants who had at least one evaluable PK sample.

Outcome measures

Measure	MTPS9579A, 1800 mg n=69 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Steady State Ctrough of MTPS9579A	226 ug/mL Geometric Coefficient of Variation 45.4	—

SECONDARY outcome

Timeframe: Pre-dose Week 54

Population: The immunogenicity analysis population included all participants with at least one ADA assessment.

Treatment Emergent ADA is (a) negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result, OR (b) positive ADA result at baseline and one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result.

Outcome measures

Measure	MTPS9579A, 1800 mg n=68 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=65 Participants Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Percentage of Participants With Anti-Drug Antibodies (ADA) to MTPS9579A	5.9 percentage of participants	0 percentage of participants

Adverse Events

MTPS9579A, 1800 mg

Serious events: 5 serious events

Other events: 32 other events

Deaths: 1 deaths

Placebo

Serious events: 4 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Measure	MTPS9579A, 1800 mg n=69 participants at risk Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=65 participants at risk Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
General disorders Accidental death	1.4% 1/69 • Number of events 1 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	0.00% 0/65 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Infections and infestations COVID-19	1.4% 1/69 • Number of events 1 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	0.00% 0/65 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Infections and infestations COVID-19 pneumonia	0.00% 0/69 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	4.6% 3/65 • Number of events 3 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Injury, poisoning and procedural complications Clavicle fracture	1.4% 1/69 • Number of events 1 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	0.00% 0/65 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/69 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	1.5% 1/65 • Number of events 1 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.4% 1/69 • Number of events 1 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	0.00% 0/65 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Skin and subcutaneous tissue disorders Dermatitis	1.4% 1/69 • Number of events 1 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	0.00% 0/65 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.

Other adverse events

Measure	MTPS9579A, 1800 mg n=69 participants at risk Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.	Placebo n=65 participants at risk Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Infections and infestations COVID-19	8.7% 6/69 • Number of events 6 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	9.2% 6/65 • Number of events 6 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Infections and infestations Nasopharyngitis	5.8% 4/69 • Number of events 5 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	7.7% 5/65 • Number of events 5 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 3/69 • Number of events 3 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	6.2% 4/65 • Number of events 4 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/69 • Number of events 1 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	6.2% 4/65 • Number of events 4 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Nervous system disorders Headache	7.2% 5/69 • Number of events 6 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	4.6% 3/65 • Number of events 3 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Respiratory, thoracic and mediastinal disorders Asthma	27.5% 19/69 • Number of events 31 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	36.9% 24/65 • Number of events 33 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/69 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.	6.2% 4/65 • Number of events 5 • Up to approximately Week 58 All cause mortality data was collected for all enrolled participants and serious adverse events (SAE) and other adverse events (AE) was collected for Safety analysis population. The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period.

Additional Information

Medical Communications

Hoffmann-La Roche

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Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER