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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04092582
Other study ID # GB41149
Secondary ID 2019-000795-41
Status Completed
Phase Phase 2
First received
Last updated
Start date October 31, 2019
Est. completion date May 19, 2022

Study information

Verified date August 2023
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase IIa, randomized, placebo-controlled, double-blind, multicenter, two-arm study to evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A as an add-on therapy in patients with uncontrolled moderate to severe asthma who are receiving daily ICS therapy and at least one of the following additional controller medications: long-acting beta-agonist (LABA), leukotriene modulator (leukotriene modifier [LTM] or leukotriene receptor antagonist [LTRA]), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date May 19, 2022
Est. primary completion date May 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Documented physician-diagnosed asthma for at least 12 months prior to screening - Treatment with asthma controller therapy (daily ICS [fluticasone propionate or equivalent] and at least one additional controller therapy [LABA, LAMA, LTM/LTRA]) for >= 3 months prior to screening, with no changes within 4 weeks prior to screening or during the screening period and no anticipated changes in controller dosing regimens throughout the study - Documented history of >= 2 asthma exacerbation within the 12 months prior to screening while on daily ICS maintenance therapy - For women of childbearing potential: agreement to remain abstinent or use contraception For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: - History or evidence of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation associated with panic attacks, or other mimics of asthma - History or evidence of significant respiratory disease other than asthma, including occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome, bronchiolitis, interstitial lung disease, or COPD - Current smoker, electronic cigarette (e-cigarette) user, former smoker with smoking history of > 10 pack-years, former e-cigarette user with an e-cigarette history of at least daily use for >=10 years, or unwilling to abstain from smoking and/or e-cigarette use from the time of consent through the completion of the study - History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, precludes the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study - Active malignancy or history of malignancy within 5 years of screening, except for appropriately treated non-melanoma skin carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or Stage I uterine cancer - Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of MTPS9579A - Positive for TB at screening

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MTPS9579A
MTPS9579A IV infusion will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks through Week 46.
Placebo
Placebo matching MTPS9579A will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks thereafter through Week 46.

Locations

Country Name City State
Argentina Centro Médico Dra. Cristina de Salvo Buenos Aires
Argentina Fundacion Cidea Buenos Aires
Argentina CARE - Centro de Alergia y Enfermedades Respiratorias Caba
Argentina Centro Respiratorio Quilmes Quilmes
Germany Research Center for Medical Studies RCMS Berlin
Germany IKF Pneumologie Frankfurt am Main
Germany Pneumologicum Hannover
Germany BAG Prof Dr G Hoheisel Dr A Bonitz Leipzig
Germany SMO.MD GmbH, Zentrum für klinische Studien Magdeburg
Peru Clinica Providencia (Inverconsult Sociedad Anonima) Lima
Peru Clinica Ricardo Palma; THORAX Lima
Poland Centrum Medycyny Oddechowej Robert M. Mróz Bialystok
Poland Centrum Medyczne ALL-MED Krakow
Poland Malopolskie Centrum Alergologii Krakow
Poland SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Lodz
Poland Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik Ostrowiec Swietokrzysk
Poland Centrum Alergologii Teresa Hofman Poznan
Poland PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna Sosnowiec
Poland ALL-MED Specjalistyczna Opieka Medyczna Wroclaw
United States Kern Research Bakersfield California
United States OK Clinical Research Edmond Oklahoma
United States Florida Ctr-Allergy & Asthma Miami Florida
United States Temple University Hospital Philadelphia Pennsylvania
United States Spartanburg Medical Research Spartanburg South Carolina
United States Toledo Inst of Clin Research Toledo Ohio
United States Allergy & Asthma Medical Group of the Bay Area Walnut Creek California
United States Florida Pulmonary Research Institute, LLC Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Germany,  Peru,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Composite Asthma Exacerbations (CompEX) Event 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.
Randomization [Week 2] to end of treatment (EOT) [Week 50]
Secondary Rate of Asthma Exacerbations 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. Randomization [Week 2] to Week 50
Secondary Time to First Asthma Exacerbation 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. Randomization [Week 2] to Week 50
Secondary Absolute Change From Randomization in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 50 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. Randomization [Week 2] to Week 50
Secondary Relative Percent Change From Randomization in Pre-Bronchodilator FEV1 at Week 50 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. Randomization [Week 2] to Week 50
Secondary Absolute Change From Randomization in Fractional Exhaled Nitric Oxide (FeNO) at Week 50 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. Randomization [Week 2] to Week 50
Secondary Relative Percent Change From Randomization in FeNO at Week 50 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. Randomization [Week 2] to Week 50
Secondary Percentage of Participants With Adverse Events 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. Up to approximately Week 58
Secondary Area Under Concentration-Time Curve for the First Dosing Interval (AUClast) of MTPS9579A Randomization [Week 2] to Week 6
Secondary Maximum Serum Concentration (Cmax) for the First Dosing Interval of MTPS9579A 2-hour post-dose on Week 2
Secondary Steady State Cmax of MTPS9579A 2-hour post-dose on Week 14
Secondary Maximum Time to Serum Concentration (Tmax) of MTPS9579A Pre-dose and 2-hour post-dose on Week 2
Secondary Trough Serum Concentration (Ctrough) Accumulation Ratio of MTPS9579A The accumulation ratio is calculated by taking the individual ratio of the Ctrough at Week 14 to the Ctrough at Week 6. Predose on Weeks 6 and 14
Secondary Steady State Ctrough of MTPS9579A Pre-dose on Week 14
Secondary Percentage of Participants With Anti-Drug Antibodies (ADA) to MTPS9579A 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. Pre-dose Week 54
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