Clinical trial NCT04092582: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Official title: A Phase IIa, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to First Composite Asthma Exacerbations (CompEX) Event
timeFrame: Randomization [Week 2] to end of treatment (EOT) [Week 50]
Secondary outcomes:
measure: Rate of Asthma Exacerbations
timeFrame: Randomization [Week 2] to Week 50
measure: Time to First Asthma Exacerbation
timeFrame: Randomization [Week 2] to Week 50
measure: Absolute Change From Randomization in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 50
timeFrame: Randomization [Week 2] to Week 50
measure: Relative Percent Change From Randomization in Pre-Bronchodilator FEV1 at Week 50
timeFrame: Randomization [Week 2] to Week 50
measure: Absolute Change From Randomization in Fractional Exhaled Nitric Oxide (FeNO) at Week 50
timeFrame: Randomization [Week 2] to Week 50
measure: Relative Percent Change From Randomization in FeNO at Week 50
timeFrame: Randomization [Week 2] to Week 50
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately Week 58
measure: Area Under Concentration-Time Curve for the First Dosing Interval (AUClast) of MTPS9579A
timeFrame: Randomization [Week 2] to Week 6
measure: Maximum Serum Concentration (Cmax) for the First Dosing Interval of MTPS9579A
timeFrame: 2-hour post-dose on Week 2
measure: Steady State Cmax of MTPS9579A
timeFrame: 2-hour post-dose on Week 14
measure: Maximum Time to Serum Concentration (Tmax) of MTPS9579A
timeFrame: Pre-dose and 2-hour post-dose on Week 2
measure: Trough Serum Concentration (Ctrough) Accumulation Ratio of MTPS9579A
timeFrame: Predose on Weeks 6 and 14
measure: Steady State Ctrough of MTPS9579A
timeFrame: Pre-dose on Week 14
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) to MTPS9579A
timeFrame: Pre-dose Week 54
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Research
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Medical Group of the Bay Area
state: California
city: Miami
country: United States
facility: Florida Ctr-Allergy & Asthma
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Toledo
country: United States
facility: Toledo Inst of Clin Research
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
city: Buenos Aires
country: Argentina
facility: Centro Médico Dra. Cristina de Salvo
city: Caba
country: Argentina
facility: CARE - Centro de Alergia y Enfermedades Respiratorias
city: Quilmes
country: Argentina
facility: Centro Respiratorio Quilmes
city: Berlin
country: Germany
facility: Research Center for Medical Studies RCMS
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie
city: Hannover
country: Germany
facility: Pneumologicum
city: Leipzig
country: Germany
facility: BAG Prof Dr G Hoheisel Dr A Bonitz
city: Magdeburg
country: Germany
facility: SMO.MD GmbH, Zentrum für klinische Studien
city: Lima
country: Peru
facility: Clinica Providencia (Inverconsult Sociedad Anonima)
city: Lima
country: Peru
facility: Clinica Ricardo Palma; THORAX
city: Bialystok
country: Poland
facility: Centrum Medycyny Oddechowej Robert M. Mróz
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Ostrowiec Swietokrzysk
country: Poland
facility: Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik
city: Poznan
country: Poland
facility: Centrum Alergologii Teresa Hofman
city: Sosnowiec
country: Poland
facility: PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
city: Wroclaw
country: Poland
facility: ALL-MED Specjalistyczna Opieka Medyczna
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: