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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID: NCT04092582
Run by: Genentech, Inc.
People needed: 135
Starts: 2019-10-31
Expected to finish: 2022-05-19
Last updated by the study team: 2023-08-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Kern Research — Bakersfield, California, United States
Allergy & Asthma Medical Group of the Bay Area — Walnut Creek, California, United States
Florida Ctr-Allergy & Asthma — Miami, Florida, United States
Florida Pulmonary Research Institute, LLC — Winter Park, Florida, United States
Toledo Inst of Clin Research — Toledo, Ohio, United States
OK Clinical Research — Edmond, Oklahoma, United States
Temple University Hospital — Philadelphia, Pennsylvania, United States
Spartanburg Medical Research — Spartanburg, South Carolina, United States
Fundacion Cidea — Buenos Aires, Argentina
Centro Médico Dra. Cristina de Salvo — Buenos Aires, Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias — CABA, Argentina
Centro Respiratorio Quilmes — Quilmes, Argentina
Research Center for Medical Studies RCMS — Berlin, Germany
IKF Pneumologie — Frankfurt am Main, Germany
Pneumologicum — Hanover, Germany
BAG Prof Dr G Hoheisel Dr A Bonitz — Leipzig, Germany
SMO.MD GmbH, Zentrum für klinische Studien — Magdeburg, Germany
Clinica Providencia (Inverconsult Sociedad Anonima) — Lima, Peru
Clinica Ricardo Palma; THORAX — Lima, Peru
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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.