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

NCT ID: NCT04092582

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2022-05-19

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MTPS9579A

Group Type: EXPERIMENTAL

MTPS9579A

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

MTPS9579A

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

Sosnowiec, , Poland

ALL-MED Specjalistyczna Opieka Medyczna

Wroclaw, , Poland

Countries

United States; Argentina; Germany; Peru; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-000795-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GB41149

Identifier Type: -

Identifier Source: org_study_id