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

NCT04092582 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: GB411492019-000795-41
• Study Type: interventional
• Target: 135
• Locations: 5 countries
• Sites: 27

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Rate of Asthma Exacerbations

  Randomization [Week 2] to Week 50

• Time to First Asthma Exacerbation

  Randomization [Week 2] to Week 50

• Absolute Change From Randomization in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 50

  Randomization [Week 2] to Week 50

• Relative Percent Change From Randomization in Pre-Bronchodilator FEV1 at Week 50

  Randomization [Week 2] to Week 50

• Absolute Change From Randomization in Fractional Exhaled Nitric Oxide (FeNO) at Week 50

  Randomization [Week 2] to Week 50

Study Arms (2)

MTPS9579A

EXPERIMENTAL

Drug: MTPS9579A

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MTPS9579A DRUG

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

MTPS9579A

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (27)

Kern Research

Bakersfield, California, 93301, United States

Location

Allergy & Asthma Medical Group of the Bay Area

Walnut Creek, California, 94598, United States

Location

Florida Ctr-Allergy & Asthma

Miami, Florida, 33173, United States

Location

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

Toledo Inst of Clin Research

Toledo, Ohio, 43617, United States

Location

OK Clinical Research

Edmond, Oklahoma, 73034, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Fundacion Cidea

Buenos Aires, C1121ABE, Argentina

Location

Centro Médico Dra. Cristina de Salvo

Buenos Aires, C1426ABO, Argentina

Location

CARE - Centro de Alergia y Enfermedades Respiratorias

CABA, C1414AIF, Argentina

Location

Centro Respiratorio Quilmes

Quilmes, B1878FNR, Argentina

Location

Research Center for Medical Studies RCMS

Berlin, 10717, Germany

Location

IKF Pneumologie

Frankfurt am Main, 60596, Germany

Location

Pneumologicum

Hanover, 30173, Germany

Location

BAG Prof Dr G Hoheisel Dr A Bonitz

Leipzig, 04275, Germany

Location

SMO.MD GmbH, Zentrum für klinische Studien

Magdeburg, 39120, Germany

Location

Clinica Providencia (Inverconsult Sociedad Anonima)

Lima, 32, Peru

Location

Clinica Ricardo Palma; THORAX

Lima, Lima 27, Peru

Location

Centrum Medycyny Oddechowej Robert M. Mróz

Bialystok, 15-003, Poland

Location

Centrum Medyczne ALL-MED

Krakow, 30-033, Poland

Location

Malopolskie Centrum Alergologii

Krakow, 30-727, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lodz, 90-153, Poland

Location

Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik

Ostrowiec Swietokrzysk, 27-400, Poland

Location

Centrum Alergologii Teresa Hofman

Poznan, 60-214, Poland

Location

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

Sosnowiec, 41-200, Poland

Location

ALL-MED Specjalistyczna Opieka Medyczna

Wroclaw, 50-445, Poland

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Enrollment was halted on 08 April 2020 in response to the emerging pandemic and concerns regarding data integrity (e.g., missed study doses and visits). The trial was restarted on 22 June 2020.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: October 31, 2019
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

US (8); AR (4); DE (5); PL (8); PE (2)