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

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ClinicalTrials.gov Identifier: NCT04092582
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: MTPS9579A Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: MTPS9579A Drug: MTPS9579A
MTPS9579A IV infusion will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks through Week 46.

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




Primary Outcome Measures :
  1. Time to First CompEx Event [ Time Frame: Randomization visit [Week 2] to end of treatment [Week 50] ]
    A composite endpoint is defined as time from randomization to first asthma exacerbation or diary worsening


Secondary Outcome Measures :
  1. Rate of Asthma Exacerbations, as Assessed by the Investigator [ Time Frame: From randomization visit [Week 2] to end of treatment [Week 50] ]
  2. Time to First Asthma Exacerbation [ Time Frame: From randomization visit [Week 2] to end of treatment [Week 50] ]
  3. Absolute and Relative Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: From randomization visit [Week 2] to end of treatment [Week 50] ]
  4. Absolute and Relative Change in Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: Randomization [Week 2] to end of treatment [Week 50] ]
  5. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately Week 58 ]
  6. Serum Concentration of MTPS9579A [ Time Frame: Days 15, 23, 44, 72, 100, 156, 212, 268, 352 ]
  7. Percentage of Participants with Anti-Drug Antibodies (ADAs) [ Time Frame: Up to week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 >= 1 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, former smoker with smoking history of > 10 pack-years, or unwilling to abstain from smoking 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 42 days after the final dose of MTPS9579A
  • Positive for TB at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092582


Contacts
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Contact: Reference Study ID Number: GB41149 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Locations
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United States, California
Kern Research Recruiting
Bakersfield, California, United States, 93301
Jonathan Corren MD, Inc. Recruiting
Los Angeles, California, United States, 90025
Allergy & Asthma Medical Group of the Bay Area Recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
IMMUNOe Research Centers Recruiting
Centennial, Colorado, United States, 80112
United States, Connecticut
Winchester Chest Clinic Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Florida Ctr-Allergy & Asthma Not yet recruiting
Miami, Florida, United States, 33173
Florida Pulmonary Research Institute, LLC Recruiting
Winter Park, Florida, United States, 32789
United States, Missouri
Washington Univ. School of Med Not yet recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Nebraska Medical Research Institute, Inc. - CRN Not yet recruiting
Bellevue, Nebraska, United States, 68123
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10461
United States, Ohio
Asthma & Allergy Center Not yet recruiting
Toledo, Ohio, United States, 43617
United States, Oklahoma
OK Clinical Research Recruiting
Edmond, Oklahoma, United States, 73034
Vital Prospects Clinical Research Institute PC - CRN Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Temple University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Spartanburg Medical Research Recruiting
Spartanburg, South Carolina, United States, 29303
United States, Texas
AARA Research Center - CRN Withdrawn
Dallas, Texas, United States, 75231
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Metroplex Pulmonology & Sleep Center Not yet recruiting
McKinney, Texas, United States, 75069
South Texas Allergy and Asthma Medical Professionals Recruiting
San Antonio, Texas, United States, 78251
Argentina
Centro Médico Vitae Not yet recruiting
Buenos Aires, Argentina, B6500BWQ
Instituto de Investigaciones Clinicas-Mar del Plata Not yet recruiting
Buenos Aires, Argentina, B7600FZN
Fundacion Cidea Not yet recruiting
Buenos Aires, Argentina, C1125 ABE
Centro Médico Dra. Cristina de Salvo Not yet recruiting
Buenos Aires, Argentina, C1426ABO
CARE - Centro de Alergia y Enfermedades Respiratorias Not yet recruiting
Caba, Argentina, C1414AIF
Centro Dr. Lazaro Langer Not yet recruiting
Cordoba, Argentina, X5003DCE
Framingham Centro Medico Not yet recruiting
La Plata, Argentina, 1900
Instituto Ave Pulmo Not yet recruiting
Mar Del Plata, Argentina, CP 7600
INSARES Not yet recruiting
Mendoza, Mendoza City, Argentina, M5500CCG
Centro Médico Dharma Not yet recruiting
Mendoza, Argentina, 5500
Centro Respiratorio Quilmes Not yet recruiting
Quilmes, Argentina, 1878
Centro Integral de Medicina Respiratoria (CIMER) Not yet recruiting
San Miguel de Tucumán, Argentina, T4000CHE
Consultorio Médico Centro Investigación Médica Respiratoria Oncológica Not yet recruiting
San Rafael, Argentina, 5600
Peru
Hospital Chancay y Servicios Basicos de Salud Not yet recruiting
Huaral, Peru, 15131
Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias Not yet recruiting
Lima, Peru, 15088
Clinica Internacional Not yet recruiting
Lima, Peru, Lima 1
Clinica Ricardo Palma; THORAX Not yet recruiting
Lima, Peru, Lima 27
Hospital Santa Rosa Piura Not yet recruiting
Piura, Peru, 20001
Poland
Centrum Medycyny Oddechowej Robert M. Mróz Not yet recruiting
Bialystok, Poland, 15-003
10 Wojskowy Szpital Kliniczny z Poliklinika; Oddzial Kliniczny Pulmonologii i Alergologii Not yet recruiting
Bydgoszcz, Poland, 85-811
Centrum Medyczne ALL-MED Not yet recruiting
Krakow, Poland, 30-033
Malopolskie Centrum Alergologii Not yet recruiting
Krakow, Poland, 31-624
Centrum Opieki Zdrowotnej Orkan-Med Not yet recruiting
Ksawerow, Poland, 95-054
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Not yet recruiting
Lodz, Poland, 90-153
Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik Not yet recruiting
Ostrowiec Swietokrzysk, Poland, 27-400
Centrum Alergologii Teresa Hofman Not yet recruiting
Poznan, Poland, 60-214
PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C. Not yet recruiting
Sosnowiec, Poland, 41-200
Alergo Medical Specjalistyczna Przychodnia Lekarska Not yet recruiting
Tarnow, Poland, 33-100
Centrum Medyczne Pratia Warszawa Not yet recruiting
Warszawa, Poland, 00-660
ALL-MED Specjalistyczna Opieka Medyczna Not yet recruiting
Wroclaw, Poland, 50-445
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04092582     History of Changes
Other Study ID Numbers: GB41149
2019-000795-41 ( EudraCT Number )
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases