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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.

Study Description
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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

Study Design
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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

Arms and Interventions
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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.


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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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