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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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04092582
Collaborator
(none)
135
Enrollment
36
Locations
2
Arms
30.6
Actual Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
135 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 :
Oct 31, 2019
Actual Primary Completion Date :
May 19, 2022
Actual Study Completion Date :
May 19, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Time to First CompEx Event [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 [From randomization visit [Week 2] to end of treatment [Week 50]]

  2. Time to First Asthma Exacerbation [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) [From randomization visit [Week 2] to end of treatment [Week 50]]

  4. Absolute and Relative Change in Fractional Exhaled Nitric Oxide (FeNO) [Randomization [Week 2] to end of treatment [Week 50]]

  5. Percentage of Participants With Adverse Events [Up to approximately Week 58]

  6. Serum Concentration of MTPS9579A [Weeks 2, 3, 6, 10, 14, 22, 30, 38, 50, 54]

  7. Percentage of Participants with Anti-Drug Antibodies (ADAs) [Up to Week 54]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kern Research Bakersfield California United States 93301
2 Allergy & Asthma Medical Group of the Bay Area Walnut Creek California United States 94598
3 IMMUNOe Research Centers Centennial Colorado United States 80112
4 Winchester Chest Clinic New Haven Connecticut United States 06510
5 Florida Ctr-Allergy & Asthma Miami Florida United States 33173
6 Florida Pulmonary Research Institute, LLC Winter Park Florida United States 32789
7 Nebraska Medical Research Institute, Inc. - CRN Bellevue Nebraska United States 68123
8 Toledo Inst of Clin Research Toledo Ohio United States 43617
9 OK Clinical Research Edmond Oklahoma United States 73034
10 Temple University Hospital Philadelphia Pennsylvania United States 19140
11 Spartanburg Medical Research Spartanburg South Carolina United States 29303
12 Metroplex Pulmonology & Sleep Center McKinney Texas United States 75069
13 Fundacion Cidea Buenos Aires Argentina C1121ABE
14 Centro Médico Dra. Cristina de Salvo Buenos Aires Argentina C1426ABO
15 CARE - Centro de Alergia y Enfermedades Respiratorias Caba Argentina C1414AIF
16 INSARES Mendoza, Mendoza City Argentina M5500CCG
17 Centro Respiratorio Quilmes Quilmes Argentina B1878FNR
18 Research Center for Medical Studies RCMS Berlin Germany 10717
19 IKF Pneumologie Frankfurt am Main Germany 60596
20 Pneumologicum Hannover Germany 30173
21 BAG Prof Dr G Hoheisel Dr A Bonitz Leipzig Germany 04275
22 SMO.MD GmbH, Zentrum für klinische Studien Magdeburg Germany 39120
23 Helix Medical Excellence Center Mainz Mainz Germany 55128
24 Hospital Chancay y Servicios Basicos de Salud Huaral Peru 15131
25 Clinica Providencia (Inverconsult Sociedad Anonima) Lima Peru 32
26 Clinica Internacional Lima Peru Lima 1
27 Clinica Ricardo Palma; THORAX Lima Peru Lima 27
28 Centrum Medycyny Oddechowej Robert M. Mróz Bialystok Poland 15-003
29 Centrum Medyczne ALL-MED Krakow Poland 30-033
30 Malopolskie Centrum Alergologii Krakow Poland 31-624
31 Centrum Opieki Zdrowotnej Orkan-Med Ksawerow Poland 95-054
32 SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Lodz Poland 90-153
33 Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik Ostrowiec Swietokrzysk Poland 27-400
34 Centrum Alergologii Teresa Hofman Poznan Poland 60-214
35 PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna Sosnowiec Poland 41-200
36 ALL-MED Specjalistyczna Opieka Medyczna Wroclaw Poland 50-445

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT04092582
Other Study ID Numbers:
  • GB41149
  • 2019-000795-41
First Posted:
Sep 17, 2019
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Asthma

Study Results

No Results Posted as of May 26, 2022