A Study to Assess the Efficacy and Safety of MSTT1041A in Patients with Uncontrolled Severe Asthma

Phase 1

• Conditions: ncontrolled Severe Asthma; MedDRA version: 19.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000004855; MedDRA version: 19.0 Level: LLT Classification code 10015888 Term: Extrinsic asthma System Organ Class: 100000004855; MedDRA version: 19.0 Level: LLT Classification code 10003561 Term: Asthma, unspecified System Organ Class: 100000004855; MedDRA version: 19.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855; MedDRA version: 19.0 Level: LLT Classification code 10003554 Term: Asthma aggravated System Organ Class: 100000004855; MedDRA version: 19.0 Level: LLT Classification code 10068393 Term: Neutrophilic asthma System Organ Class: 100000004855; MedDRA version: 19.0 Level: LLT Classification code 10022847 Term: Intrinsic asthma System Organ Class: 100000004855; MedDRA version: 19.0 Level: LLT Classification code 10074614 Term: Nocturnal asthma System Organ Class: 100000004855; MedDRA version: 19.0 Level: LLT Classification code 10003638 Term: Atopic asthma System Organ Class: 100000004855

• Registration Number: EUCTR2016-001549-13-BE
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 501

Inclusion Criteria

- Age 18-75 years
- Body mass index (BMI) of 18-35 kg/square meter (kg/m2) and weight >= 40 kg at screening
- Documented physician-diagnosed asthma
- On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
- Forced expiratory volume in 1 second (FEV1) of 40%-80% of predicted
- Evidence of uncontrolled asthma
- Use of contraceptive measures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 401
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Diagnosis of mimics of asthma
- Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease overlap syndrome, or bronchiolitis, as determined by the investigator
- Pregnant or lactating, or intending to become pregnant during the study or within 20 weeks after the last dose of MSTT1041A
- Recent history of smoking
- History or evidence of substance abuse that would pose a risk to patient safety, interfere with the conduct of the study, have an impact on the study results
- Asthma exacerbation within 4 weeks prior to screening
- Intubation for respiratory failure due to asthma within 12 months prior to screening
- Comorbid conditions that may interfere with evaluation of investigational medicinal product
- Known sensitivity to any of the active substances or their excipients to be administered during dosing
- Positive pregnancy test
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the efficacy of MSTT1041A compared with placebo;<br> Secondary Objective: • To evaluate the safety and efficacy of MSTT1041A compared with placebo<br> • To evaluate the pharmacokinetics (PK) of MSTT1041A<br> • To evaluate the immune response to MSTT1041A<br> ;<br> Primary end point(s): Efficacy:<br> 1. Incidence of asthma exacerbations<br> ;Timepoint(s) of evaluation of this end point: 1. Week 54