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

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: LLTClassification code 10003560Term: Asthma NOSSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-000795-41-PL
• Lead Sponsor: Genentech Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-26
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

- Ability to comply with the study protocol, in the investigator's judgment
- Age 18-75 years
- Body mass index of 18-38 kg/m2 and weight >= 40 kg at screening
- Documented physician-diagnosed asthma
- Pre-bronchodilator FEV1 40%-80% predicted at screening
- On inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
- Documented history of >= 2 asthma exacerbations within the 12
months prior to screening while on daily ICS maintenance therapy
- 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 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

- Diagnosis of mimics of asthma or significant respiratory disease other than asthma
- Recent history of smoking
- Pregnant, lactating, or intending to become pregnant during the study or within 60 days after the last dose of the investigational medical product
- Comorbid conditions that may interfere with the evaluation of an investigational medical product
- Known sensitivity to any of the active substances or their excipients to be administered during dosing
- History or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
- Asthma exacerbation within 4 weeks prior to screening
The above information is not intended to contain all considerations relevant to a patient’s participation in this clinical trial.

Study & Design

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