A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma

Roche

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: MSTT1041A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02918019

2016-001549-13 (EudraCT Number)

GB39242

Details and patient eligibility

About

This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The total duration of this study for each participant is approximately 70 weeks including screening, run-in, treatment, and follow-up.

Enrollment: 517 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) of 18 to 38 kilogram/square meter (kg/m^2) 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% to 80% of predicted
• Evidence of uncontrolled asthma
• Use of contraceptive measures

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 participants 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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517 participants in 4 patient groups, including a placebo group

MSTT1041A 210 mg

Experimental group

Description:

Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.

Treatment:

Drug: MSTT1041A

MSTT1041A 490 mg

Experimental group

Description:

Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.

Treatment:

Drug: MSTT1041A

MSTT1041A 70 mg

Experimental group

Description:

Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.

Treatment:

Drug: MSTT1041A

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.

Treatment:

Drug: Placebo