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

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• MSTT1041A — DRUG
  MSTT1041A will be administered as subcutaneous injections.
• Placebo — DRUG
  Placebo matched with MSTT1041A.

Study Details

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.

Key Dates

First listed

Sep 28, 2016

Start date

Sep 20, 2016

Status verified

Nov 2022

Primary completion

Apr 5, 2019

Completion

Jul 26, 2019

Study Design

Enrollment

517 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MSTT1041A 210 mg
  Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
• Experimental: MSTT1041A 490 mg
  Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
• Experimental: MSTT1041A 70 mg
  Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
• Placebo Comparator: Placebo
  Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.

Primary Outcome Measure

Reduction in Rate of Asthma Exacerbations [ Time Frame: Baseline to Week 54 ]

Locations (43)

Find similar trials in Birmingham, AL

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