CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 517 enrolled
Drug / intervention
MSTT1041A +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02918019
NCT02918019Phase 2Completed

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Uncontrolled Severe Asthma

Hoffmann-La Roche·interventional·Posted Sep 28, 2016·Updated Dec 28, 2022

In Brief

A Phase 2 clinical trial evaluating MSTT1041A and Placebo for Asthma. Completed, enrolled 517 participants across 138 sites in 15 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Belgium, Bulgaria, Canada, Czechia, Germany, New Zealand, Peru, Poland, Romania, Russia, South Africa, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 28, 2016
Enrollment StartSep 20, 2016
Primary CompletionApr 5, 2019
Study CompletionJul 26, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.8 years ago

Interventions

MSTT1041Adrug

MSTT1041A will be administered as subcutaneous injections.

Placebodrug

Placebo matched with MSTT1041A.