A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
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.
Timeline
- Start
- 2016-09-20
- Primary completion
- 2019-04-05
- Completion
- 2019-07-26
Outcome
Met primary endpoint
registry analysis (other test); Astegolimab (MSTT1041A) 490mg; p = 0.0049; Rate Ratio 0.57 (95% CI 0.39 to 0.84); Poisson regression NCT02918019 ↗
registry analysis (other test); Astegolimab (MSTT1041A) 70mg; p = 0.0144; Rate Ratio 0.63 (95% CI 0.44 to 0.91); Poisson regression NCT02918019 ↗
Publications
- Yin Z, Zhou Y, Turnquist HR, Liu Q. Neuro-epithelial-ILC2 crosstalk in barrier tissues. Trends Immunol. 2022 Nov;43(11):901-916. doi: 10.1016/j.it.2022.09.006. Epub 2022 Oct 14.
- Kelsen SG, Agache IO, Soong W, Israel E, Chupp GL, Cheung DS, Theess W, Yang X, Staton TL, Choy DF, Fong A, Dash A, Dolton M, Pappu R, Brightling CE. Astegolimab (anti-ST2) efficacy and safety in adults with severe asthma: A randomized clinical trial. J Allergy Clin Immunol. 2021 Sep;148(3):790-798. doi: 10.1016/j.jaci.2021.03.044. Epub 2021 Apr 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Astegolimab | Monoclonal antibody | 70 mg | Subcutaneous |
| Subject | Astegolimab | Monoclonal antibody | 210 mg | Subcutaneous |
| Subject | Astegolimab | Monoclonal antibody | 490 mg | Subcutaneous |