drugset / Trial / NCT03688074
Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE)
RandomizedParallel-groupTriple-blindTreatment
Summary
A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.
Timeline
- Start
- 2018-11-02
- Primary completion
- 2020-11-16
- Completion
- 2020-11-16
Outcome
Mixed primary results
paper nominally significantly greater reduction from baseline to the end of treatment in airway submucosal eosinophils versus placebo PMID 34256031 ↗
registry Teze 210 mg Q4W vs Placebo; p <0.001; Ratio of Geometric LSMeans 0.15 (90% CI 0.06 to 0.35) NCT03688074 ↗
paper There were no significant differences between treatment groups in the other cell types evaluated PMID 34256031 ↗
Publications
- Nordenmark LH, Hellqvist A, Emson C, Diver S, Porsbjerg C, Griffiths JM, Newell JD, Peterson S, Pawlikowska B, Parnes JR, Megally A, Colice G, Brightling CE. Tezepelumab and Mucus Plugs in Patients with Moderate-to-Severe Asthma. NEJM Evid. 2023 Oct;2(10):EVIDoa2300135. doi: 10.1056/EVIDoa2300135. Epub 2023 Sep 20.
- Pham TH, Chen C, Colice G, Parnes JR, Griffiths JM, Cook B. Tezepelumab normalizes serum interleukin-5 and -13 levels in patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2021 Dec;127(6):689-691. doi: 10.1016/j.anai.2021.08.008. Epub 2021 Aug 14. No abstract available.
- Diver S, Khalfaoui L, Emson C, Wenzel SE, Menzies-Gow A, Wechsler ME, Johnston J, Molfino N, Parnes JR, Megally A, Colice G, Brightling CE; CASCADE study investigators. Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Respir Med. 2021 Nov;9(11):1299-1312. doi: 10.1016/S2213-2600(21)00226-5. Epub 2021 Jul 10.
- Emson C, Diver S, Chachi L, Megally A, Small C, Downie J, Parnes JR, Bowen K, Colice G, Brightling CE. CASCADE: a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of tezepelumab on airway inflammation in patients with uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):265. doi: 10.1186/s12931-020-01513-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tezepelumab | Monoclonal antibody | 210 mg | Subcutaneous |