drugset / Trial / NCT04891237
Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive
Timeline
- Start
- 2021-06-14
- Primary completion
- 2026-01
- Completion
- 2027-01
Publications
- Background Subiza J, Feliu A, Subiza JL, Uhlig J, Fernandez-Caldas E. Cluster immunotherapy with a glutaraldehyde-modified mixture of grasses results in an improvement in specific nasal provocation tests in less than 2.5 months of treatment. Clin Exp Allergy. 2008 Jun;38(6):987-94. doi: 10.1111/j.1365-2222.2008.02995.x. Epub 2008 Apr 25.
- Background Klimek L, Uhlig J, Mosges R, Rettig K, Pfaar O. A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol. Allergy. 2014 Dec;69(12):1629-38. doi: 10.1111/all.12513. Epub 2014 Oct 6.
- Background Guzman-Fulgencio M, Caballero R, Lara B, Mena M, Tejera M, Sastre A, Subiza JL, Fernandez-Caldas E, Casanovas M. Safety of immunotherapy with glutaraldehyde modified allergen extracts in children and adults. Allergol Immunopathol (Madr). 2017 Mar-Apr;45(2):198-207. doi: 10.1016/j.aller.2016.08.008. Epub 2016 Dec 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MG01 | Protein / enzyme biologic | 10000 unknown | Subcutaneous |
| Subject | MG01 | Protein / enzyme biologic | 30000 unknown | Subcutaneous |
| Subject | T517 | Protein / enzyme biologic | 10000 unknown | Subcutaneous |