drugset / Trial / NCT04898283
Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.
Timeline
- Start
- 2021-05-31
- Primary completion
- 2026-10
- Completion
- 2026-10
Publications
- 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.
- Background Caballero R, Grau A, Javaloyes G, Del Pozo S, Leon MA, Romero M, Casanovas M. Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal. Int Arch Allergy Immunol. 2021;182(7):571-573. doi: 10.1159/000513543. Epub 2021 Jan 26. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MG01 | Protein / enzyme biologic | 10000 unknown | Subcutaneous |
| Subject | MG01 | Protein / enzyme biologic | 30000 unknown | Subcutaneous |
| Subject | T521 | Unknown | 10000 unknown | Subcutaneous |