Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy (MG56)

NCT02654223 Phase 2 COMPLETED

The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy

Details

Lead sponsor	Inmunotek S.L.
Phase	Phase 2
Status	COMPLETED
Enrolment	180
Start date	2015-12-30
Completion	2021-11

Conditions

• Rhinitis
• Rhinoconjunctivitis

Interventions

• MG56 Mannosylated 500 subcutaneous
• MG56 Mannosylated 1000 subcutaneous
• MG56 Mannosylated 3000 subcutaneous
• MG56 Mannosylated 5000 subcutaneous
• MG56 Mannosylated 500 sublingual
• MG56 Mannosylated 1000 sublingual
• MG56 Mannosylated 3000 sublingual
• MG56 Mannosylated 5000 sublingual
• Subcutaneous placebo
• Sublingual placebo

Primary outcomes

• Concentration required to elicit a positive response after nasal provocation test (NPT) — 4 months
  Change in the threshold concentration of grass allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry. This will be compared between the beginning and end of the trial and among active groups and placebo.

Countries

Spain