A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Grass Pollen Allergy

Treatments: Drug: Grazax; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00773240

GT-18

Details and patient eligibility

About

The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis

Enrollment: 276 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive skin prick test to Phleum pratense
• Positive IgE to Phleum pratense
• signed informed consent
• A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms

Exclusion criteria

• No uncontrolled asthma in the past 12 months
• No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
• No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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276 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Grazax

Treatment:

Drug: Grazax

2

Placebo Comparator group

Treatment:

Drug: placebo