Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma (AMETHYST)

Allergopharma

Status and phase: Completed; Phase 3

Conditions: Rhinoconjunctivitis

Treatments: Biological: Placebo; Biological: AL0704rP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00671268

2007-003208-37 (EudraCT Number)

AL0704rP

Details and patient eligibility

About

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Enrollment: 256 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Allergic rhinoconjunctivitis attributable to grass pollen
• Positive SPT
• Positive EAST
• Positive provocation test

Exclusion criteria

• serious disease
• other perennial allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

strict subcutaneous

Treatment:

Biological: AL0704rP

2

Placebo Comparator group

Description:

strict subcutaneous

Treatment:

Biological: Placebo