Avanz Phleum Pratense Maintenance Dose

ALK-Abelló

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergic Rhinoconjunctivitis

Treatments: Drug: Placebo; Drug: Avanz Phleum pratense

Study type: Interventional

Funder types: Industry

Identifiers

NCT01438827

AV-G-02

Details and patient eligibility

About

The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.

Enrollment: 450 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A history of grass pollen allergy
• Positive skin prick test to grass
• Positive Immunoglobulin E test to grass

Exclusion criteria

• Other allergies overlapping the grass pollen season
• Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 3 patient groups, including a placebo group

Avanz Phleum pratense 15,000 SQ+

Active Comparator group

Treatment:

Drug: Avanz Phleum pratense

Avanz Phleum pratense 4,000 SQ+

Active Comparator group

Treatment:

Drug: Avanz Phleum pratense

Injection with no active grass component

Placebo Comparator group

Treatment:

Drug: Placebo