An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

ALK-Abelló

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergic Rhinoconjunctivitis

Treatments: Drug: AVANZ Phleum pratense

Study type: Interventional

Funder types: Industry

Identifiers

NCT01454531

AV-G-01

Details and patient eligibility

About

The purpose of this study is to assess the tolerability of AVANZ.

Full description

To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.

Enrollment: 199 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of grass pollen rhinoconjunctivitis
• Positive SPT to Phleum pratense
• Positive specific IgE against Phleum pratense

Exclusion criteria

• Uncontrolled severe asthma

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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199 participants in 1 patient group

AVANZ Phleum pratense

Experimental group

Description:

AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

Treatment:

Drug: AVANZ Phleum pratense