Comparison of Different Up-dosing Schedules With Osiris

ALK-Abelló

Status and phase: Terminated; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: OSIRIS other concentration 2; Drug: OSIRIS; Drug: OSIRIS other concentration 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01240954

OS-I-01

Details and patient eligibility

About

The purpose of this study is to compare different up-dosing schedules with Osiris.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of grass pollen allergy
• Positive SPT to grass
• Positive IgE to grass

Exclusion criteria

• uncontrolled and severe asthma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups

OSIRIS

Active Comparator group

Treatment:

Drug: OSIRIS

OSIRIS other concentration 1

Experimental group

Treatment:

Drug: OSIRIS other concentration 1

OSIRIS other concentration 2

Experimental group

Treatment:

Drug: OSIRIS other concentration 2