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

A

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)

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

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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