An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069535
• Other study ID #: AV-X-03
• Secondary ID: 2013-004720-11
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2014
• Last updated: January 5, 2015
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

This trial is an open, national, multi-centre trial. The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement of related Adverse Events.

Description:

The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica, the measurement rate is the frequency of patients with investigational medicinal product (IMP)-related adverse events (AEs) will be the primary endpoint.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry.

• Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter = 3 mm)

Exclusion Criteria:

• History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.

• Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).

• Ongoing treatment with any allergen-specific immunotherapy product.

• A history of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction).

• A systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis, Allergic

Intervention

Biological:
• AVANZ Cupressus
AVANZ Cupressus

Locations

Country	Name	City	State
Spain	Hospital Clinico Universitario San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients with IMP-related AEs		6 treatment weeks	Yes
Secondary	Frequency of patients with systemic reactions		6 weeks of treatment	Yes