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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis
• Intervention / Treatment: Biological: AVANZ Cupressus

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Clínico Universitario San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVANZ Cupressus	Biological: AVANZ Cupressus; AVANZ Cupressus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of patients with IMP-related AEs	6 treatment weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of patients with systemic reactions	6 weeks of treatment

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Investigators: Study Chair: Montserrat Fernández Rivas, PhD, Hospital Clínico Universitario San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 24, 2014

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Cupressus arizonica
• Other Study ID Numbers: AV-X-03; 2013-004720-11 (EudraCT Number)