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

Phase 2

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Biological: AVANZ Cupressus

• Registration Number: NCT02069535
• Lead Sponsor: ALK-Abelló A/S

Brief 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.

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 Timeline

• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-24
• Study Start: 2014-04
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-05
• Last Update Posted: 2015-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AVANZ Cupressus	AVANZ Cupressus	AVANZ Cupressus

Primary Outcome Measures

Name	Time	Method
Frequency of patients with IMP-related AEs	6 treatment weeks

Secondary Outcome Measures

Name	Time	Method
Frequency of patients with systemic reactions	6 weeks of treatment

Trial Locations

Locations (1)

Hospital Clinico Universitario San Carlos; 🇪🇸 Madrid, Spain