Loading clinical trials...

COMPLETEDPHASE2

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

NCT02069535•ALK-Abelló A/S

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

Hospital Clinico Universitario San Carlos

Madrid, Madrid, Spain

Key Dates

Start Date

April 1, 2014

Primary Completion Date

November 1, 2014

Completion Date

November 1, 2014

Last Updated

January 6, 2015

Enrollment

ACTUAL participants

Conditions

Allergic Rhinoconjunctivitis

Interventions

AVANZ Cupressus

BIOLOGICAL

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

NCT06778213

Allergic Rhinoconjunctivitis

View study

COMPLETEDPHASE2

Study of BLU-808 in Allergic Rhinoconjunctivitis

NCT06922448

Allergic Rhinoconjunctivitis

View study

COMPLETEDPHASE2

Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction

NCT04502966

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

Study of BLU-808 in Allergic Rhinoconjunctivitis

Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis

Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy