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Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House Dust Mites

Primary Purpose

Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Allergovac depot DPT/DF (50:50)
Sponsored by
Roxall Medicina España S.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must sign the informed consent form
  2. Patients must be between 18 and 60 years of age
  3. Patients with perennial allergic rhinoconjunctivitis against HDM during a minimum of 1 year prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2015)
  4. Patients who obtained a prick test result ≥ 3 mm diameter to HDM. Positive and negative control of the test should give consistent results
  5. Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to HDM
  6. Patients sensitized to HDM with clinically relevant symptoms in which treatment with HDM (50:50) vaccine is indicated
  7. Women of childbearing potential must have a negative urine pregnancy test at visit 1
  8. Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active

Exclusion Criteria:

  1. Patients who received immunotherapy in the previous 5 years for HDM or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen
  2. Patients with severe asthma or forced expiratory volume in 1 second FEV1 < 70% even if the are pharmacologically controlled
  3. Polysensitized patients besides other airborne allergens Dermatophagoides pteronyssinus and Dermatophagoides farinae, which according to the investigator may present clinically relevant to those other airborne allergens while participating in this study
  4. Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study
  5. Patients with a previous history of anaphylaxis
  6. Patients with active chronic urticaria
  7. Patients with active severe atopic eczema
  8. Patients who have participated in another clinical trial within 3 month prior to enrollment
  9. Patients under treatment with tricyclic antidepressives, phenothiazines, β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
  10. Female patients who are pregnant or breast-feeding
  11. Patient who does not attend the visits
  12. Patient's lack of collaboration or refusal to participate

Sites / Locations

  • Hospital Germans Triasl i Pujol
  • Hospital de Bellvitge
  • Hospital de Basurto
  • Hospital de Valdecilla
  • Hospital Universitario de Araba

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allergovac depot with HDM extract

Arm Description

Extract of mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (50:50) adsorbed onto aluminum hydroxide 0.33%.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

Secondary Outcome Measures

Immunoglobulin level changes
Skin prick test reactivity

Full Information

First Posted
July 29, 2016
Last Updated
October 19, 2017
Sponsor
Roxall Medicina España S.A
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1. Study Identification

Unique Protocol Identification Number
NCT02881879
Brief Title
Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House Dust Mites
Official Title
An Open, Multicenter Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxall Medicina España S.A

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity. It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5 participating spanish sites. Primary endpoint of the study is to assess the safety and tolerability of subcutaneous immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis with or without mild asthma sensitized to house dust mites Secondary objective is to evaluate the indirect immunotherapy efficacy through the measurement of immunoglobulin level changes and cutaneous reactivity
Detailed Description
The aim of present clinical trial is to go deeper into the safety of the vaccine of mixture of DPT and DF (50:50). Although this is the first clinical trial to date to be performed with this vaccine, there have been two clinical trials with the same formulation and DPT 100% as active ingredient( NºEudraCT: 2009-016277-15 and NºEudraCT: 2011-004583-30). Given that there is a remarkable cross-reactivity between the DPT and DF mites, the results of the two clinical trials conducted to date with subcutaneous depot vaccine with Dermatophagoides pteronyssinus 100% extract mite, are very significant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allergovac depot with HDM extract
Arm Type
Experimental
Arm Description
Extract of mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (50:50) adsorbed onto aluminum hydroxide 0.33%.
Intervention Type
Biological
Intervention Name(s)
Allergovac depot DPT/DF (50:50)
Intervention Description
Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Time Frame
From date inform consent is signed until the date the treatment is completed, assessed up to 5 months
Secondary Outcome Measure Information:
Title
Immunoglobulin level changes
Time Frame
Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)
Title
Skin prick test reactivity
Time Frame
Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must sign the informed consent form Patients must be between 18 and 60 years of age Patients with perennial allergic rhinoconjunctivitis against HDM during a minimum of 1 year prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2015) Patients who obtained a prick test result ≥ 3 mm diameter to HDM. Positive and negative control of the test should give consistent results Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to HDM Patients sensitized to HDM with clinically relevant symptoms in which treatment with HDM (50:50) vaccine is indicated Women of childbearing potential must have a negative urine pregnancy test at visit 1 Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active Exclusion Criteria: Patients who received immunotherapy in the previous 5 years for HDM or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen Patients with severe asthma or forced expiratory volume in 1 second FEV1 < 70% even if the are pharmacologically controlled Polysensitized patients besides other airborne allergens Dermatophagoides pteronyssinus and Dermatophagoides farinae, which according to the investigator may present clinically relevant to those other airborne allergens while participating in this study Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study Patients with a previous history of anaphylaxis Patients with active chronic urticaria Patients with active severe atopic eczema Patients who have participated in another clinical trial within 3 month prior to enrollment Patients under treatment with tricyclic antidepressives, phenothiazines, β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI) Female patients who are pregnant or breast-feeding Patient who does not attend the visits Patient's lack of collaboration or refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araitz Landeta
Organizational Affiliation
Roxall Medicina España S.A
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Germans Triasl i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
Country
Spain
Facility Name
Hospital de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Universitario de Araba
City
Vitoria
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House Dust Mites

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