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

NCT02881879 | Completed Phase 1

• 1 other identifier: BIA-HDMD-101
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 5

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

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  From date inform consent is signed until the date the treatment is completed, assessed up to 5 months

Secondary Outcomes (2)

• Immunoglobulin level changes

  Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)

• Skin prick test reactivity

  Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)

Study Arms (1)

Allergovac depot with HDM extract

EXPERIMENTAL

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

Biological: Allergovac depot DPT/DF (50:50)

Interventions

Allergovac depot DPT/DF (50:50) BIOLOGICAL

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

Allergovac depot with HDM extract

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must sign the informed consent form
• Patients must be between 18 and 60 years of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (5)

Hospital Germans Triasl i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital de Valdecilla

Santander, Spain

Location

Hospital Universitario de Araba

Vitoria-Gasteiz, Spain

Location

Study Officials

• Araitz Landeta

  Roxall Medicina España S.A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 29, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)