Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract

NCT01564017 | Completed Phase 2

• 2 other identifiers: BIA--DPT-P2-0012011-004583-30
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 12

Brief Summary

As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergy; Allergic rhinoconjunctivitis; Immunotherapy; D. pteronyssinus; house dust allergy

Outcome Measures

Primary Outcomes (1)

• Changes in nasal provocation test

  Variation of the concentration of DPT extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).

  from baseline (V0) to final visit (VF 18 weeks after randmization)

Study Arms (6)

Allergovac depot. Group 1

EXPERIMENTAL

Increasing dosages till the maintenance dose of 0.0625 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Biological: Allergovac depot

Allergovac depot. Group 2

EXPERIMENTAL

Increasing dosages till the maintenance dose of 0.125 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Biological: Allergovac depot

Allergovac depot. Group 3

EXPERIMENTAL

Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Biological: Allergovac depot

Allergovac depot. Group 4

EXPERIMENTAL

Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Biological: Allergovac depot

Allergovac depot. Group 5

EXPERIMENTAL

Increasing dosages till the maintenance dose of 0.75 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Biological: Allergovac depot

Allergovac depot placebo. Group 6

PLACEBO COMPARATOR

The same scheme of treatment as the active groups

Biological: Allergovac depot

Interventions

Allergovac depot BIOLOGICAL

Depot sterile suspension fpor subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 1: 0.25 SPT

Allergovac depot. Group 1

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 with perennial allergic rhinoconjunctivitis produced by Dermatophagoides pteronyssinus during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
• Patients who have had a skin prick test result greater or equal to 3 mm in diameter against Dermatophagoides pteronyssinus.
• Patients who have specific Immunoglobulin E (IgE) greater or equal to class 2 (CAP/PHADIA) to Dermatophagoides pteronyssinus.
• Patients will preferably be monosensitized to Dermatophagoides pteronyssinus. Polysensitized patients may only be included in the study if their other sensitizations are produced by:
• Pollens whose season period does not overlap with the study treatment or, if overlap, whose specific IgE levels are less than class 2.
• Perennial allergens with specific IgE levels less than class 2.
• Allergens that do not cohabit with the patient or whose environmental levels are not high enough to produce symptoms during the study period.
• Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
• Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.

You may not qualify if:

• Patients sensitized and with specific IgE levels greater or equal to class 2 to other perennial or seasonal allergens clinically relevant including other mites unless they are cross reactive with Dermatophagoides pteronyssinus.
• Patients who have received immunotherapy in the 5 years prior to the study against either the allergen being tested or an allergen which is cross-reactive, or who are currently receiving immunotherapy for any other allergen.
• Patients with severe asthma or FEV1\< 70% or with asthma which requires treatment with inhaled or systemic corticoids at the time of the study or in the 8 weeks immediately prior to the onset of treatment.
• Patients with immunological, cardiac, renal or hepatic diseases or with any other illness which the investigators deem may interfere with the study.
• Patients with a prior history of anaphylaxis.
• Patients with chronic urticaria.
• Patients with moderate-severe atopic dermatitis.
• Patients with clinically relevant malformations of the upper respiratory tract.
• Patients who have participated in another clinical trial within 3 months prior to this study.
• Patients being treated with tricyclic antidepressants, psychotropic drugs, beta-blockers, or angiotensin-converting enzyme inhibitors (ACEIs).
• Women who are pregnant or breast-feeding or are of child-bearing age and who do not agree to use adequate contraception if they are sexually active and who have not demonstrated that they have been surgically sterilized or have other means of not bearing children.
• Patients who cannot attend study visits.
• Patients who are uncooperative or refuse to participate in the study.

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (12)

Hospital Vega Baja

Orihuela, Alicante, 03314, Spain

Location

Hospital Germans Triasl i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Donostia

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Xeral de Vigo

Vigo, Pontevedra, 36024, Spain

Location

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Hospital Luis Alcañiz

Xátiva, Valencia, 46800, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Blanca Paloma

Huelva, 21005, Spain

Location

Hospital Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Fernando Rodríguez, MD

  Hospital Universitario Marqués de Valdecilla

  PRINCIPAL INVESTIGATOR

• Ramón Lleonart, MD

  Hospital Universitario Marqués de Valdecilla

  PRINCIPAL INVESTIGATOR

• Albert Roger, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Dolores Hernández, MD

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

• Carmen Vidal, MD

  Complejo Hospitalario Universitario de Santiago

  PRINCIPAL INVESTIGATOR

• Juan A Pagán, MD

  Hospital Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

• Carmen Marcos, MD

  Hospital Xeral de Vigo

  PRINCIPAL INVESTIGATOR

• Jose A Navarro, MD

  Hospital Donostia

  PRINCIPAL INVESTIGATOR

• Victoria Moreno, MD

  Hospital Blanca Paloma

  PRINCIPAL INVESTIGATOR

• Luis A Navarro, MD

  Hospital Luis Alcañiz

  PRINCIPAL INVESTIGATOR

• María I Peña, MD

  Hospital Vega Baja

  PRINCIPAL INVESTIGATOR

• Marta Alvariño, MD

  Hospital de Manises

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

ES (12)