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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier:
NCT01564017
First received: March 23, 2012
Last updated: January 11, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Allergic Rhinoconjunctivitis
Biological: Allergovac depot
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II, Multicenter, Randomized, Double-blind Study, With Subcutaneous Immunotherapy, in Parallel Groups and Placebo-controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Dermatophagoides Pteronyssinus.

Resource links provided by NLM:


Further study details as provided by BIAL Industrial Farmacéutica S.A.:

Primary Outcome Measures:
  • Changes in nasal provocation test [ Time Frame: from baseline (V0) to final visit (VF 18 weeks after randmization) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allergovac depot. Group 1
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

Depot sterile suspension fpor subcutaneous injection

Increasing concentrations to reach the following maintenance doses:

Group 1: 0.25 SPT

Experimental: Allergovac depot. Group 2
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

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 2: 0.5 SPT

Experimental: Allergovac depot. Group 3
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

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 3: 1 SPT

Experimental: Allergovac depot. Group 4
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

depot sterile suspension for subcutaneous injection

Increasing concentrations to reach the following maintenance doses:

Group 4: 2 SPT

Experimental: Allergovac depot. Group 5
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

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 5: 4 SPT

Placebo Comparator: Allergovac depot placebo. Group 6
The same scheme of treatment as the active groups
Biological: Allergovac depot

Sterile suspension for subcutaneous injection.

Same number of administration as the active groups


  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  4. Patients who have had a skin prick test result greater or equal to 3 mm in diameter against Dermatophagoides pteronyssinus.
  5. Patients who have specific Immunoglobulin E (IgE) greater or equal to class 2 (CAP/PHADIA) to Dermatophagoides pteronyssinus.
  6. 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.
  7. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
  8. Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.

Exclusion Criteria:

  1. Patients with stable and continued use of medication to treat their allergic condition during the 2 weeks prior to their inclusion in the study.
  2. 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.
  3. 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.
  4. 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.
  5. Patients with immunological, cardiac, renal or hepatic diseases or with any other illness which the investigators deem may interfere with the study.
  6. Patients with a prior history of anaphylaxis.
  7. Patients with chronic urticaria.
  8. Patients with moderate-severe atopic dermatitis.
  9. Patients with clinically relevant malformations of the upper respiratory tract.
  10. Patients who have participated in another clinical trial within 3 months prior to this study.
  11. Patients being treated with tricyclic antidepressants, psychotropic drugs, beta-blockers, or angiotensin-converting enzyme inhibitors (ACEIs).
  12. 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.
  13. Patients who cannot attend study visits.
  14. Patients who are uncooperative or refuse to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564017

Locations
Spain
Hospital Vega Baja
Orihuela, Alicante, Spain, 03314
Hospital Germans Triasl i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Donostia
Donostia-San Sebastián, Guipuzcoa, Spain, 20014
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Hospital Xeral de Vigo
Vigo, Pontevedra, Spain, 36024
Hospital de Manises
Manises, Valencia, Spain, 46940
Hospital Luis Alcañiz
Xátiva, Valencia, Spain, 46800
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Hospital Blanca Paloma
Huelva, Spain, 21005
Hospital Marqués de Valdecilla
Santander, Spain, 39008
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
BIAL Industrial Farmacéutica S.A.
Investigators
Principal Investigator: Fernando Rodríguez, MD Hospital Universitario Marqués de Valdecilla
Principal Investigator: Ramón Lleonart, MD Hospital Universitario Marqués de Valdecilla
Principal Investigator: Albert Roger, MD HOSPITAL GERMANS TRIAS I PUJOL
Principal Investigator: Dolores Hernández, MD Hospital Universitari i Politècnic 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
  More Information

No publications provided

Responsible Party: BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier: NCT01564017     History of Changes
Other Study ID Numbers: BIA--DPT-P2-001, 2011-004583-30
Study First Received: March 23, 2012
Last Updated: January 11, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by BIAL Industrial Farmacéutica S.A.:
Allergy
Allergic rhinoconjunctivitis
Immunotherapy
D. pteronyssinus
house dust allergy

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2014