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

NCT ID: NCT01564017

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Allergovac depot

Intervention Type: BIOLOGICAL

Depot sterile suspension fpor subcutaneous injection

Increasing concentrations to reach the following maintenance doses:

Group 1: 0.25 SPT

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.

Group Type: EXPERIMENTAL

Allergovac depot

Intervention Type: BIOLOGICAL

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 2: 0.5 SPT

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.

Group Type: EXPERIMENTAL

Allergovac depot

Intervention Type: BIOLOGICAL

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 3: 1 SPT

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.

Group Type: EXPERIMENTAL

Allergovac depot

Intervention Type: BIOLOGICAL

depot sterile suspension for subcutaneous injection

Increasing concentrations to reach the following maintenance doses:

Group 4: 2 SPT

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.

Group Type: EXPERIMENTAL

Allergovac depot

Intervention Type: BIOLOGICAL

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 5: 4 SPT

Allergovac depot placebo. Group 6

The same scheme of treatment as the active groups

Group Type: PLACEBO_COMPARATOR

Allergovac depot

Intervention Type: BIOLOGICAL

Sterile suspension for subcutaneous injection.

Same number of administration as the active groups

Interventions

Allergovac depot

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 2: 0.5 SPT

Intervention Type: BIOLOGICAL

Allergovac depot

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 3: 1 SPT

Intervention Type: BIOLOGICAL

Allergovac depot

depot sterile suspension for subcutaneous injection

Increasing concentrations to reach the following maintenance doses:

Group 4: 2 SPT

Intervention Type: BIOLOGICAL

Allergovac depot

Depot sterile suspension for subcutaneous injection.

Increasing concentrations to reach the following maintenance doses:

Group 5: 4 SPT

Intervention Type: BIOLOGICAL

Allergovac depot

Sterile suspension for subcutaneous injection.

Same number of administration as the active groups

Intervention Type: BIOLOGICAL

Allergovac depot

Depot sterile suspension fpor subcutaneous injection

Increasing concentrations to reach the following maintenance doses:

Group 1: 0.25 SPT

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roxall Medicina España S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Rodríguez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Marqués de Valdecilla

Ramón Lleonart, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Marqués de Valdecilla

Albert Roger, MD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Dolores Hernández, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Fe

Carmen Vidal, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Santiago

Juan A Pagán, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Arrixaca

Carmen Marcos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Xeral de Vigo

Jose A Navarro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Donostia

Victoria Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Blanca Paloma

Luis A Navarro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Luis Alcañiz

María I Peña, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vega Baja

Marta Alvariño, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Manises

Locations

Hospital Vega Baja

Orihuela, Alicante, Spain

Hospital Germans Triasl i Pujol

Badalona, Barcelona, Spain

Hospital Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Hospital Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Xeral de Vigo

Vigo, Pontevedra, Spain

Hospital de Manises

Manises, Valencia, Spain

Hospital Luis Alcañiz

Xátiva, Valencia, Spain

Hospital Universitari de Bellvitge

Barcelona, , Spain

Hospital Blanca Paloma

Huelva, , Spain

Hospital Marqués de Valdecilla

Santander, , Spain

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Countries

Spain

Other Identifiers

2011-004583-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIA--DPT-P2-001

Identifier Type: -

Identifier Source: org_study_id