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

• ClinicalTrials.gov Identifier: NCT01564017
• Recruitment Status: Completed
• First Posted: March 27, 2012
• Last Update Posted: May 1, 2017
• Sponsor: Roxall Medicina España S.A
• Information provided by (Responsible Party): Roxall Medicina España S.A

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Allergic Rhinoconjunctivitis	Biological: Allergovac depot	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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.
• Study Start Date: May 2012
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Changes in nasal provocation test [ Time Frame: from baseline (V0) to final visit (VF 18 weeks after randmization) ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

Roxall Medicina España 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; 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

More Information

• Responsible Party: Roxall Medicina España S.A
• ClinicalTrials.gov Identifier: NCT01564017
• Other Study ID Numbers: BIA--DPT-P2-001; 2011-004583-30 ( EudraCT Number )
• First Posted: March 27, 2012
• Last Update Posted: May 1, 2017
• Last Verified: April 2017

Keywords provided by Roxall Medicina España S.A:

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

Additional relevant MeSH terms:

Conjunctivitis; Conjunctival Diseases; Eye Diseases