A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica

NCT ID: NCT02477917

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-03-31

Brief Summary

The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.

Detailed Description

Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas, reaching 41.4% among allergic patients on the Spanish Mediterranean coast.

The study has been designed as an open trial which will be conducted in 4 Spanish sites.

Conditions

Rhinoconjunctivitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allergovac depot

Allergovac depot with Parietaria judaica pollen extract

Group Type: EXPERIMENTAL

Allergovac depot with Parietaria judaica pollen extract

Intervention Type: 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

Interventions

Allergovac depot with Parietaria judaica pollen extract

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

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 seasonal allergic rhinoconjunctivitis against Parietaria judaica during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013).

4. Patients who obtained a prick test result ≥ 3 mm diameter to Parietaria judacia. Positive and negative control of the test should give consistent results.

5. Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Parietaria judaica.

6. Patients sensitized to Parietaria judaica with clinically relevant symptoms in which treatment with Parietaria judaica 100% vaccine is indicated.

7. Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.

8. Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.

Exclusion Criteria

1. Patients who received immunotherapy in the previous 5 years for Parietaria judaica or fo rany allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.

2. Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .

3. 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.

4. Patients with a previous history of anaphylaxis

5. Patients with chronic urticaria,

6. Patients with moderate to severe atopic dermatitis

7. Patients who have participated in another clinical trial within 3 month prior to enrolment.

8. Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)

9. Female patients who are pregnant or breast-feeding

10. Patient who does not attend the visits

11. Patient's lack of collaboration or refusal to participate.

• 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

Araitz Landeta

Role: STUDY_CHAIR

Roxall Medicina España S.A

Locations

Hospital Vega Baja

Orihuela, Alicante, Spain

Hospital de Manises

Manises, Valencia, Spain

Hosptal de Sagunto

Sagunto, Valencia, Spain

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Countries

Spain

Other Identifiers

BIA-PAR-DEPOT

Identifier Type: -

Identifier Source: org_study_id