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

NCT02477917 | Completed Phase 1

• 1 other identifier: BIA-PAR-DEPOT
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

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.

Conditions

Rhinoconjunctivitis

Keywords

allergy; SCIT

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse reactions as a measure of Safety and tolerability

  across 17 weeks treatment period

Secondary Outcomes (2)

• Immunoglobulin changes from baseline

  At baseline and 1 week after last administered dose

• Skin reactivity changes from baseline

  At baseline and 1 week after last administered dose

Study Arms (1)

Allergovac depot

EXPERIMENTAL

Allergovac depot with Parietaria judaica pollen extract

Biological: Allergovac depot with Parietaria judaica pollen extract

Interventions

Allergovac depot with Parietaria judaica pollen extract 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

Allergovac depot

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 who obtained a prick test result ≥ 3 mm diameter to Parietaria judacia. Positive and negative control of the test should give consistent results.
• Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Parietaria judaica.
• Patients sensitized to Parietaria judaica with clinically relevant symptoms in which treatment with Parietaria judaica 100% vaccine is indicated.
• Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.
• Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.

You may not qualify if:

• 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.
• Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1\< 70% even if the are pharmacologically controlled .
• 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.
• Patients with a previous history of anaphylaxis
• Patients with chronic urticaria,
• Patients with moderate to severe atopic dermatitis
• Patients who have participated in another clinical trial within 3 month prior to enrolment.
• Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
• Female patients who are pregnant or breast-feeding
• Patient who does not attend the visits
• Patient's lack of collaboration or refusal to participate.

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (4)

Hospital Vega Baja

Orihuela, Alicante, 03314, Spain

Location

Hospital de Manises

Manises, Valencia, Spain

Location

Hosptal de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Parietaria judaica pollen

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Araitz Landeta

  Roxall Medicina España S.A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 23, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

ES (4)