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

• Sponsor: Roxall Medicina España S.A (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02477917
• Collaborator: (none)
• Enrollment: 51
• Locations: 4
• Arm: 1
• Duration (Months): 10
• Patients Per Site: 12.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinoconjunctivitis	Biological: Allergovac depot with Parietaria judaica pollen extract	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Allergovac depot Allergovac depot with Parietaria judaica pollen extract	Biological: 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

Outcome Measures

Primary Outcome Measures

1. Number and severity of adverse reactions as a measure of Safety and tolerability [across 17 weeks treatment period]

Secondary Outcome Measures

1. Immunoglobulin changes from baseline [At baseline and 1 week after last administered dose]

2. Skin reactivity changes from baseline [At baseline and 1 week after last administered dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Vega Baja	Orihuela	Alicante	Spain	03314
2	Hospital de Manises	Manises	Valencia	Spain
3	Hosptal de Sagunto	Sagunto	Valencia	Spain	46520
4	Hospital Universitario y Politécnico La Fe	Valencia		Spain	46026

Sponsors and Collaborators

• Roxall Medicina España S.A

Investigators

• Study Chair: Araitz Landeta, Roxall Medicina España S.A

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roxall Medicina España S.A
• ClinicalTrials.gov Identifier: NCT02477917
• Other Study ID Numbers: BIA-PAR-DEPOT
• First Posted: Jun 23, 2015
• Last Update Posted: May 1, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Roxall Medicina España S.A: allergy; SCIT
• Additional relevant MeSH terms: Conjunctivitis

Study Results

No Results Posted as of May 1, 2017