Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

NCT ID: NCT01567306

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-04-30

Brief Summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine.

Detailed Description

In adherence to EMA guidelines, the Phase I Clinical trial was carried out using Phleum pratense extract in depot presentation using 3 different dose escalation scheme. The objective was to compare tolerance and safety of the three dose escalation scheme as well as to determine the maximum dose tolerated by the population.

Once the range of tolerated doses was established, and following the strict norms of the EMA, a Phase II dose response clinical trial was designed wherein the efficacy of subcutaneous immunotherapy in depot presentation could be compared in 5 different doses. One of these doses will be the MTD established by the population in the first study, another will be lower than this dose, and three will be greater than it. The dose escalation scheme to be tested was chosen based on the results of the aforementioned clinical trial. As dictated by EMA norms, a control placebo will be used.

Conditions

Allergic Rhinoconjunctivitis

Study Design

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

Study Groups

Allergovac Depot Group 1 Active

Group Type: EXPERIMENTAL

Allergovac Depot

Intervention Type: BIOLOGICAL

Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Allergovac Depot Group 2 Active

Group Type: EXPERIMENTAL

Allergovac Depot

Intervention Type: BIOLOGICAL

Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Allergovac Depot Group 3 Active

Group Type: EXPERIMENTAL

Allergovac Depot

Intervention Type: BIOLOGICAL

Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Allergovac Depot Group 4 Active

Group Type: EXPERIMENTAL

Allergovac Depot

Intervention Type: BIOLOGICAL

Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Allergovac Depot Group 5 Active

Group Type: EXPERIMENTAL

Allergovac Depot

Intervention Type: BIOLOGICAL

Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Placebo - Group 6

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Interventions

Allergovac Depot

Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

Placebo

Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

Other Intervention Names

Allergovac; Allergovac; Allergovac; Allergovac; Allergovac; Allergovac

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 produced by Phleum pratense 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 equal or more than 3 mm in diameter against Phleum pratense.

5. Patients who have specific IgE equal or more than class 2 (CAP/PHADIA) to Phleum pratense.

6. Patients will preferably be monosensitized to Phleum pratense. Polysensitized patients may only be included in the study if their other sensitizations are produced by:

• Overlapping seasonal pollens which are cross-reactive with Phleum pratense.
• Pollens whose seasons do not overlap with Phleum pratense and which are not expected to produce symptoms during the study period.
• Other allergens which are not expected 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 allergy medication during the 2 weeks prior to their inclusion in the study.

2. Patients sensitized to allergens with overlapping seasons but which are not cross-reactive with Phleum pratense and with specific IgE levels equal or less than class 2 CAP/PHADIA.

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 any 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

Emilio Alvarez Cuesta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal

Santiago Quirce, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Matilde Rodríguez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta de Hierro

José Manuel Zubeldia, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Gregorio Marañón

Carmen Panizo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Ntra. Sra. del Prado

João Fonseca, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto CUF Porto

José Luís Plácido, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar de S. João

José Alberto Ferreira, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Gaia/Espinho

Celso Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital da Universidade de Coimbra

Filipe Inácio, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar de Setúbal - Hospital de São Bernardo

Locations

Hospital da Universidade de Coimbra

Coimbra, , Portugal

Centro Hospitalar de S. João

Porto, , Portugal

Instituto CUF Porto

Senhora da Hora, , Portugal

Centro Hospitalar de Setúbal - Hospital de São Bernardo

Setúbal, , Portugal

Centro Hospitalar Gaia/Espinho

Vila Nova de Gaia, , Portugal

Hospital Ntra. Sra. del Prado

Talavera de la Reina, Toledo, Spain

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Countries

Portugal; Spain

Other Identifiers

2011-000814-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIA-PHL-P2-001

Identifier Type: -

Identifier Source: org_study_id