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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier:
NCT01567306
First received: March 23, 2012
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Allergic Rhinoconjunctivitis
Biological: Allergovac Depot
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Multicenter, Randomized, Double Blind Study, With Subcutaneous Immunotherapy At Different Doses, in Parallel Groups and Placebo-Controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Phleum Pratense

Resource links provided by NLM:


Further study details as provided by BIAL Industrial Farmacéutica S.A.:

Primary Outcome Measures:
  • Variation of the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). [ Time Frame: Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense. ] [ Designated as safety issue: No ]
    Variation of the concentration of Phleum pratense 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).


Secondary Outcome Measures:
  • All adverse reactions and or events will be recorded both by the patient and the health care personnel responsible for the administration of the subcutaneous immunotherapy. [ Time Frame: From baseline (V0) to final visit (VF). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. All AE should be monitored until they are satisfactorily resolved or stabilized after the final visit of the study ] [ Designated as safety issue: Yes ]
    The incidence and intensity of adverse events will be compared among the treatment groups.


Estimated Enrollment: 151
Study Start Date: October 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allergovac Depot Group 1 Active Biological: Allergovac Depot
Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Other Name: Allergovac
Experimental: Allergovac Depot Group 2 Active 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.
Other Name: Allergovac
Experimental: Allergovac Depot Group 3 Active Biological: Allergovac Depot
Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Other Name: Allergovac
Experimental: Allergovac Depot Group 4 Active Biological: Allergovac Depot
Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Other Name: Allergovac
Experimental: Allergovac Depot Group 5 Active Biological: Allergovac Depot
Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Other Name: Allergovac
Placebo Comparator: Placebo - Group 6 Biological: Placebo
Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Other Name: Allergovac

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567306

Locations
Portugal
Hospital da Universidade de Coimbra
Coimbra, Portugal, 3000-075
Centro Hospitalar de S. João
Porto, Portugal, 4200-319
Instituto CUF Porto
Senhora da Hora, Portugal, 4460-188
Centro Hospitalar de Setúbal - Hospital de São Bernardo
Setúbal, Portugal, 2910-446
Centro Hospitalar Gaia/Espinho
Vila Nova de Gaia, Portugal, 4434-502
Spain
Hospital Ntra. Sra. del Prado
Talavera de la Reina, Toledo, Spain, 45600
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28222
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
BIAL Industrial Farmacéutica S.A.
Investigators
Principal Investigator: Emilio Alvarez Cuesta, MD Hospital Universitario Ramón y Cajal
Principal Investigator: Santiago Quirce, MD Hospital Universitario La Paz
Principal Investigator: Matilde Rodríguez, MD Hospital Universitario Puerta de Hierro
Principal Investigator: José Manuel Zubeldia, MD Hospital Universitario Gregorio Marañón
Principal Investigator: Carmen Panizo, MD Hospital Ntra. Sra. del Prado
Principal Investigator: João Fonseca, MD Instituto CUF Porto
Principal Investigator: José Luís Plácido, MD Centro Hospitalar de S. João
Principal Investigator: José Alberto Ferreira, MD Centro Hospitalar Gaia/Espinho
Principal Investigator: Celso Pereira, MD Hospital da Universidade de Coimbra
Principal Investigator: Filipe Inácio, MD Centro Hospitalar de Setúbal - Hospital de São Bernardo
  More Information

No publications provided

Responsible Party: BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier: NCT01567306     History of Changes
Other Study ID Numbers: BIA-PHL-P2-001, 2011-000814-21
Study First Received: March 23, 2012
Last Updated: February 14, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Portugal: National Pharmacy and Medicines Institute

Keywords provided by BIAL Industrial Farmacéutica S.A.:
Allergy
Allergic rhinoconjunctivitis
Subcutaneous Immunotherapy
Phleum pratense pollen extract

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014