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

NCT01567306 | Completed Phase 2 Results

• 2 other identifiers: BIA-PHL-P2-0012011-000814-21
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 10

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.

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergy; Allergic rhinoconjunctivitis; Subcutaneous Immunotherapy; Phleum pratense pollen extract

Outcome Measures

Primary Outcomes (1)

• Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).

  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).

  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.

Secondary Outcomes (1)

• 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.

  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

Study Arms (6)

Allergovac Depot Group 1 Active

EXPERIMENTAL

Biological: Allergovac Depot

Allergovac Depot Group 2 Active

EXPERIMENTAL

Biological: Allergovac Depot

Allergovac Depot Group 3 Active

EXPERIMENTAL

Biological: Allergovac Depot

Allergovac Depot Group 4 Active

EXPERIMENTAL

Biological: Allergovac Depot

Allergovac Depot Group 5 Active

EXPERIMENTAL

Biological: Allergovac Depot

Placebo - Group 6

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Allergovac Depot BIOLOGICAL

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

Also known as: Allergovac

Allergovac Depot Group 1 Active

Placebo BIOLOGICAL

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

Also known as: Allergovac

Placebo - Group 6

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 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.
• Patients who have had a skin prick test result equal or more than 3 mm in diameter against Phleum pratense.
• Patients who have specific IgE equal or more than class 2 (CAP/PHADIA) to Phleum pratense.
• 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.
• Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
• Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.

You may not qualify if:

• 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.
• 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.
• 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.
• Patients with immunological, cardiac, renal or hepatic diseases or any with any other illness which the investigators deem may interfere with the study.
• Patients with a prior history of anaphylaxis.
• Patients with chronic urticaria.
• Patients with moderate-severe atopic dermatitis.
• Patients with clinically relevant malformations of the upper respiratory tract.
• Patients who have participated in another clinical trial within 3 months prior to this study.
• Patients being treated with tricyclic antidepressants, psychotropic drugs, beta-blockers, or angiotensin-converting enzyme inhibitors (ACEIs).
• 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.
• Patients who cannot attend study visits.
• Patients who are uncooperative or refuse to participate in the study.

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (10)

Hospital da Universidade de Coimbra

Coimbra, 3000-075, Portugal

Location

Centro Hospitalar de S. João

Porto, 4200-319, Portugal

Location

Instituto CUF Porto

Senhora da Hora, 4460-188, Portugal

Location

Centro Hospitalar de Setúbal - Hospital de São Bernardo

Setúbal, 2910-446, Portugal

Location

Centro Hospitalar Gaia/Espinho

Vila Nova de Gaia, 4434-502, Portugal

Location

Hospital Ntra. Sra. del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Limitations and Caveats

The small simple size, the strong placebo effect and patients without a positive result with any of the tested vials at the final visit were assigned the vial 4 value for analysis purposes, meaning no real improvement could be observed in patients.

Results Point of Contact

• Title: Dr. M Cruz Gómez project manager of Roxall Medicina España S.A.
• Organization: Roxall Medicina España S.A.

maricruz.gomez@roxall.es

+34 944438000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 30, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-01

Locations

ES (5); PT (5)