Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis

Preliminary Assessment of the Clinical Tolerability, Safety and Immunogenicity of Three Different Doses of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis

The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinoconjunctivitis
• Intervention / Treatment: Biological: Placebo; Biological: gpASIT+TM; Biological: gpASIT+TM; Biological: gpASIT+TM

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • University Hospital Brugmann
  • Ghent, Belgium, 9000
    • University Hospital Ghent
  • Leuven, Belgium, 3000
    • University Hospital Gasthuisberg
  • Liège, Belgium, 4000
    • University Hospital Sart Tilman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has given written informed consent
• Age between 18 and 50 years
• The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
• Male or non pregnant, non-lactating female
• Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
• Allergy:

A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years A positive skin prick test (wheal diameter >= 3 mm) to grass-pollen mixture Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l) Asymptomatic to perennial inhalant allergens.

Exclusion Criteria:

• Subjects with current or past immunotherapy (any time in the past)
• Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
• Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)
• Subjects with a history of hepatic or renal disease
• Subjects symptomatic to perennial inhalant allergens
• Subject with malignant disease, autoimmune disease
• Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD)
• Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…)
• Subjects requiring beta-blockers medication
• Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
• Subject with febrile illness (> 37.5°C, oral)
• A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
• The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
• Receipt of blood or a blood derivative in the past 6 months preceding trial entry
• Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
• Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
• Use of long-acting antihistamines
• Any condition which could be incompatible with protocol understanding and compliance
• Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
• Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
• Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start
• A history of hypersensitivity to the excipients
• Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
• Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
• Subjects who participated to trial BTT-gpASIT002

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Biological: Placebo; placebo entero-coated capsules
EXPERIMENTAL: gpASIT 25	Biological: gpASIT+TM; entero-coated capsules containing 25µg of gpASIT+TM; Biological: gpASIT+TM; entero-coated capsules containing 100µg of gpASIT+TM; Biological: gpASIT+TM; entero-coated capsules containing 400µg of gpASIT+TM
EXPERIMENTAL: gpASIT 100	Biological: gpASIT+TM; entero-coated capsules containing 25µg of gpASIT+TM; Biological: gpASIT+TM; entero-coated capsules containing 100µg of gpASIT+TM; Biological: gpASIT+TM; entero-coated capsules containing 400µg of gpASIT+TM
EXPERIMENTAL: gpASIT 400	Biological: gpASIT+TM; entero-coated capsules containing 25µg of gpASIT+TM; Biological: gpASIT+TM; entero-coated capsules containing 100µg of gpASIT+TM; Biological: gpASIT+TM; entero-coated capsules containing 400µg of gpASIT+TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evidence of allergic reaction	within the first 14 days (plus or minus 1 day)

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunological assessment	9 months
Allergy symptom and medication scores	grass pollen season 2009

Collaborators and Investigators

• Sponsor: BioTech Tools S.A.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: January 29, 2009
• First Posted (ESTIMATE): January 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2011
• Last Update Submitted That Met QC Criteria: November 16, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: grass pollen allergy; hay fever
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: BTT-gpASIT003; EudraCT 2008-006369-10