Safety and Tolerance Study of Grass Pollen-derived Peptides to Treat Allergic Rhinitis

Preliminary Assessment of the Short Term Clinical Tolerability and Safety 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 to treat allergic rhinitis is safe and well tolerated.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Hospital University Ghent

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:

• 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 females
• A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the last two years
• A positive skin prick test 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 for SAR
• 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 food allergy and consecutive anaphylaxis
• Subjects with a history of hepatic or renal disease
• 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).
• Females unable to bear children must have documentation of such (i.e. tubal ligation, hysterectomy, or post menopausal [defined as a minimum of one year since the last menstrual period])
• 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 with clinically relevant abnormal QTc intervals of the ECG : QTc > 450 ms for man and > 470 ms for women
• Subjects requiring beta-blockers medication
• Chronic use of concomitant medications that would affect assessment of the effectiveness of the study 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 study entry
• Receipt of blood or a blood derivative in the past 6 months preceding study entry
• Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the study, any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the study
• 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,
• Participation in another clinical trial and/or treatment with an experimental drug within 1 month of study start
• A history of hypersensitivity to the excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gpASIT+TM	Biological: gpASIT+TM; oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction.	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
vital signs clinical laboratory evaluations adverse events general physical status	10 days

Collaborators and Investigators

• Sponsor: BioTech Tools S.A.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (Estimate): December 22, 2008

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 23, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctivitis; Conjunctival Diseases; Conjunctivitis, Allergic
• Other Study ID Numbers: BTT-gpASIT002; EudraCT 2008-006368-12