Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis

NCT ID: NCT01111279

Last Updated: 2011-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-11-30

Brief Summary

The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients.

Conditions

Seasonal Allergic Rhinoconjunctivitis

Study Design

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

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo solution

Intervention Type: BIOLOGICAL

1 subcutaneous injection every 7 days, during 29 days

gpASIT+TM

Group Type: EXPERIMENTAL

gpASIT+TM

Intervention Type: BIOLOGICAL

1 subcutaneous injection every 7 days, during 29 days.

gpASIT+TM/adjuvant

Group Type: EXPERIMENTAL

gpAST+TM/adjuvant

Intervention Type: BIOLOGICAL

1 subcutaneous injection every 7 days, during 29 days

Interventions

gpASIT+TM

1 subcutaneous injection every 7 days, during 29 days.

Intervention Type: BIOLOGICAL

gpAST+TM/adjuvant

1 subcutaneous injection every 7 days, during 29 days

Intervention Type: BIOLOGICAL

Placebo solution

1 subcutaneous injection every 7 days, during 29 days

Intervention Type: BIOLOGICAL

Eligibility Criteria

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
• Females 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 diagnosis:

• A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least during 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 even if shown to be hypersensitive in a skin prick test.

Exclusion Criteria

• Subjects with current or past immunotherapy (any time in the past)
• A history of hypersensitivity to the excipients
• Subjects requiring control medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
• Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
• Subjects with a history of hepatic or renal disease
• Subjects symptomatic to perennial inhalant allergens
• Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
• Subject with malignant disease, autoimmune disease (and family medical history of autoimmune disease)
• 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
• Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD)
• 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
• Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
• Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start
• Subjects who participated to trial BTT-gpASIT003 and were in the treated groups

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioTech Tools S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

BioTech Tools

Principal Investigators

Jan Ceuppens, Professor

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven, Gasthuisberg

Leuven, , Belgium

Countries

Belgium

Other Identifiers

BTT-gpASIT004

Identifier Type: -

Identifier Source: org_study_id