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

NCT01111279 | Completed Phase 1

• 1 other identifier: BTT-gpASIT004
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Clinical tolerability and safety of the treatment

  The following parameters will be assessed : general physical status, vital signs, haematological parameters , general blood biochemistry parameters, all (serious) adverse, immunological analysis (total IgG, total IgE) and inflammatory parameters (CRP, sedimentation rate)

  3 times during the treatment phase, at week 24 (the end of the study)

Secondary Outcomes (2)

• Impact of gpASIT+TM on the immunological status of the subjects

  visit 1, week 7, week 18 and week 24

• Impact of gpASIT+TM on the clinical status of the subjects

  1 May - 15 August 2010

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Biological: Placebo solution

gpASIT+TM

EXPERIMENTAL

Biological: gpASIT+TM

gpASIT+TM/adjuvant

EXPERIMENTAL

Biological: gpAST+TM/adjuvant

Interventions

gpASIT+TM BIOLOGICAL

1 subcutaneous injection every 7 days, during 29 days.

gpASIT+TM

gpAST+TM/adjuvant BIOLOGICAL

1 subcutaneous injection every 7 days, during 29 days

gpASIT+TM/adjuvant

Placebo solution BIOLOGICAL

1 subcutaneous injection every 7 days, during 29 days

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BioTech Tools S.A.: lead

Study Sites (1)

UZ Leuven, Gasthuisberg

Leuven, 3000, Belgium

Location

Study Officials

• Jan Ceuppens, Professor

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 27, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 1, 2011

Record last verified: 2011-02

Locations

BE (1)