Safety of gpASIT+TM Subcutaneously Administered to Hay Fever Patients With or Without Immunoregulating Adjuvant

NCT01506375 | Completed Phase 2

• 2 other identifiers: gpASIT0062011-004486-33
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the safety, clinical tolerability, immunogenicity and efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating adjuvant, in a short course administration (5 injections over 4 weeks).

Conditions

Hay Fever

Keywords

seasonal allergic rhinoconjunctivitis; grass pollen; allergen specific immunotherapy

Outcome Measures

Primary Outcomes (2)

• Safety of the treatment

  Safety will be evaluated by the following parameters: general physical status, vital signs, haematological parameters, general biochemical parameters, solicited local adverse events, all (serious) adverse events, immunological analysis (total IgG and IgE), inflammatory parameters (CRP) and anti-adjuvant mmunoglobulins.

  up to the end of the grass pollen season

• Clinical tolerability of the treatment

  The clinical tolerability will by assessed through the solicited local adverse events, all (serious) adverse events and the investigator and subject opinion.

  Duration of treatment period (4 weeks)

Secondary Outcomes (3)

• Impact of gpASIT+TM with or without adjuvant on the immunological status of the subjects.

  up to 1 year after the start of treatment

• Impact of gpASIT+TM with or without adjuvant on the grass pollen allergic symptoms of the subjects.

  During the pollen season

• Long-term follow-up of the patients

  1 year after the start of treatment

Study Arms (2)

gpASIT

EXPERIMENTAL

grass pollen peptides alone

Biological: gpASIT+TM

gpASIT/adjuvant

EXPERIMENTAL

grass pollen peptides + adjuvant

Biological: gpASIT+TM + adjuvant

Interventions

gpASIT+TM BIOLOGICAL

1 subcutaneous injection every 7 days during 29 days

gpASIT

gpASIT+TM + adjuvant BIOLOGICAL

1 subcutaneous injection every 7 days during 29 days

gpASIT/adjuvant

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 medical history of moderate to severe 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 (IgE \> 0.7 kU/l) \[using recombinant mixture of rPhl p1 and rPhl p5b Phleum pratense (g213)\]
• Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2009 and who had as well moderate to severe symptoms in the two previous years (2010 and 2011)

You may not qualify if:

• Subjects with current immunotherapy and subjects who underwent a previous immunotherapy within the last 2 years
• Participation in another clinical trial and/or treatment with an experimental drug within the last 3 months
• A history of hypersensitivity to the excipients of investigational products
• Subjects with perennial asthma (regular intake of inhaled corticosteroids outside the pollen season: consumption on a daily base or patients who are taking a reliever more than twice a week)
• Subjects with severe seasonal asthma requiring long acting beta agonist AND inhaled steroid treatment
• Subjects with a VC \< 80% and a FEV1 \< 70% of predicted value at the screening visit
• Subjects symptomatic to perennial inhalant allergens who should need antihistamine drug or systemic corticoids to relieve allergic symptoms during the treatment period
• Subjects with documented evidence of chronic sinusitis (as determined by Investigator)
• Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
• Subjects with a history of renal disease or chronic hepatic disease
• Subject with malignant disease, autoimmune disease
• Any chronic disease, which may impair the subject's ability to participate in the trial
• 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)
• Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial (screening visit)

Sponsors & Collaborators

• BioTech Tools S.A.: lead

Study Sites (1)

Universitaire Ziekenhuis van Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Design

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

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: January 10, 2012
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 26, 2014

Record last verified: 2012-08

Locations

BE (1)