Clinical efficacy, immunogenicity, clinical tolerability and assessment of safety of gpASIT+TM administered orally, according to two administration schedules, for the prophylaxis of seasonal grass pollen rhinoconjunctivitis - Not available

Phase 1

• Conditions: Treatment of seasonal grass pollen rhinoconjunctivitis; MedDRA version: 12.1Level: LLTClassification code 10019170Term: Hay fever

• Registration Number: EUCTR2010-023176-12-BE
• Lead Sponsor: Biotech Tools sa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-21
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 414

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:
oA medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years
oA positive skin prick test (wheal diameter = 3 mm) to grass-pollen mixture
oSpecific IgE against grass pollen (IgE > 0.7 kU/l)
oAsymptomatic to perennial inhalant allergens
•Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2008 and who had moderate to severe symptoms during the last two years
•Subjects with seasonal asthma are allowed to be included

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subjects with current immunotherapy and subjects who underwent an immunotherapy within the last 2 years
•Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years
•A history of hypersensitivity to the excipients
•Subjects with perennial asthma.
•Subjects requiring control medication against asthma from step 2 according to GINA classification (ref. is made to Appendix 5)
•Subjects with an VC < 80% and a FEV1 < 70% of predicted value
•Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
•Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
•Subjects symptomatic to perennial inhalant allergens
•Subjects with a history of hepatic or renal disease
•Subject with malignant disease, 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 ulcer, inflammatory bowel disease, 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)
•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
•Subject with febrile illness (> 37.5°C, oral)
•A known positive serology for HIV-1/2, HBV or HCV
•Subjects that are immunocompromised by medication or illness, have 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
•Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (i.e. OCs, IUD, V-rings and contraceptive implants)
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this clinical trial is to assess the effect of a 28-day treatment with 2 different doses of gpASIT+TM compared with placebo on the reduction of the rhinoconjunctivitis scores and use of rescue medication in adults suffering from moderate to severe grass pollen allergic rhinitis rhinoconjunctivitis.;Secondary Objective: The secondary objectives of the trial are<br>•To assess the impact of gpASIT+TM on the immunological status of the subjects in comparison with placebo,<br>•To assess the safety and clinical tolerability of gpASIT+TM.<br>;Primary end point(s): Primary endpoint: <br>•The primary endpoint is the reduction of rhinoconjunctivitis total symptom scores (RTSS) in the treated groups in comparison with the placebo group.<br>