BTT-gpASIT008

Summary

ASIT+TM products are based on allergen fragments with optimal size distribution obtained from natural sources. The gpASIT+TM active principle consist in a very broad panel of epitopes covering all the allergens present in the current immunotherapy products while having a reduced risk of induction of systemic allergic reactions.

The primary objective of this clinical trial is to assess the therapeutic effect of 3 gpASIT+TM regimens administered by subcutaneous injections in patients suffering from hay fever. The effect is to be assessed by means of the reactivity to a conjunctival provocation test (CPT) for actively treated patients in comparison to placebo regimen.

The secondary objectives are:
– To assess the impact of gpASIT+TM on the immunological status of the subjects in comparison with placebo,
– To assess the safety and clinical tolerability of gpASIT+TM.

Immunological parameters of the patients and mechanism of action of gpASIT+TM was studied in collaboration with Dr. M. Shamji of the Imperial College London.

Lay Summary

Respiratory allergies have a significant impact on the patients, their family and on the society in general. These affect multiple parameters including quality of life, physical, psychological and social functioning and has important financial consequences. Although there are differences among countries, the incidence and prevalence of respiratory allergies is increasing worldwide. In Europe, the overall prevalence of patients with allergic rhinitis is 23%, while in the United States it is estimated at 22%.

ASIT biotech’s strategy is to develop products to satisfy unmet medical needs, so the target population of gpASIT+TM are those suffering from moderatetosevere allergic rhinitis. The fact that one third of the patients suffering from moderatesevere allergic rhinitis also have asthma will improve the medicoeconomic impact of gpASIT+TM.

ASIT biotech S.A.

A prospective, randomized, double-blind placebo-controlled multi-centre dose-finding study of 3 different regimens of gpASIT+TM administered subcutaneously to adult patients with grass pollen-induced allergic rhinoconjunctivitis.

Principal Investigator(s)

  • Clinic : Ralph Mosges
  • Mechanistic: Mohamed Shamji

Type of Study

Randomized, double-blind placebo-controlled multi-centre phase iib study. trial is registered on clinicaltrialsregister.eu with number 2013-005445-37

Dates

23rd May 2014

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