Dose-Finding Study Clinical Trial
Official title:
A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma
Specific immunotherapy for IgE mediated sensitization to grass pollen
4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the
optimum dose.
This is a dose finding study and no therapeutic study. Patients will receive in 4-weekly
intervals 6x 0,5mL of one of 4 different concentrations of Depigoid Phleum. The study is
performed outside the pollen season. Thus the aim of the study is not the therapeutic effect
of the specific immunotherapy (effect on allergy specific symptoms during the pollen season)
but the effect on the Conjunctival provocation test (CPT). According to the EMA "Guideline
on clinical development of products for specific immunotherapy for the treatment of allergic
diseases" provocation tests are accepted as primary outcomes for dose-finding studies.
For the CPT increasing doses of Phleum pollen solutions are applied to the eye and
characteristic symptoms (eye redness, weeping, itching or burning, and nose
dripping/blockage) are assessed at each concentration: 0=absent, 1=mild, 2=moderate,
3=severe. At a score value of >=5/concentration the test is considered positive and
finished.
It is expected that at the end of the study higher doses are necessary to provoke a positive
CPT.
Furthermore comparative evaluation of the safety data (AEs) in the different dosage groups
is a very important parameter for the evaluation of the outcome of the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02201056 -
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
|
Phase 1 |