Rhinoconjunctivitis Clinical Trial
Official title:
An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and
fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is
associated with poorer lung function, greater medication requirements and more asthma
symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there
is evidence that HDMA leads to the development of asthma, in addition to exacerbating
pre-existing asthma in HDM-sensitised patients.
ToleroMune HDM is currently being developed for the treatment of HDM allergy.
The Purpose of this optional observational follow-on study is to evaluate the continued
efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline
approximately two years after the completion of the baseline EEC visit in TH002 following
challenge with HDM allergen in an EEC.
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TH002 will be invited to attend the Screening visit for TH002a. Subjects will attend for 3 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later. ;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05560698 -
A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment
|
N/A | |
Completed |
NCT02849210 -
A Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea
|
Phase 1 | |
Completed |
NCT02150343 -
Phase II HDM-SPIRE Safety and Efficacy Study
|
Phase 2 | |
Completed |
NCT02340130 -
Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
|
Phase 2 | |
Completed |
NCT01949415 -
An Optional Investigation of Biomarkers of Efficacy
|
N/A | |
Completed |
NCT01949428 -
House Dust Mite Observational Study
|
N/A | |
Completed |
NCT01949441 -
ToleroMune House Dust Mite (HDM) Tolerability Study
|
Phase 2 | |
Completed |
NCT01447784 -
ToleroMune House Dust Mites (HDM) Exposure Chamber Study
|
Phase 2 | |
Recruiting |
NCT04435990 -
Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
|
Phase 3 | |
Active, not recruiting |
NCT05960266 -
Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study
|
Early Phase 1 | |
Completed |
NCT01720251 -
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
|
Phase 2 | |
Completed |
NCT01620762 -
Phase III Cat-PAD Study
|
Phase 3 | |
Completed |
NCT01448603 -
ToleroMune Ragweed Follow up Study
|
N/A | |
Completed |
NCT01353755 -
2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma
|
Phase 3 | |
Completed |
NCT00537342 -
Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
|
Phase 3 | |
Completed |
NCT00540631 -
Multicenter Trial of Immunotherapy With House Dust Mite Allergoid
|
Phase 3 | |
Completed |
NCT00574210 -
PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)
|
Phase 2 | |
Completed |
NCT05540717 -
Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen
|
Phase 3 | |
Completed |
NCT02844842 -
Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice
|
||
Completed |
NCT01734265 -
Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).
|
Phase 2 |