ToleroMune House Dust Mite Follow on Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01923792
Study type	Observational
Source	Circassia Limited
Contact
Status	Completed
Phase	N/A
Start date	September 2013
Completion date	April 2014

View Details

See also
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	`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	`NCT00537342` - Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)	Phase 3
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