Clinical Trials Logo
  1. Home
  2. Rhinoconjunctivitis
  3. NCT01949415
  4. Details
NCT01949415 Clinical Trial

An Optional Investigation of Biomarkers of Efficacy

Rhinoconjunctivitis Clinical Trial

Official title:
An Optional Investigation of Biomarkers of Efficacy in TH002 Clinical Study Subjects.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01949415
Other study ID # RES-008
Secondary ID
Status Completed
Phase N/A
First received September 20, 2013
Last updated May 20, 2014
Start date September 2013
Est. completion date April 2014

Study information
Verified date May 2014
Source Circassia Limited
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA 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 House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy.

Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002 study participants

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- Previously randomised into study TH002, completed the study and received either placebo or the 12 nmol dose in TH002.

Exclusion Criteria:

- Subjects who have received allergen or peptide immunotherapy during the last 12 months (other than TM-HDM)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Topstone Research Toronto Ontario

Sponsors (3)
Lead Sponsor Collaborator
Circassia Limited Adiga Life Sciences, Inc., Topstone Research

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary To identify cellular, proteomic or genetic biomarkers of efficacy to ToleroMune House Dust Mite (TM-HDM) treatment in TH002 study participants. 1 Day No
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 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 NCT02150343 - Phase II HDM-SPIRE Safety and Efficacy Study Phase 2
Completed NCT01949428 - House Dust Mite Observational Study N/A
Completed NCT01949441 - ToleroMune House Dust Mite (HDM) Tolerability Study Phase 2
Completed NCT01923792 - ToleroMune House Dust Mite Follow on Study N/A
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 NCT01620762 - Phase III Cat-PAD Study Phase 3
Completed NCT01720251 - Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy Phase 2
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 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 NCT00540631 - Multicenter Trial of Immunotherapy With House Dust Mite Allergoid 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