Skip to main content
OpenTrials
Completed

NCT Number: NCT01448603

ToleroMune Ragweed Follow up Study

Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2%

The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing visits and the post treatment challenge (PTC) visit in study TR002 approximately one year after the start of treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ragweed Allergy Rhinoconjunctivitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

About this study

Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4 visits on successive days. Following the final EEC visit a follow-up visit will be performed 3-10 days later.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously randomised into study TR002 and completed all treatment visits and the PTC.

Exclusion criteria

  • History of asthma (a diagnosis of asthma in childhood may be allowed).
  • Subjects with an FEV1 <70% of predicted.
  • Subjects being treated with beta-blockers.
  • Developed a significant disease, disorder or inability to communicate, since completing study TR002 which, in the opinion of the Sponsor's medical representative, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.

Treatment and study plan

Placebo

Biological

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

ToleroMune Ragweed

Biological

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

Primary outcomes

  1. Total Rhinoconjunctivitis Symptom Score

    Time frame: 48-54 weeks after the start of treatment in TR002

Secondary outcomes

  1. Total nasal and non-nasal symptom scores

    Time frame: 48-54 weeks after the start of treatment in TR002

  2. Change in Immunoglobulin A (IgA)

    Time frame: 50-56 weeks after the start of treatment in Tr002

  3. Change in Immunoglobulin E (IgE)

    Time frame: 50-56 weeks after the start of treatment in Tr002

  4. Change in Immunoglobulin G4 (IgG4)

    Time frame: 50-56 weeks after the start of treatment in Tr002

  5. Adverse Events

    Time frame: 50-56 weeks after the start of treatment in TR002

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.
  • Cetero Research, San Antonio

Registry information

Official study title

An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2011
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.