NCT01198613

Brief Summary

It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy. This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

September 6, 2010

Last Update Submit

October 6, 2011

Conditions

Ragweed Allergy

Keywords

Ragweed allergyRhinoconjunctivitisExposure chamberImmunotherapyToleroMune Ragweed

Outcome Measures

Primary Outcomes (1)

  • Total Rhinoconjunctivitis Symptom Score

    Upto 22 weeks

Secondary Outcomes (7)

  • Symptom scores for ocular and nasal symptoms

    Upto 22 weeks

  • Acoustic Rhinometry

    Upto 22 weeks

  • Skin prick testing

    Baseline and final follow up

  • Ragweed specific IgE

    At baseline and at follow up

  • Ragweed specific IgA

    At baseline and follow up

  • +2 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Biological: Placebo

ToleroMune Ragweed Regimen 1

EXPERIMENTAL
Biological: ToleroMune Ragweed

ToleroMune Ragweed Regimen 2

EXPERIMENTAL
Biological: ToleroMune Ragweed

ToleroMune Ragweed Regimen 3

EXPERIMENTAL
Biological: ToleroMune Ragweed

ToleroMune Ragweed Regimen 4

EXPERIMENTAL
Biological: ToleroMune Ragweed

Interventions

ToleroMune RagweedBIOLOGICAL

Intradermal injection 1 x8 administrations 2 weeks apart

ToleroMune Ragweed Regimen 1ToleroMune Ragweed Regimen 2ToleroMune Ragweed Regimen 3ToleroMune Ragweed Regimen 4
PlaceboBIOLOGICAL

Intradermal injection, 1x8 administrations 2 weeks apart

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 18-65 years.
  • Minimum 2-year documented history of rhinoconjunctivitis on exposure to ragweed. \[Subjects may also have controlled asthma
  • Positive skin prick test to ragweed allergen.
  • Minimum qualifying rhinoconjunctivitis symptom scores

You may not qualify if:

  • History of asthma.
  • A history of anaphylaxis to ragweed allergen.
  • Subjects with an FEV1 \<70% of predicted.
  • Subjects who cannot tolerate baseline challenge in the EEC.
  • Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
  • A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
  • A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KGK Synergize Inc.

London, Ontario, ON N6A 5R8, Canada

Location

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Location

Study Officials

  • Deepen Patel, MD, CCFP

    Cetero Research, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2010

First Posted

September 10, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

CA(2)