NCT01361412

Brief Summary

The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

May 24, 2011

Last Update Submit

October 6, 2011

Conditions

Ragweed Allergy

Keywords

ragweed allergyimmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Identification of potential plasma biomarkers of response to peptide immunotherapy

    Blood samples derived from the study will be submitted for proteomics analyses aimed at the identification of one or more plasma proteins whose concentration over the course of the study varies in relation to the treatment administered. The outcome will be determined on the basis of measurements from samples collected over a period commencing prior to treatment and ending 6 months following treatmen

    6 months after start of dosing

Study Arms (5)

ToleroMune Ragweed 4

EXPERIMENTAL
Biological: ToleroMune Ragweed

ToleroMune Ragweed Regimen 3

EXPERIMENTAL
Biological: ToleroMune Ragweed

ToleroMune Ragweed Regimen 2

EXPERIMENTAL
Biological: ToleroMune Ragweed

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

ToleroMune Ragweed Regimen 1

EXPERIMENTAL
Biological: ToleroMune Ragweed

Interventions

ToleroMune RagweedBIOLOGICAL

Intradermal administration 1x8 administrations, 2 weeks apart

ToleroMune Ragweed 4ToleroMune Ragweed Regimen 1ToleroMune Ragweed Regimen 2ToleroMune Ragweed Regimen 3
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:

  • Enrolled in study TR002 but have not yet commenced dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 26, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

CA(1)