Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy

Circassia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Ragweed Allergy

Treatments: Biological: Placebo; Biological: ToleroMune Ragweed

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01361412

TR002A

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in study TR002 but have not yet commenced dosing

Exclusion criteria

• None; no criteria additional to TR002 exclusion criteria are applicable to this study

Trial design

20 participants in 5 patient groups, including a placebo group

ToleroMune Ragweed 4

Experimental group

Treatment:

Biological: ToleroMune Ragweed

ToleroMune Ragweed Regimen 3

Experimental group

Treatment:

Biological: ToleroMune Ragweed

ToleroMune Ragweed Regimen 2

Experimental group

Treatment:

Biological: ToleroMune Ragweed

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo

ToleroMune Ragweed Regimen 1

Experimental group

Treatment:

Biological: ToleroMune Ragweed