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An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber

NCT00537355 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2019-04-16

No results posted yet for this study

Summary

This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85).

During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points.

The total duration of a subject's participation in this study is expected to be a minimum of 85 days.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

BIOLOGICAL

Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate

6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg)

DRUG

Histamine

6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg)

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Eduardo Martins, MD, DPhil · Dynavax Technologies Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-03-31
Completion
2008-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537355 on ClinicalTrials.gov