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

NCT00537355 | Completed Phase 2

• 1 other identifier: DV1-SAR-11
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

ragweed; ragweed allergy; allergy; allergies; allergic; seasonal allergic rhinitis; allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Total Nasal Symptom Score (TNSS)

  3 months

Secondary Outcomes (3)

• Total Non-Nasal Symptom Score (TNNSS)

  3 months

• Total Symptom Score (TSS)

  3 months

• quality of life questionnaire

  3 months

Study Arms (2)

TOLAMBA™

ACTIVE COMPARATOR

Biological: Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate

Histamine

SHAM COMPARATOR

Histamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator.

Drug: Histamine

Interventions

Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate BIOLOGICAL

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

Also known as: TOLAMBA™

TOLAMBA™

Histamine DRUG

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

Also known as: Histatrol

Histamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is willing and able to give signed informed consent, and must have provided this consent.
• Has a clinical history of seasonal allergic rhinitis with seasonal nasal allergy symptoms during each of the last 2 ragweed allergy seasons.
• Has documentation of a positive skin test to ragweed allergen within 12 months of screening.
• Has minimum qualifying symptom scores at the last visit of the Pre-Treatment EEC sessions (Visit 5, Day 4).
• If female of childbearing potential, is not pregnant and is consistently using an acceptable birth control method.
• Is normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.

You may not qualify if:

• A woman who is pregnant, breastfeeding, or planning a pregnancy.
• Has a history of more than mild asthma that requires the use of a daily inhaled or oral corticosteroid, leukotriene inhibitor, or cromolyn; or a daily inhaled short or long acting β-agonist.
• Has had any hospital admissions for asthma, a recent (within the past 12 months)asthma exacerbation that required either oral or inhaled corticosteroids, or a prior history of unstable asthma.
• Has received immunotherapy within the last 2 years that has contained ragweed pollen extract.
• Has previously participated in a clinical trial with TOLAMBA or another ragweed-based immunotherapy.
• Has received immunotherapy for any allergens within 30 days prior to Visit 1.
• Has the need for use of antihistamines or corticosteroids on a regular basis (systemic or topical).
• Has received anti-immunoglobulin E (IgE) antibody (Xolair®) within the past 12 months.
• Is currently taking monoamine oxidase (MAO) inhibitors.
• Has taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within 4 weeks prior to Visit 1.
• Has taken any antihistamine within 7 days prior to Visit 1 skin testing.
• Requires use of β-adrenergic blockers or other agents that may interfere with the use of adrenaline.
• Known current alcohol or drug abuse.
• Current participation in another clinical study involving an investigational drug or device, or participation in such a study within 30 days prior to Visit 1.
• Has a history of generalized anaphylaxis requiring medical attention.

Sponsors & Collaborators

• Dynavax Technologies Corporation: lead

Study Sites (6)

Allied Research International Inc.

Mississauga, Ontario, L4W 1N2, Canada

Location

Alpha Medical Research Inc.

Mississauga, Ontario, L5A 3V4, Canada

Location

Allergy & Asthma Research Centre

Ottawa, Ontario, K1Y 4G2, Canada

Location

Division of Clinical Immunology and Allergy, The McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Anapharm

Montreal, Quebec, H3X 2H9, Canada

Location

Centre De Recherche Appliquée en Allergie De Québec

Québec, Quebec, GIV 4M6, Canada

Location

Related Publications (1)

• Campbell JD, Buchmann P, Kesting S, Cunningham CR, Coffman RL, Hessel EM. Allergen-specific T cell responses to immunotherapy monitored by CD154 and intracellular cytokine expression. Clin Exp Allergy. 2010 Jul;40(7):1025-35. doi: 10.1111/j.1365-2222.2010.03505.x. Epub 2010 Apr 13.

  PMID: 20412135 DERIVED

Related Links

• sponsor website

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity; Rhinitis, Allergic

Interventions

Histamine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Eduardo Martins, MD, DPhil

  Dynavax Technologies Corporation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)