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

Primary Purpose

Rhinitis, Allergic, Seasonal

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate

Histamine

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring ragweed, ragweed allergy, allergy, allergies, allergic, seasonal allergic rhinitis, allergic rhinitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Has moderate or severe allergy symptoms at Visit 1.

Sites / Locations

Allied Research International Inc.
Alpha Medical Research Inc.
Allergy & Asthma Research Centre
Division of Clinical Immunology and Allergy, The McGill University Health Centre
Anapharm
Centre De Recherche Appliquée en Allergie De Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TOLAMBA™

Histamine

Arm Description

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

Outcomes

Primary Outcome Measures

Total Nasal Symptom Score (TNSS)

Secondary Outcome Measures

Total Non-Nasal Symptom Score (TNNSS)

Total Symptom Score (TSS)

quality of life questionnaire

Full Information

NCT ID

NCT00537355

First Posted

September 27, 2007

Last Updated

April 11, 2019

Sponsor

Dynavax Technologies Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00537355

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of TOLAMBA™ in the Control of Symptoms of Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dynavax Technologies Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. 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. Comparison: Allergy symptoms of subjects treated with TOLAMBA™ compared with subjects treated with placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Seasonal

Keywords

ragweed, ragweed allergy, allergy, allergies, allergic, seasonal allergic rhinitis, allergic rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

271 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TOLAMBA™

Arm Type

Active Comparator

Arm Title

Histamine

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate

Other Intervention Name(s)

TOLAMBA™

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Histamine

Other Intervention Name(s)

Histatrol

Intervention Description

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

Primary Outcome Measure Information:

Title

Total Nasal Symptom Score (TNSS)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Total Non-Nasal Symptom Score (TNNSS)

Time Frame

3 months

Title

Total Symptom Score (TSS)

Time Frame

3 months

Title

quality of life questionnaire

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Has moderate or severe allergy symptoms at Visit 1.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Martins, MD, DPhil

Organizational Affiliation

Dynavax Technologies Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Allied Research International Inc.

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L4W 1N2

Country

Canada

Facility Name

Alpha Medical Research Inc.

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5A 3V4

Country

Canada

Facility Name

Allergy & Asthma Research Centre

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4G2

Country

Canada

Facility Name

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

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Anapharm

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3X 2H9

Country

Canada

Facility Name

Centre De Recherche Appliquée en Allergie De Québec

City

Quebec

ZIP/Postal Code

GIV 4M6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The IND for Tolamba was withdrawn. There is no intention to conduct clinical studies with this compound. All studies were conducted in Canada, no U.S. sites participated in study. CT PRS states "DR" status will be removed from study. 3/1/2017 - no update

Citations:

PubMed Identifier

20412135

Citation

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.

Results Reference

derived

Links:

URL

http://www.dynavax.com

Description

sponsor website

Learn more about this trial

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

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