Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic... | NCT00387738

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

May 2007Actual

Completion Date

Mar 2008Actual

First Submitted Date

Oct 11, 2006

First Submission Date that Met QC Criteria

Oct 11, 2006

First Posted Date

Oct 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.

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 study compares the safety and efficacy of two different dosing regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons.

Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

738Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	TOLAMBA™ dose-intense regimen	Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
2	Experimental	TOLAMBA™ lower-dose regimen	Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
3	Placebo Comparator		Biological: Histamine base

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate	Biological	Escalating doses, 6 weekly subcutaneous (under the skin) injections	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.		Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete
Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season

Exclusion Criteria:

Has had any hospital admissions for asthma
Has smoked within the past year, or has a ≥10-pack per year smoking history
Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™
Has used Xolair within the past 12 months
Has a history of anaphylaxis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eduardo Martins, MD, DPhil	Dynavax Technologies Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center Of Research Excellence		Oxford	Alabama	36203	United States
Atlanta Allergy & Asthma Clinic

References Module

Citations

Not provided

Label	URL
American Academy of Allergy, Asthma \& Immunology	View source
Dynavax Web Page	View source

ID	Term
D006255	Rhinitis, Allergic, Seasonal
D006967	Hypersensitivity
D012220	Rhinitis

ID	Term
D065631	Rhinitis, Allergic
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D007154	Immune System Diseases
D012141	Respiratory Tract Infections
D007239	Infections