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Phase 2 Study in Adults Sensitized to Short Ragweed
This study is not yet open for participant recruitment.
Verified by Antigen Laboratories, Inc., April 2008
Sponsored by: Antigen Laboratories, Inc.
Information provided by: Antigen Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00670384
  Purpose

The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for short ragweed (Ambrosia artemisiifolia)administered by an oral/sublingual route.


Condition Intervention Phase
Allergic Rhinitis
Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Biological: Placebo
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2 Randomized, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy in Adults Sensitized to the Standardized Allergenic Extract, Short Ragweed (Ambrosia Artemisiifolia)

Further study details as provided by Antigen Laboratories, Inc.:

Primary Outcome Measures:
  • Average of Total Symptom Scores [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Arms Assigned Interventions
Dose Group A: Active Comparator Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Sublingual drops
Dose Group B: Active Comparator Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Sublingual drops
Placebo: Placebo Comparator Biological: Placebo
Sublingual drops

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male and female patients between the ages of 18 and 55 years (inclusive.
  • Written informed consent to participate in the study.
  • Documented allergy to short ragweed pollen as demonstrated by a positive epicutaneous skin test (wheal >3 mm) and symptoms of allergic rhinitis during the two previous short ragweed seasons.
  • Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the 4 week follow-up period following the last dose of CTM: hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
  • No clinically significant abnormal findings on the physical examination, with the exception of HEENT findings consistent with allergic rhinitis, medical history, or clinical laboratory results during screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.

Exclusion Criteria:

  • Previous allergen immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide) for short ragweed within 24 months of the Screening Visit.
  • History of severe allergic reaction requiring medical intervention.
  • Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide).
  • Allergy to any of the non-antigen ingredients in the study drug formulation, including, but not limited to, FD&C Yellow #5, sodium chloride, sodium bicarbonate, and glycerine.
  • History of asthma requiring daily medication.
  • Subjects receiving anti-IgE monoclonal antibodies.
  • Congenital immune deficiency or acquired immune suppression. Causes of acquired immune suppression may include, but are not limited to, systemic illnesses such as malignancy and infection, the use of medications such as corticosteroids and chemotherapeutic agents, and radiation therapy.
  • History of organ transplant, hematologic malignancy, autoimmune disease, myocardial infarction, or congestive heart failure.
  • History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
  • Inability or unwillingness to stop using drugs that may inhibit the wheal-and-flare reaction or rhinitic response prior to the study and for the duration of dosing CTM (with the exception of protocol-specified rescue medications provided by the study site for use after Study Day 0).
  • Inability or unwillingness to stop using drugs that may inhibit the ability to treat a severe allergic adverse event. This includes, but is not limited to: beta blockers such as atenolol (Tenormin), metoprolol (Lopressor, Toprol-XL) and propranolol (Inderal, Inderal LA) for 14 days prior to Study Day 0 and for the duration of the study
  • Female subjects who are trying to conceive, are pregnant, or are lactating.
  • Positive serum pregnancy test at screening or a positive human chorionic gonadotropin (HCG) urine test on Study Day 0 prior to administration of study drug for women of childbearing potential.
  • Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C.
  • History of alcohol or drug abuse within the year prior to the Screening Visit, or current evidence of substance dependence or abuse.
  • Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670384

Contacts
Contact: Robert B. Berkowitz, M.D. 770-592-4210 BBerkowitz@atlantaallergy.com

Locations
United States, Georgia
Rx Research
Atlanta, Georgia, United States, 30188
Sponsors and Collaborators
Antigen Laboratories, Inc.
  More Information

Responsible Party: Antigen Laboratories, Inc. ( Linda Brown/Responsible Head )
Study ID Numbers: ALI001-08
Study First Received: April 29, 2008
Last Updated: April 29, 2008
ClinicalTrials.gov Identifier: NCT00670384  
Health Authority: United States: Food and Drug Administration

Keywords provided by Antigen Laboratories, Inc.:
SLIT
Immunotherapy
Short ragweed
SAR
Seasonal allergic rhinitis

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
SARS
Rhinitis, Allergic, Seasonal
Rhinitis

Additional relevant MeSH terms:
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009