Phase 2 Study in Adults Sensitized to Short Ragweed

January 8, 2014 updated by: Antigen Laboratories, Inc.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy in Adults Sensitized to the Standardized Allergenic Extract, Short Ragweed (Ambrosia Artemisiifolia)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Clinical Trial Material (CTM): hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm with spermicide), Intrauterine Device (IUD), or vasectomized partner (6 months minimum).
  • No clinically significant abnormal findings on the physical examination, with the exception of head, eyes, ears, nose and throat (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 (subcutaneous immunotherapy (SCIT), oral immunotherapy, sublingual 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, Food, Drug and Cosmetic (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
Sublingual drops
Active Comparator: Dose Group A
Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Sublingual drops
Active Comparator: Dose Group B
Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Sublingual drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average of Total Symptom Scores
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antigen Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALI001-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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