Phase 2 Study in Adults Sensitized to Cat
Condition: Allergy
MeSH terms: Hypersensitivity
Intervention: Standardized Allergenic Extract, Cat Hair; Placebo
Intervention description: Standardized Cat Hair Allergenic Extract sublingual drops; Placebo Sublingual Drops
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Sublingual Immunotherapy (SLIT); Non-seasonal allergic rhinitis; Immunotherapy; Allergic rhinitis; Cat; Perennial allergy; Non-seasonal allergy

Summary:

      The purpose of this study is to identify an effective dose of allergen-specific immunotherapy
      for cat hair (Felis domesticus) administered by the oral/sublingual route.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients between ages of 18 and 55 years (inclusive).

          -  Written informed consent to participate in the study.

          -  Documented allergy to cat hair as demonstrated by a positive epicutaneous skin test
             (wheal >3 mm) and symptoms of allergic rhinitis during exposure to cats.

          -  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: hormonal begun >30 days prior to screening, barrier,
             intrauterine device or vasectomized partner (6 months minimum).

          -  No clinically significant abnormal findings on physical examination, with the
             exception of head, ears, eyes, nose, and throat (HEENT) findings consistent with
             allergic rhinitis, medical history, or clinical laboratory results during screening
             which would jeopardize the safety of the subject or impact validity of study results.

        Exclusion Criteria:

          -  Previous allergen immunotherapy (subcutaneous immunotherapy (SCIT), oral
             immunotherapy, sublingual immunotherapy (SLIT) or recombinant peptide) for cat within
             24 months of 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 Act (FD&C) Yellow #5, Red #40
             and Blue #1; 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
             clinical trial material (CTM), with the exception of protocol-specified rescue
             medications provided by the study site for use after Study Day 0. This includes, but
             is not limited to:

               -  Decongestants for 3 days prior to Study Day 0

               -  H1 antagonists (antihistamines) (oral, nasal or ocular) for 7 days prior to Study
                  Day 0

               -  Topical intranasal corticosteroids for 14 days prior to Study Day 0

               -  Cromolyn or nedocromil for 14 days prior to Study Day 0

               -  Systemic corticosteroids for 28 days prior to Study Day 0

               -  Tricyclic antidepressants for 28 days prior to Study Day 0

               -  Leukotriene modifiers for 7 days prior to 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 human immunodeficiency virus (HIV), Hepatitis B surface
             antigen (HbSAg), or Hepatitis C.

          -  Forced Expiratory Volume in 1 second (FEV1) <70% of the predicted value.

          -  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.