A Novel Biologic Therapy for Perennial Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Allergen Immunotherapy Extract; Allergen Immunotherapy Control
Intervention description: Allergen Immunotherapy treatment mixture to be delivered subcutaneously; Allergen Immunotherapy Control Solution to be delivered subcutaneously
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept
      study which will evaluate the effect of a preparation of FDA approved allergens (PMA) used as
      a sub-cutaneously administered immunotherapy for the management of allergic rhinitis
      (perennial and seasonal).
    

Eligibility criteria:

        Inclusion Criteria:

          -  In the opinion of the investigator, the subject is capable of understanding and
             complying with protocol requirements.

          -  The subject signs and dates a written, informed consent form and any required privacy
             authorization prior to the initiation of any study procedures.

          -  The subject is a male or a non-pregnant, non-lactating female between the ages of 18
             and 65.

          -  The subject is actively manifesting symptoms and signs of moderate to severe Perennial
             Allergic Rhinitis (PAR) with or without Seasonal Allergic Rhinitis (SAR) component
             defined as score of at least 28 on the Rhinoconjunctivitis Quality of Life
             Questionnaire (RQLQ) and 6 on the Total Nasal Symptom Score (TNSS) scale. Scores will
             be determined on the first and second visit (after the 14 day medication washout
             period). Both scores exceeding their threshold on either day will qualify.

          -  Skin test strongly positive (wheal at least 5mm diameter and 2mm greater than negative
             control) to at least 6 of 48 allergy skin prick tests including at least one species
             of dust mite.

        Exclusion Criteria:

          -  The subject has received any investigational compound within 30 days prior to
             screening.

          -  The subject has received allergen immunotherapy or Sublingual immunotherapy (SLIT) in
             a previous clinical study or as a therapeutic agent within the past two years.

          -  The subject has a history or clinical manifestations of significant medical conditions
             (cardiovascular, hepatic, infectious or renal disease, etc.) which in the opinion of
             the investigator renders them unacceptable study subjects.

          -  The subject has a history of drug abuse (defined as any chronic illicit drug use) or a
             history of alcohol abuse within 5 years prior to the screening visit.

          -  The subject is required to take excluded medications listed in Section 6.3.

          -  If female, the subject is pregnant or lactating or intending to become pregnant
             before, during, or within 1 month after participating in this study; or intending to
             donate ova during such time period.

          -  Subjects found to have on physical exam significant nasal polyps, septal deviation or
             infectious sinusitis.

          -  The subject has a history of allergic rhinitis but is not currently manifesting active
             signs and symptoms of the disorder.

          -  Subject has a history of cancer, other than squamous cell or basal cell carcinoma of
             the skin that has not been in full remission for at least 5 years prior to Screening.
             (A history of treated Cervical Intraepithelial Neoplasia (CIN) I, II, or CIN III is
             allowed.)