Phase 2 Study in Adults Sensitized to Cat

NCT00689299 | Completed Phase 2 Results

• 1 other identifier: ALI002-08
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Allergy

Keywords

Sublingual Immunotherapy (SLIT); Non-seasonal allergic rhinitis; Immunotherapy; Allergic rhinitis; Cat; Perennial allergy; Non-seasonal allergy

Outcome Measures

Primary Outcomes (1)

• Scores on a Scale (Average of Total Symptom Scores)

  Sum of individual symptoms scores, 7 items, 21 points maximum Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat. Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures.

  20 weeks

Study Arms (3)

Dose Group C

PLACEBO COMPARATOR

Standardized Allergenic Extract, Cat Hair (Felis domesticus) placebo

Biological: Placebo

Dose Group A

ACTIVE COMPARATOR

Standardized Allergenic Extract, Cat Hair (Felis domesticus) 0.21 Units

Biological: Standardized Allergenic Extract, Cat Hair

Dose Group B

ACTIVE COMPARATOR

Standardized Allergenic Extract, Cat Hair (Felis domesticus)2.1 units

Biological: Standardized Allergenic Extract, Cat Hair

Interventions

Standardized Allergenic Extract, Cat Hair BIOLOGICAL

Standardized Cat Hair Allergenic Extract sublingual drops

Also known as: Standardized Cat Hair Allergenic Extract

Dose Group A; Dose Group B

Placebo BIOLOGICAL

Placebo Sublingual Drops

Dose Group C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Antigen Laboratories, Inc.: lead

Study Sites (3)

Allergy & Asthma Medical Group & Research Center

San Diego, California, 92123, United States

Location

Allergen Response and Research Center

Marietta, Georgia, 30062, United States

Location

Clinical Research Center

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Limitations and Caveats

Adverse events: 41%, 58%, and 45% \> 5% in Group A, B, and C, respectively.

Results Point of Contact

• Title: Mark Hites
• Organization: Greer Laboratories, Inc. for Antigen Laboratories, Inc.

mhites@greerlabs.com

828-759-7548

Study Officials

• Robert B. Berkowitz, M.D.

  Allergen Response Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 1, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-04

Locations

US (3)