allergic rhinitis cat allergy
Conditions
Interventions
Subcutanous injection with IP, intranasal challenge to Allergic Rhinitis with
Allergen Extract, Skin Prick Test, venapunction, questionaires.
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Generally healthy men and women between the ages of 18 and 55, inclusive; 2. Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive; 3. History of allergic rhinitis which is exacerbated by exposure to cats; 4. Cat sensitization confirmed at screening by both: i) positive skin prick test with cat hair extract (mean wheal diameter at least 3mm greater than negative control) ii) positive allergen-specific IgE tests for cat dander and Fel d 1 *0.35 kAU/I for both allergens); 5. Positive NAC (which is defined as a peak TNSS score >7 [on a 12-point scale], and with a prechallenge TNSS *2) upon nasal allergen challenge with cat hair extract at screening 6. Normal lung function as judged by the investigator. Asthma subjects must have forced expiratory volume in 1 second (FEV1) * 80% of expected value at screening. 7. Willing and able to comply with clinic visits and study-related procedures 8. Provide signed informed consent 9. Able to understand and complete study-related questionnaires
Exclusion criteria
Exclusion criteria: 1. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals or untreated respiratory infections within 4 weeks prior to the screening visit. 2. Serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]), total bilirubin (unless the Investigator has evidence that increased indirect bilirubin corresponds to a Gilbert*s-type syndrome) that exceed 1.5 x the upper limit of normal (1.5 x ULN), or any laboratory findings showing evidence of organ dysfunction or any clinically significant deviation from the normal range, as decided by the Investigator at the screening visit 3. Any clinically significant physical exam abnormalities observed during the screening visit 4. Any gross mechanical nasal obstruction, or history of nasal or sinus surgery that may interfere with the conduct of the NAC as per judgment of the Investigator. 5. Use of any concomitant medications within 3 weeks of the screening visit including antihistamines, leukotriene inhibitors, mast cell inhibitors, topical corticosteroids including intranasal corticosteroids, oral or topical decongestants, topical calcineurin inhibitors, beta blockers, nutritional supplements, over-the-counter medications, and use of systemic corticosteroids within 12 weeks. 6. Use of anti-IgE therapy within 6 months prior to screening. 7. History of SIT with cat allergen and vaccines against cat allergy 8. SIT with any allergen within 3 months prior to screening 9. Habitation in a household with 1 or more cats or chronic exposure to cats within 3 months prior to the screening visit and during the duration of the study 10. Subjects with grass, tree, or Artemesia sensitization (confirmed at screening by both a positive skin prick test and a positive allergen-specific IgE test [> 0.35 kAU/l] for respective allergens) may only be enrolled at the end of regional pollen season and at the discretion of the investigator. Note: In view of regional variations on allergen exposure, the appropriate seasonal allergen will be tested. 11. Subjects who anticipate major changes in allergen exposure in their home or work environments during the course of the study as assessed by the Investigator. 12. Subjects receiving therapy with any agents known or likely to interact with adrenaline (eg, beta blockers, ACE-inhibitors, tri-cyclic antidepressants, or other drugs), within 3 weeks prior to screening 13. Hospitalization for any reason within 30 days of the screening visit 14. Asthma requiring chronic treatment (except asthma subjects treated with intermittent salbutamol) or atopic dermatitis requiring treatment with topical or systemic corticosteroids and/or calcineurin inhibitors within 6 months prior to screening 15. Human immunodefieciency virus (HIV) infection or HIV seropositivity at the screening visit 16. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit 17. Known sensitivity to doxycycline or to any of the components of the Investigational Product formulation 18. History of severe asthmatic reaction or anaphylaxis after exposure to cats 19. Participation in any clinical research study evaluating another investigational drug or therapy within 90 days or at least 5 half-lives (whichever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in TNSS AUC between day 8 and pretreatment NAC over the first hour of the challenge (0 hour to hour 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from pretreatment NAC to days 29, 57, and 85 in TNSS AUC over the first hour of the initial challenge (0 hour to hour 1) - Change from pretreatment NAC to days 8, 29, 57, and 85 in TNSS AUC during hour 1 to hour 8 of the initial challenge - Incidence rates of treatment-emergent adverse events (TEAEs) and serious TEAEs through day 85 in subjects treated with a single 600 mg SC dose of REGN1908-1909 or placebo - Characterization of the key PK parameters of REGN1908 and REGN1909 following SC coadministration at a 1:1 ratio. | — |
Countries
Netherlands
Outcome results
None listed