Cat-allergic asthma and Bronchoconstriction Upon Cat Allergen Challenge MedDRA version: 20.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10006464 Term: Bronchoconstriction System Organ Class: 100000004855
Conditions
Interventions
Product Name: REGN1908
Product Code: REGN1908
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: REGN1908
Current Sponsor code: REGN1908
Other descriptive name: HUMAN IG
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Generally healthy men and women between the ages of 18 and 65 inclusive at the time of screening. 2. Documented history (for at least 2 years) of symptomatic cat hair-triggered asthma with rhinitis with or without conjunctivitis as defined by all of the following criteria: a. Positive skin prick test (SPT) with cat hair extract (mean wheal diameter at least 5 mm greater than a negative control) at screening b. Positive allergen-specific IgE (sIgE) tests for cat hair and Fel d 1 (> 0.35 kAU/l at screening) c. History of asthma GINA 1 d. Screening FEV1 = 70% predicted after withholding long-acting ß2-agonists for > 36 hours and short-acting ß2-agonists for > 6 hours e. Screening asthma control test (ACT) = 20 at all screening visits f. Demonstrated = 20% fall in FEV1 within 2 hours during Cat Allergen Challenge in EEU and ability to withstand exposure for at least 10 minutes during screening 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide informed consent signed by study patient or legally acceptable representative 5. Patients covered by health social identification number 6. Able to understand and complete study related questionnaires 7. No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure outside of the home shall be avoided for at least one week prior to any Cat Allergen Challenge and during the defined follow-up period. 8. Less than 10 pack-years of smoking history Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 57 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Patients who experience a = 10% fall in FEV1 at 3 consecutive spirometry measurements during the placebo challenge 2. History of significant multiple and/or severe allergies (including latex gloves) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food 3. History of severe anaphylactic or severe asthmatic reactions to cat exposure 4. Active lung disease other than asthma 5. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening 6. Use of systemic corticosteroids within 8 weeks prior to screening visit 1 7. Use of anti-IgE or other biological therapy within 6 months prior to screening visit 1 8. History of SIT with cat allergen or vaccines against cat allergy within 5 years of screening visit 1 9. SIT with any allergen within 6 months prior to screening visit 1 10. Significant rhinitis (causing TNSS>2), or sinusitis, due to daily contact with other allergens causing symptoms that are expected to coincide with the baseline or the final cat allergen exposure unit assessments as assessed by the investigator, before each exposure 11. Patients who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the baseline or the final cat allergen exposure assessments as assessed by the investigator 12. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures 13. Treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within 12 months or once within 3 months prior to screening or has been hospitalized or has attended the ER/Urgent Care facility for asthma more than twice in prior 12 months before screening. 14. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the prophylactic efficacy of REGN1908-1909 (anti-Felis silvestris catus (domestic cat) allergen 1 (Fel d 1)) administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat in the prevention of a Controlled Cat Allergen Challenge induced Early Asthmatic Response (EAR) assessed by measures of lung function (Forced expiratory volume in one second: FEV1) compared to placebo-treated patients on day 8.;Secondary Objective: - To evaluate the prophylactic efficacy of REGN1908-1909, compared to placebo, administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat in the prevention of a controlled cat allergen challenge-induced: *early asthmatic response (EAR), assessed by measures of lung function (FEV1), on days 29, 57, and 85 *allergic rhinitis symptoms, assessed by total nasal symptom score, on days 8, 29, 57, and 85 *ocular symptoms, assessed by total ocular symptom score, on days 8, 29, 57, and 85 - To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat to increase the exposure to cat allergen required to induce EAR in a controlled cat allergen challenge as compared to placebo patients - To evaluate the safety and tolerability of REGN1908-1909 vs placebo in patients with cat allergen-triggered asthma ;Primary end point(s): Time to Early Asthmatic Response (EAR) upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU);Timepoint(s) of evaluation of this end point: Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Time to EAR upon Controlled Cat Allergen Challenge in an EEU on days 29, 57, and 85 2 - AUC of the percent change (%/h) in FEV1 induced by a Controlled Cat Allergen Challenge over the exposure interval (%/h) from baseline to the Controlled Cat Allergen Challenge on days 8, 29, 57, and 85 3 - AUC of the percent change (%/h) in patient-assessed nasal symptoms induced by a Controlled Cat Allergen Challenge over the exposure interval (%/h) from baseline to the Controlled Cat Allergen Challenge on days 8, 29, 57, and 85 4 - AUC of the percent change (%/h) in patient-assessed ocular symptoms induced by a Controlled Cat Allergen Challenge over the exposure interval (%/h) from baseline to the Controlled Cat Allergen Challenge on days 8, 29, 57, and 85 5 - Change and percent change in cat allergen quantity as experienced by patients during exposure (measured by 40 ng/m3 x minute ventilation x time) on days 8, 29, 57, and 85 6 - Incidence rates of treatment-emergent adverse events (TEAEs) and serious TEAEs through end of study;Timepoint(s) of evaluation of this end point: Days 29, 57, and 85 for timepoint 1. Days 8, 29, 57, and 85 for timepoints 2 to 5. | — |
Countries
France
Contacts
Public ContactClinical Trial Information
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed