Allergic Rhino conjunctivitis due to Cat Allergy MedDRA version: 20.0 Level: HLGT Classification code 10001708 Term: Allergic conditions System Organ Class: 10021428 - Immune system disorders
Conditions
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Generally healthy males and females who are 12 years and older at the time of screening. Note that for those countries where local regulations or approvals permit enrollment of adults only, subject recruitment will be restricted to those who are =18 years of age. 2. Weight must be =40 kg at the time of screening 3. Documented or patient reported history (for at least 2 years) of symptomatic cat allergen triggered allergic rhinitis with or without conjunctivitis and with or without asthma as defined in the protocol 4. At least 1 generally healthy cat (that is unlikely to die during the study) living in the home resulting in regular exposure 5. A daily total rhinitis/conjunctivitis symptom score (total symptom score [TSS]) of at least 8 of 18 during at least 8 days of the 15-day baseline assessment period and use of standard, therapeutic doses of pharmacotherapy for the treatment of allergic rhinoconjunctivitis on at least 8 days of the 15-day baseline assessment period 6. Willing and able to comply with clinic visits and study-related procedures 7. Provide informed consent signed by study patient or legally acceptable representative as described in the protocol 8. Able to understand and complete study-related questionnaires Additional protocol-defined inclusion criteria apply Are the trial subjects under 18? yes Number of subjects for this age range: 65 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1. History of significant multiple and/or severe allergies that would potentially interfere with the assessments during the baseline and 12week efficacy assessment periods or confound results, per investigator discretion, including significant rhinitis or sinusitis due to daily contact with other allergens causing symptoms that are expected to coincide with the baseline period or any of the efficacy assessment periods 2. Received REGN1908-1909 in a prior REGN1908-1909 clinical trial (receipt of placebo in a previous trial is allowed) 3. Active lung disease other than asthma 4. Forced expiratory volume (FEV)1 less than 70% of predicted at screening or randomization 5. Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening 6. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening. Patients may be reevaluated after resolution of symptoms and specified time duration 7. 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 as defined in the protocol 8. Any medical illness, which in the judgment of the investigator could preclude participation in the study or in whom treatment with epinephrine or beta-2 agonists or systemic corticosteroids would pose an increased risk (eg, history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease etc.) 9. 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 10. History of intensive care hospitalization for asthma within past 2 years 11. Positive serum human chorionic gonadotropin pregnancy test at the screening visit or randomization visit for women of childbearing 1. History of significant multiple and/or severe allergies that would potentially interfere with the assessments during the baseline and 12week efficacy assessment periods or confound results, per investigator potential (WOCBP) as described in the protocol Additional protocol-defined exclusion criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of REGN1908-1909, as compared to placebo, to reduce allergic rhinitis/conjunctivitis symptoms and allergy rescue medication use during natural cat exposure;Secondary Objective: The key secondary objectives are: • The key secondary objectives are: • To assess the reduction of allergic symptoms and use of allergy rescue medications after treatment with REGN1908-1909 versus placebo, as measured by the individual components of the combined symptom and medication score (CSMS) • To assess health-related quality of life (HRQoL) as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) • To determine the efficacy of REGN1908-1909, as compared to placebo, to inhibit a wheal-and-flare response to a skin prick test (SPT) with cat allergen • To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN 1908-1909 compared to placebo given every 12 weeks (Q12W) • To determine the efficacy following multiple doses of REGN1908-1909 compared to placebo at inhibiting a wheal-and-flare response to a skin prick test with cat allergen ;Primary end point(s): Daily combined symptom and medication score (CSMS) averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo ;Timepoint(s) of evaluation of this end point: Weeks 48 to 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •1. Daily total nasal symptom score (TNSS), averaged over the last 12 weeks of treatment period, in patients who receive REGN1908-1909 versus placebo 2. Percent change from pre-treatment baseline in average CSMS, over the last 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 3. Percent change from pre-treatment baseline in average TNSS, over the last 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 4. Daily total symptom score (TSS), averaged over the last 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 5. Percent change from pre-treatment baseline in average TSS, over the last 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 6. Percent change from baseline to the end of treatment in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo 7. Daily CSMS, averaged over the initial 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 8. Daily TNSS, averaged over the initial 12 weeks of treatment period, in patients who receive REGN1908-1909 versus placebo 9. Percent change from pre-treatment baseline in average CSMS, over the initial 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 10. Percent change from pre-treatment baseline in average TNSS, over the initial 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 11. Percent change from pre-treatment baseline in average TSS, over the initial 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 12. Daily TSS score, averaged over the initial 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus placebo 13. Percent change from pre-treatment baseline in average TOSS, over the initial 12 weeks of the treatment period, in patients who receive REGN1908-1909 versus p | — |
Countries
Belgium, Canada, France, Germany, Poland, United States
Contacts
Public ContactClinical Trial Information
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed