E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic Rhino conjunctivitis due to Cat Allergy |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10001708 |
E.1.2 | Term | Allergic conditions |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 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 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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Future Biomedical Research (Optional) Patients who agree to participate in the future biomedical research (FBR) sub-study will be required to consent to this optional sub-study before samples are banked for FBR.
Pharmacogenomic Analysis (Optional) Patients who agree to participate in the genomics sub-study will be required to consent to this optional sub-study before collection of the samples. |
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E.3 | Principal inclusion criteria |
1. Generally healthy males and females who are 12 years and older at the time of screening 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 of at least 8/18 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 |
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E.4 | Principal exclusion criteria |
1. History of significant multiple and/or severe allergies that would potentially interfere with the assessments during the baseline and 12-week 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. FEV1 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 re-evaluated 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 potential (WOCBP) as described in the protocol
Additional protocol-defined exclusion criteria apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
Daily combined symptom and medication score (CSMS) averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
First 12 weeks of the treatment period |
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E.5.2 | Secondary end point(s) |
• Daily TNSS score averaged over the initial 12 weeks of treatment (weeks 0 to 12) in patients who receive REGN1908-1909 versus placebo • Daily TNSS averaged over the last 12 weeks of treatment (weeks 48 to 60) in patients who receive REGN1908-1909 versus placebo • Daily CSMS averaged over the last 12 weeks of treatment (weeks 48 to 60) in patients who receive REGN1908-1909 versus placebo • Daily TSS score averaged over the initial 12 weeks of treatment (weeks 0 to 12) in patients who receive REGN1908-1909 versus placebo • Daily TSS averaged over the last 12 weeks of treatment (weeks 48 to 60) in patients who receive REGN1908-1909 versus placebo • Percent change from baseline to the week 12 cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo • Percent change from baseline to the end of treatment (week 60) cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo • Percent change from baseline to week 12 FEV1 in patients with asthma who receive REGN1908-1909 versus placebo • Percent change from baseline to week 60 FEV1 in patients with asthma who receive REGN1908-1909 versus placebo • Daily TOSS averaged over the initial 12 weeks of treatment (weeks 0 to 12) in patients who receive REGN1908-1909 versus placebo • Daily TOSS averaged over the last 12 weeks of treatment (weeks 48 to 60) in patients who receive REGN1908-1909 versus placebo • Change from baseline to week 12 FEV1 in patients with asthma who receive REGN1908-1909 versus placebo • Change from baseline to week 60 FEV1 in patients with asthma who receive REGN1908-1909 versus placebo • Change from baseline to week 12 RQLQ(S)+12 in patients who receive REGN1908-1909 versus placebo • Change from baseline to week 60 RQLQ(S)+12 in patients who receive REGN1908-1909 versus placebo • DMS averaged over the initial 12 weeks of treatment (weeks 0 to 12) in patients who receive REGN1908-1909 versus placebo • DMS averaged over the last 12 weeks of treatment (weeks 48 to 60) in patients who receive REGN1908-1909 versus placebo • Percent change from baseline to end of study (week 72) in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo • Asthma daily symptom (ADS) score, averaged over the initial 12 weeks of the treatment period (weeks 0 to 12), using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in patients with asthma who receive REGN1908-1909 versus placebo • Change from baseline to week 12 in ACQ-5 in patients with asthma who receive REGN1908-1909 versus placebo • Change from baseline to week 60 in ACQ-5 in patients with asthma who receive REGN1908-1909 versus placebo • Daily frequency of asthma rescue medication use, averaged over the initial 12 weeks (weeks 0 to 12), in patients with asthma who receive REGN1908-1909 versus placebo • Daily number of nighttime awakenings averaged over the initial 12 weeks (weeks 0 to 12) in patients with asthma who receive REGN1908-1909 versus placebo • Incidence of TEAEs, AESIs, and serious TEAEs throughout the study (weeks 0 to 72) • Total REGN1908 and REGN1909 concentration in serum over the study duration (weeks 0 to 72) • Incidence of treatment-emergent anti-drug antibodies (ADAs) to REGN1908 and REGN1909 throughout the study (weeks 0 to 72) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
United States |
Belgium |
France |
Germany |
Poland |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as the date the last patient completes the last study visit or withdraws from the study, or is lost to follow-up (ie, the study patient can no longer be contacted by the investigator). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 23 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 25 |