Cat Allergy, Cat Hypersensitivity
Conditions
Keywords
cat-allergic, cat immunotherapy, anti-thymic stromal lymphopoietin (anti-TSLP)
Brief summary
This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP \[thymic stromal lymphopoietin\] antibody being co-developed by Amgen and MedImmune) can lead to lasting tolerance to cat allergen.The objective of the study is to determine whether one year of immunotherapy combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.
Detailed description
This study will implement the concept referred to as allergen-plus, which aims to enhance the disease-modifying mechanisms of allergen-specific immunotherapy by combining it with other anti-inflammatory or immune-modulating agents. Thymic stromal lymphopoietin (TSLP) is a cytokine which appears to be instrumental in both initiating and maintaining allergic sensitivity to antigens, and Immune Tolerance Network (ITN) investigators hypothesize that blocking TSLP during the administration of cat immunotherapy will induce durable immune changes that lead to tolerance. CATNIP will be conducted at multiple sites in the US and enroll cat-allergic adults who will be randomized to four possible treatment groups: immunotherapy plus MEDI9929/AMG 157, immunotherapy plus placebo, placebo plus MEDI9929/AMG 157, or two corresponding placebos. This study is specifically enrolling cat allergic individuals who do not live with cats in order to limit exposure to the allergen outside of the study. Treatment will be given for about one year, followed by one year off therapy.
Interventions
BIOLOGICALAMG 157
AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
BIOLOGICALCat Immunotherapy
A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
BIOLOGICALCat Immunotherapy Placebo
Placebo for allergen-specific immunotherapy administered subcutaneously
BIOLOGICALAMG 157 Placebo
Placebo for AMG 157 administered intravenously
Sponsors
Immune Tolerance Network (ITN)
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* History of moderate-severe allergic rhinitis caused by cat exposure for at least 2 yrs * Skin prick test wheal \>/=5 mm to standardized cat extract * Immunoglobulin E (IgE) \>/=0.7 kU/L (class 2) to cat extract * Screening nasal allergen challenge in which: \*TNSS is \</= 3 after the 0 concentration (vehicle control only) dose, * TNSS increase is \</=1 from the TNSS prior to allergen administration to the TNSS after the 0 concentration (vehicle control only) dose, * TNSS is \>/=8 after the highest dose, and * Between the first non-zero dose and 10 minutes after the highest dose,either: * \>/=3 sneezes are counted or * \>20% drop in PNIF is recorded * Body mass index (BMI) between 1 and 32 kg/m\^2, inclusive at screening * Clinically acceptable physical examination and electrocardiogram (ECG) results (12-lead reporting RR, PR, QRS, QT and QTcF) prior to Day 0 based on the opinion of the investigator * Adequate renal function (defined by creatinine clearance \>80 mL/min using the Cockcroft Gault equation) * For women of childbearing age, a willingness to use a highly effective form of contraception for five months after last dose of study medication. Highly effective methods of birth control include abstinence, vasectomy by the male partner, or a condom with spermicide in combination with either hormonal birth control, IUD or barrier methods used by the woman. * For men with female partners of childbearing potential, agreement not to donate sperm and to inform their female partner of their participation in this clinical study and use highly effective methods of birth control for five months after last dose of study medication. Highly effective methods of birth control include abstinence, vasectomy, or a condom with spermicide in combination with either hormonal birth control, Intrauterine device (IUD) or barrier methods used by the woman. * The ability to give informed consent and comply with study procedures
Exclusion criteria
* Prebronchodilator Forced Expiratory Volume at one second (FEV1) less than 0% of predicted value at screening visit * History of moderate or higher Allergic Rhinitis and its Impact on Asthma (ARIA) severity classification for allergic rhinitis in the last year due to allergens other than cat * History of asthma meeting the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 (EPR3) classification of mild-persistent or worse in the past year, other than with cat exposure, requiring regular inhaled corticosteroids for \>4 weeks per year * History of serious chronic medical conditions which might interfere with treatment or assessments * History of emergency visit or hospital admission for asthma in the previous 12 months * History of chronic obstructive pulmonary disease (COPD) * History of significant recurrent acute sinusitis, defined as 2 episodes/yr for the last 2 years, all of which required antibiotic treatment * History of chronic sinusitis, defined as a sinus symptoms lasting \>12 weeks that includes \>/=2 major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, purulent or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness. * History of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease, or immunodeficiency, where, in the opinion of the study physician, participation in the trial would pose a risk or significant effect on the immune system * Diabetes (Type I or II) * Evidence of any active or suspected bacterial, viral, fungal or parasitic infection(s) within 30 days prior to randomization * High risk of parasitic disease as judged by the investigator * Positive QuantiFERON(R) tuberculin test UNLESS the potential subject has been treated with appropriate chemoprophylaxis * Exposure to an individual with active tuberculosis within six months from randomization * Subjects tested positive for HIV antibody, Hep B surface antigen, or Hep C antibody * At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve. * History of malignancy of any type, including basal cell and squamous cell cancers of the skin, within 5 years of enrollment * Tobacco smoking (ANY) within the last year or a history of \>/=10 pack years * Previous immunotherapy treatment with cat allergen within the previous 10 yrs * Any history of grade 4 anaphylaxis due to any cause as defined by the CTCAE grading criteria for immunotherapy * History of bleeding disorders or treatment with anticoagulation therapy * Treatment with omalizumab within 6 months prior to randomization * Currently taking any of the following medications: beta blockers; tricyclic antidepressants; monoamine oxidase inhibitors; or anti-IgE monoclonal antibody treatment * Ongoing systemic immunosuppressive treatment * History of intolerance to the study therapy, rescue medications, or their excipients * For women of childbearing age a positive serum or urine pregnancy test with sensitivity of \<50 mIU/mL within 72 hours before the start of study therapy * The use of any investigational drug within 6 months of randomization * The presence of any medical condition that the investigator deems incompatible with participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | 0 to 1 hour of the NAC at Week 104 | TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Early Phase Response (EPR) to Intradermal Testing | 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104 | Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Early Phase Response (EPR) is the response measured at 15 minutes after application. |
| Skin Late Phase Response (LPR) to Intradermal Testing | 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104 | Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Late Phase Response (LPR) is the response measured at 6 hours after application. |
| Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 | TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. Peak TNSS EPR is the highest value recorded between 0 and 1 hour inclusive. |
| Skin Prick Test Endpoint Titration | 15 minutes after Time 0 of the skin prick titration test at: Baseline (Week 0) and Weeks 1, 4, 12, 26, 52, 78 and 104 | A dilution series of standardized cat allergen extracts were applied in duplicate on the participant's upper back. Wheal size was assessed 15 minutes after application. |
| Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104 | TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours. |
| Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104 | PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Early Phase Response (EPR) is the PNIF AUC from 0 to 1 hour of the NAC. |
| Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104 | PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC. |
| Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 | TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour. |
Countries
United States
Participant flow
Recruitment details
Participants ages 18 years to 65 years with a history of moderate to severe allergic rhinitis caused by cat exposure were recruited from 9 clinical centers in the United States from March 3, 2015 to March 21, 2017.
Participants by arm
| Arm | Count |
|---|---|
| AMG 157+Cat Immunotherapy AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection | 32 |
| AMG 157 Placebo+Cat Immunotherapy Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously | 31 |
| AMG 157+Cat Immunotherapy Placebo AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously | 30 |
| Placebo-Placebo Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously | 28 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 2 | 4 | 6 |
| Overall Study | Physician Decision | 2 | 0 | 0 | 1 |
| Overall Study | Pregnancy | 0 | 0 | 1 | 1 |
| Overall Study | Site Error | 1 | 2 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 4 | 1 |
Baseline characteristics
| Characteristic | AMG 157+Cat Immunotherapy | AMG 157 Placebo+Cat Immunotherapy | AMG 157+Cat Immunotherapy Placebo | Placebo-Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 29 Participants | 30 Participants | 27 Participants | 116 Participants |
| Age, Continuous | 29.4 years STANDARD_DEVIATION 10.52 | 30.4 years STANDARD_DEVIATION 8.86 | 31.9 years STANDARD_DEVIATION 9.92 | 30.5 years STANDARD_DEVIATION 10.91 | 30.5 years STANDARD_DEVIATION 9.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 3 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 27 Participants | 27 Participants | 22 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 1 Participants | 3 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 28 Participants | 24 Participants | 24 Participants | 97 Participants |
| Region of Enrollment United States | 32 Participants | 31 Participants | 30 Participants | 28 Participants | 121 Participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 16 Participants | 15 Participants | 75 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 14 Participants | 13 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 25 / 32 | 18 / 31 | 18 / 29 | 19 / 28 |
| serious Total, serious adverse events | 1 / 32 | 3 / 31 | 0 / 29 | 0 / 28 |
Outcome results
Primary
Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy.
Time frame: 0 to 1 hour of the NAC at Week 104
Population: Intent-to-treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | 2.46 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | 2.81 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | 3.66 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | 3.10 Total Nasal Symptom Score * Hour |
p-value: 0.31495% CI: [-1.51, 0.49]Longitudinal repeated measures analysis
Secondary
Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)
PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Early Phase Response (EPR) is the PNIF AUC from 0 to 1 hour of the NAC.
Time frame: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104
Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 104 | -11.35 L/min * Hour |
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 52 | -8.65 L/min * Hour |
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Baseline | -15.14 L/min * Hour |
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 26 | -2.88 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Baseline | -10.66 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 26 | 2.26 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 104 | -11.90 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 52 | -4.90 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 52 | -0.80 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Baseline | -12.48 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 26 | -11.04 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 104 | -9.13 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Baseline | -10.25 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 52 | -8.70 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 104 | -13.09 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | Week 26 | -8.02 L/min * Hour |
Secondary
Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC
PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC.
Time frame: Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104
Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 78 | -31.93 L/min * Hour |
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 26 | -18.34 L/min * Hour |
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 104 | -43.41 L/min * Hour |
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 52 | -25.29 L/min * Hour |
| AMG 157+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Baseline | -52.24 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 52 | -23.42 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 78 | -24.55 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 104 | -35.98 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 26 | -17.35 L/min * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Baseline | -53.44 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 52 | -35.87 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Baseline | -42.49 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 26 | -40.42 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 78 | -37.56 L/min * Hour |
| AMG 157+Cat Immunotherapy Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 104 | -49.01 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 78 | -42.26 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 26 | -53.97 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Baseline | -50.03 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 52 | -44.71 L/min * Hour |
| Placebo-Placebo | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Week 104 | -52.42 L/min * Hour |
Secondary
Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. Peak TNSS EPR is the highest value recorded between 0 and 1 hour inclusive.
Time frame: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104
Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 78 | 4.24 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Baseline | 9.31 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 104 | 4.67 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 26 | 3.64 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 52 | 3.04 Peak Total Nasal Symptom Score |
| AMG 157 Placebo+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 26 | 5.41 Peak Total Nasal Symptom Score |
| AMG 157 Placebo+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 78 | 4.80 Peak Total Nasal Symptom Score |
| AMG 157 Placebo+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 104 | 6.16 Peak Total Nasal Symptom Score |
| AMG 157 Placebo+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Baseline | 9.52 Peak Total Nasal Symptom Score |
| AMG 157 Placebo+Cat Immunotherapy | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 52 | 4.73 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 26 | 6.78 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 52 | 6.09 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Baseline | 9.17 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 78 | 6.82 Peak Total Nasal Symptom Score |
| AMG 157+Cat Immunotherapy Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 104 | 6.85 Peak Total Nasal Symptom Score |
| Placebo-Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 78 | 5.83 Peak Total Nasal Symptom Score |
| Placebo-Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Baseline | 8.96 Peak Total Nasal Symptom Score |
| Placebo-Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 52 | 6.75 Peak Total Nasal Symptom Score |
| Placebo-Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 26 | 7.96 Peak Total Nasal Symptom Score |
| Placebo-Placebo | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | Week 104 | 6.12 Peak Total Nasal Symptom Score |
Secondary
Skin Early Phase Response (EPR) to Intradermal Testing
Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Early Phase Response (EPR) is the response measured at 15 minutes after application.
Time frame: 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104
Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Skin Early Phase Response (EPR) to Intradermal Testing | Week 104 | 11.04 mm |
| AMG 157+Cat Immunotherapy | Skin Early Phase Response (EPR) to Intradermal Testing | Week 52 | 10.65 mm |
| AMG 157+Cat Immunotherapy | Skin Early Phase Response (EPR) to Intradermal Testing | Week 26 | 11.21 mm |
| AMG 157+Cat Immunotherapy | Skin Early Phase Response (EPR) to Intradermal Testing | Baseline | 16.05 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Early Phase Response (EPR) to Intradermal Testing | Week 26 | 11.65 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Early Phase Response (EPR) to Intradermal Testing | Week 104 | 12.09 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Early Phase Response (EPR) to Intradermal Testing | Baseline | 15.34 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Early Phase Response (EPR) to Intradermal Testing | Week 52 | 10.69 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Early Phase Response (EPR) to Intradermal Testing | Baseline | 15.98 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Early Phase Response (EPR) to Intradermal Testing | Week 104 | 12.63 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Early Phase Response (EPR) to Intradermal Testing | Week 52 | 13.35 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Early Phase Response (EPR) to Intradermal Testing | Week 26 | 14.15 mm |
| Placebo-Placebo | Skin Early Phase Response (EPR) to Intradermal Testing | Week 104 | 13.21 mm |
| Placebo-Placebo | Skin Early Phase Response (EPR) to Intradermal Testing | Week 26 | 14.64 mm |
| Placebo-Placebo | Skin Early Phase Response (EPR) to Intradermal Testing | Week 52 | 14.21 mm |
| Placebo-Placebo | Skin Early Phase Response (EPR) to Intradermal Testing | Baseline | 16.52 mm |
Secondary
Skin Late Phase Response (LPR) to Intradermal Testing
Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Late Phase Response (LPR) is the response measured at 6 hours after application.
Time frame: 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104
Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Skin Late Phase Response (LPR) to Intradermal Testing | Baseline | 32.62 mm |
| AMG 157+Cat Immunotherapy | Skin Late Phase Response (LPR) to Intradermal Testing | Week 26 | 13.50 mm |
| AMG 157+Cat Immunotherapy | Skin Late Phase Response (LPR) to Intradermal Testing | Week 104 | 15.58 mm |
| AMG 157+Cat Immunotherapy | Skin Late Phase Response (LPR) to Intradermal Testing | Week 52 | 13.67 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Late Phase Response (LPR) to Intradermal Testing | Baseline | 23.41 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Late Phase Response (LPR) to Intradermal Testing | Week 104 | 14.48 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Late Phase Response (LPR) to Intradermal Testing | Week 26 | 13.83 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Late Phase Response (LPR) to Intradermal Testing | Week 52 | 10.06 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Late Phase Response (LPR) to Intradermal Testing | Baseline | 27.22 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Late Phase Response (LPR) to Intradermal Testing | Week 104 | 25.40 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Late Phase Response (LPR) to Intradermal Testing | Week 52 | 23.23 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Late Phase Response (LPR) to Intradermal Testing | Week 26 | 26.44 mm |
| Placebo-Placebo | Skin Late Phase Response (LPR) to Intradermal Testing | Week 104 | 32.38 mm |
| Placebo-Placebo | Skin Late Phase Response (LPR) to Intradermal Testing | Baseline | 34.65 mm |
| Placebo-Placebo | Skin Late Phase Response (LPR) to Intradermal Testing | Week 52 | 29.36 mm |
| Placebo-Placebo | Skin Late Phase Response (LPR) to Intradermal Testing | Week 26 | 31.28 mm |
Secondary
Skin Prick Test Endpoint Titration
A dilution series of standardized cat allergen extracts were applied in duplicate on the participant's upper back. Wheal size was assessed 15 minutes after application.
Time frame: 15 minutes after Time 0 of the skin prick titration test at: Baseline (Week 0) and Weeks 1, 4, 12, 26, 52, 78 and 104
Population: A cross-sectional analysis of the observed measures within the intent-to-treat population was used in the reporting of secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 12 | 30.12 mm |
| AMG 157+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 78 | 22.21 mm |
| AMG 157+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 1 | 45.92 mm |
| AMG 157+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 52 | 21.34 mm |
| AMG 157+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 26 | 21.96 mm |
| AMG 157+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Baseline | 45.11 mm |
| AMG 157+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 4 | 39.24 mm |
| AMG 157+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 104 | 26.88 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 12 | 22.08 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Baseline | 46.29 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 104 | 26.67 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 1 | 50.25 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 4 | 35.44 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 26 | 22.21 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 52 | 16.84 mm |
| AMG 157 Placebo+Cat Immunotherapy | Skin Prick Test Endpoint Titration | Week 78 | 25.13 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Prick Test Endpoint Titration | Week 104 | 39.82 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Prick Test Endpoint Titration | Week 52 | 34.92 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Prick Test Endpoint Titration | Baseline | 45.01 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Prick Test Endpoint Titration | Week 78 | 32.28 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Prick Test Endpoint Titration | Week 26 | 43.93 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Prick Test Endpoint Titration | Week 4 | 44.01 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Prick Test Endpoint Titration | Week 12 | 45.85 mm |
| AMG 157+Cat Immunotherapy Placebo | Skin Prick Test Endpoint Titration | Week 1 | 43.33 mm |
| Placebo-Placebo | Skin Prick Test Endpoint Titration | Week 52 | 39.64 mm |
| Placebo-Placebo | Skin Prick Test Endpoint Titration | Week 12 | 44.74 mm |
| Placebo-Placebo | Skin Prick Test Endpoint Titration | Week 26 | 43.40 mm |
| Placebo-Placebo | Skin Prick Test Endpoint Titration | Baseline | 44.49 mm |
| Placebo-Placebo | Skin Prick Test Endpoint Titration | Week 104 | 36.19 mm |
| Placebo-Placebo | Skin Prick Test Endpoint Titration | Week 78 | 39.32 mm |
| Placebo-Placebo | Skin Prick Test Endpoint Titration | Week 4 | 41.58 mm |
| Placebo-Placebo | Skin Prick Test Endpoint Titration | Week 1 | 44.06 mm |
Secondary
Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour.
Time frame: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104
Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 78 | 2.04 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 26 | 1.83 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 104 | 2.46 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 52 | 1.53 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Baseline | 5.49 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 52 | 2.34 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 78 | 2.31 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 104 | 2.81 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 26 | 2.71 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Baseline | 5.59 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 52 | 3.07 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Baseline | 4.91 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 26 | 3.38 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 78 | 3.23 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 104 | 3.66 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 78 | 2.88 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 26 | 4.09 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Baseline | 5.55 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 52 | 3.77 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | Week 104 | 3.10 Total Nasal Symptom Score * Hour |
Secondary
Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours.
Time frame: Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104
Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Baseline | 1.36 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 26 | 0.30 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 52 | 0.48 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 104 | 0.69 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 104 | 1.02 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 26 | 0.67 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Baseline | 1.52 Total Nasal Symptom Score * Hour |
| AMG 157 Placebo+Cat Immunotherapy | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 52 | 0.60 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 26 | 0.54 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Baseline | 1.13 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 104 | 0.53 Total Nasal Symptom Score * Hour |
| AMG 157+Cat Immunotherapy Placebo | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 52 | 0.24 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Baseline | 1.25 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 26 | 0.90 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 52 | 0.73 Total Nasal Symptom Score * Hour |
| Placebo-Placebo | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Week 104 | 0.76 Total Nasal Symptom Score * Hour |