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| ID | Type | Description | Link |
|---|---|---|---|
| CATNIP | Other Identifier | Immune Tolerance Network |
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| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 157+Cat Immunotherapy | Experimental | AMG 157 will be administered every four weeks. Cat immunotherapy will be administered weekly. |
|
| AMG 157 Placebo+Cat Immunotherapy | Active Comparator | Placebo for AMG 157 of similar appearance will be administered every four weeks. Cat immunotherapy will be administered weekly. |
|
| AMG 157+Cat Immunotherapy Placebo | Experimental | AMG 157 will be administered every four weeks. Placebo for Cat immunotherapy will be administered weekly. |
|
| Placebo-Placebo | Placebo Comparator | Placebo for AMG 157 will be administered every four weeks. Placebo for cat immunotherapy will be administered weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 157 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 1 hour of the NAC at Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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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,
>/=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:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Corren, MD | University of California, Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90025 | United States | ||
| National Jewish Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36223848 | Derived | Corren J, Larson D, Altman MC, Segnitz RM, Avila PC, Greenberger PA, Baroody F, Moss MH, Nelson H, Burbank AJ, Hernandez ML, Peden D, Saini S, Tilles S, Hussain I, Whitehouse D, Qin T, Villarreal M, Sever M, Wheatley LM, Nepom GT, Sanda S; Immune Tolerance Network ITN057AD CATNIP Study Team. Effects of combination treatment with tezepelumab and allergen immunotherapy on nasal responses to allergen: A randomized controlled trial. J Allergy Clin Immunol. 2023 Jan;151(1):192-201. doi: 10.1016/j.jaci.2022.08.029. Epub 2022 Oct 9. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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The plan is to share data in upon completion of the study in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2017 | Mar 10, 2020 |
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|
| Cat Immunotherapy | Biological | A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection |
|
|
| Cat Immunotherapy Placebo | Biological | Placebo for allergen-specific immunotherapy administered subcutaneously |
|
|
| AMG 157 Placebo | Biological | Placebo for AMG 157 administered intravenously |
|
|
| 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. |
| 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104 |
| 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. | 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104 |
| 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. | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 |
| 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. | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 |
| 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. | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104 |
| 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. | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104 |
| 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. | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104 |
| Denver |
| Colorado |
| 80206 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins Asthma & Allergy Center | Baltimore | Maryland | 21231 | United States |
| University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| ASTHMA Inc. Clinical Research Center | Seattle | Washington | 98115 | United States |
| University Wisconsin, Madison | Madison | Wisconsin | 53792 | United States |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Immune Tolerance Network (ITN) Website | View source |
| World Allergy Organization (WAO) Subcutaneous Immunotherapy Systemic Reaction Grading System | View source |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to-treat | Posted | Least Squares Mean | 95% Confidence Interval | Total Nasal Symptom Score * Hour | 0 to 1 hour of the NAC at Week 104 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | A cross-sectional analysis of the observed measures within the intent-to-treat population was used in the reporting of secondary endpoints. | Posted | Mean | 95% Confidence Interval | mm | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Posted | Mean | 95% Confidence Interval | mm | 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Posted | Mean | 95% Confidence Interval | mm | 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Posted | Mean | 95% Confidence Interval | Peak Total Nasal Symptom Score | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Posted | Mean | 95% Confidence Interval | Total Nasal Symptom Score * Hour | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Posted | Mean | 95% Confidence Interval | Total Nasal Symptom Score * Hour | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Posted | Mean | 95% Confidence Interval | L/min * Hour | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Posted | Mean | 95% Confidence Interval | L/min * Hour | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104 |
|
2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population.
1. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMG 157+Cat Immunotherapy | AMG 157 administered every four weeks and Cat immunotherapy administered weekly | 0 | 32 | 1 | 32 | 25 | 32 |
| EG001 | AMG 157 Placebo+Cat Immunotherapy | Placebo for AMG 157 administered every four weeks and Cat immunotherapy administered weekly | 0 | 31 | 3 | 31 | 18 | 31 |
| EG002 | AMG 157+Cat Immunotherapy Placebo | AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly | 0 | 29 | 0 | 29 | 18 | 29 |
| EG003 | Placebo-Placebo | Placebo for AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly | 0 | 28 | 0 | 28 | 19 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-Cause Mortality | General disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MEDDRA V17.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA V17.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MEDDRA V17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Injection site hypersensitivity | Immune system disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MEDDRA V17.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MEDDRA V17.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MEDDRA V17.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MEDDRA V17.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA V17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA V17.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MEDDRA V17.0 | Systematic Assessment |
|
None listed
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2019 | Mar 10, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000622721 | tezepelumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
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