Depression

Anxiety

Nepeta menthoides Boiss & Bohse freeze dried extract

Sertraline

Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Efficacy of Nepeta Menthoides Boiss & Bohse Freeze Dried Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Sepideh Kolouri

Shiraz University of Medical Sciences

AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.

Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.

AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.

Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.

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

AMG 157+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

AMG 157 Placebo+Cat Immunotherapy

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

AMG 157+Cat Immunotherapy 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

Placebo-Placebo

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

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.

Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)

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.

Skin Prick Test Endpoint Titration

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 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 Late Phase Response (LPR) is the response measured at 6 hours after application.

Skin Late Phase Response (LPR) to Intradermal Testing

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.

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. The trapezoidal rule was used to calculate the TNSS AUC. The Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour.

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 Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours.

Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)

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) 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 Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC.

Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC

Overall Study

Director, Clinical Research Operations Program

AMG 157 administered every four weeks and Cat immunotherapy administered weekly

Placebo for AMG 157 administered every four weeks and Cat immunotherapy administered weekly

AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly

Placebo for AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly

Cat Allergy

Cat Hypersensitivity

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.

AMG 157

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 for allergen-specific immunotherapy administered subcutaneously

Cat Immunotherapy Placebo

Placebo for AMG 157 administered intravenously

AMG 157 Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

Division of Allergy, Immunology, and Transplantation (DAIT)

World Allergy Organization (WAO) Subcutaneous Immunotherapy Systemic Reaction Grading System

University of California, Los Angeles

National Jewish Health

Northwestern University

University of Chicago

Johns Hopkins Asthma & Allergy Center

University of North Carolina, Chapel Hill

Vital Prospects Clinical Research Institute, P.C.

ASTHMA Inc. Clinical Research Center

University Wisconsin, Madison

Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy

Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy (ITN057AD)

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.

nepeta assurgens/hypersensitivity

Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy

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