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Abstract
CATNIP is a clinical research trial, which will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP antibody being co-developed by Amgen and Medimmune) can lead to lasting tolerance to cat allergen.
Current treatment for cat allergy includes taking over the counter or prescription medications or getting allergy shots for 3-5 years. There is no cure for cat allergy. While allergy shots reduce the symptoms, they do not eliminate the allergy.
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 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 eight sites in the US and enroll 120 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. Treatment will be given for about one year, followed by one year off therapy. The objective of the study is to determine whether one year of immunotherapy combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.
About This Study
CATNIP is a clinical research trial, which will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP antibody being co-developed by Amgen and Medimmune) can lead to lasting tolerance to cat allergen.
Current treatment for cat allergy includes taking over the counter or prescription medications or getting allergy shots for 3-5 years. There is no cure for cat allergy. While allergy shots reduce the symptoms, they do not eliminate the allergy.
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 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 eight sites in the US and enroll 120 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. Treatment will be given for about one year, followed by one year off therapy. The objective of the study is to determine whether one year of immunotherapy combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.