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