At a glance
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Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy (ITN057AD)
In Brief
A Phase 2 clinical trial evaluating AMG 157, Cat Immunotherapy, and 2 other interventions for Cat Allergy and Cat Hypersensitivity. Completed, enrolled 121 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
Placebo for allergen-specific immunotherapy administered subcutaneously
Placebo for AMG 157 administered intravenously