A Phase 2a, randomised, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of subcutaneous amlitelimab in adult patients with nonresponsive celiac disease as an adjunct to a gluten-free diet

Research summary

There are Four treatment groups using a 1:1:1:1 ratio, who will receive a study treatment for 24 weeks. For intervention group amlitelimab + GF, they will have amlitelimab 500mg loading dose followed by a 250mg dose once every four weeks + gluten free products for the full 24 weeks. Intervention group placebo + Gluten free, will have matching placebo and gluten free products for the full 24 weeks. The amlitelimab + SIGE (simulated inadvertent gluten exposure) group, will have amlitelimab 500mg loading dose followed by a 250mg dose once every four weeks (24 weeks) + gluten free products for the first 12 weeks + SIGE product for a further 12 weeks. The Placebo + SIGE group, will have the matching placebo (24 weeks) + Gluten free product for the first 12 weeks + SIGE product for a further 12 weeks.

Principal Investigator

Michael Fitzpatrick

Contact us

Email: tglu.research@ouh.nhs.uk

IRAS number

1009840