Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)

Inclusion Criteria: * Able to give informed consent and agree to follow the details of participation as outlined in the protocol * Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg. Only subjects aged 18 years and above will be included in Germany. * Clinically confirmed steroid refractory lower GI-aGVHD (MAGIC stage 1-4) prior to randomization * Have undergone alloSCT from any donor source, any conditioning regimen * Treated with SS plus RUX (RUX starts concomitantly to apraglutide or a maximum of 72 hours before apraglutide initiation) * Women of childbearing potential (WOCBP): highly effective method of contraception and refrain from donating eggs during the trial and for 4 weeks after the End of Trial (EOT) visit * Male subjects with partner WOCBP: contraception and abstention from sperm donation during the trial and for 2 weeks after the EOT visit Exclusion Criteria: * Treatment with any systemic GVHD therapy other than SS and RUX including methotrexate and mycophenolate mofetil at the time of randomization / Day 0 * Concomitant treatment with Janus kinase inhibitor other than RUX at the time of randomization * Failed alloSCT due to relapse of underlying malignant disease * Presence of SR GI-aGVHD occurring after donor lymphocyte infusion for pre-emptive treatment of malignancy recurrence * Any use of enteral glutamine or GLP analogs or known ADA, within 6 months prior to randomization / Day 0 * Significant organ sy…