Proof-of-concept Trial of Apraglutide in GVHD
12 Years and older, Male and Female
TA799-101 (primary)
NCI-2022-05062
Summary
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with
steroid refractory gastrointestinal acute graft versus host disease (aGVHD).
Objectives
This is an international, multicenter, randomized proof-of-concept trial to evaluate safety,
tolerability, efficacy, durability of response, and clinical outcomes of apraglutide
administration to subjects with steroid-refractory (SR) aGVHD of the lower GI tract being
treated with systemic steroids (SS) and ruxolitinib (RUX).
Eligibility
- 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
Treatment Sites in Georgia
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