Proof-of-concept Trial of Apraglutide in GVHD

• Status: Recruiting
• Trial end date: 2025-08-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VectivBio AG

Criteria

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

• Histologically confirmed lower GI-aGVHD at screening (MAGIC stage 1-4) with clinically confirmed SR

• Have undergone alloSCT from any donor source

• Treated with SS plus RUX at recommended dose twice daily for 0-5 days prior to enrolment/randomization)

• Clinically confirmed SR GI-aGVHD

• Women of childbearing potential (WOCBP): highly effective method of contraception 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: methotrexate & mycophenolate mofetil at the time of enrolment/randomization

• Concomitant treatment with Janus kinase inhibitor other than RUX

• Systemic corticosteroid therapy for indications other than aGVHD within 7 days prior to screening

• Failed previous alloSCT

• Any use of enteral glutamine or GLP analogs Significant organ system failures (respiratory renal hepatic and cardiac)

• Relapsed primary malignancy GI tumors or colonic polyps

• Active clinically uncontrolled infection

• Known chronic GVHD

• Known active GI inflammation not related to GI-aGVHD

• Major abdominal surgery in the last 6-months prior to screening and history of clinically significant intestinal adhesions

• Abnormal liver function tests