Apraglutide for Graft-versus-Host Disease

Recruiting at 19 trial locations

Overseen By Eremeeva

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: VectivBio AG

Must be taking: SS, RUX

Must not be taking: Methotrexate, Mycophenolate, others

Disqualifiers: Organ failures, GI tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

31 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Holger Adelmann

Principal Investigator

VectivBio AG

Eligibility Criteria

This trial is for individuals aged 12 and above, weighing at least 40 kg, who have steroid refractory gastrointestinal acute graft versus host disease after a stem cell transplant. Participants must use effective contraception if of childbearing potential and can't be on certain other GVHD therapies or have significant organ failures.

Inclusion Criteria

I am 12 years or older and weigh at least 40 kg.

My lower GI acute graft-versus-host disease hasn't improved with steroids.

I am being treated with SS and RUX, starting them at the same time or RUX up to 72 hours before apraglutide.

Exclusion Criteria

I have GI issues after a treatment to prevent cancer return.

I do not have an active, uncontrolled infection or tuberculosis.

I am not taking any Janus kinase inhibitors except for RUX currently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive apraglutide SC injections once weekly, with doses adjusted based on body weight

26 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

104 weeks

Long-term monitoring

Participants are monitored for graft failure, malignancy relapse, and other outcomes

2 years

Treatment Details

Interventions

• Apraglutide

Trial Overview The trial tests the safety and effectiveness of Apraglutide in treating lower GI-aGVHD that hasn’t responded to steroids. Patients will also receive standard treatment with SS plus RUX starting up to five days before or within 72 hours of beginning Apraglutide.

Participant Groups

Group I: Apraglutide Standard Dose Experimental Treatment 1 Intervention

Apraglutide SC injections, once weekly, for subjects with body weight between 40.0 kg to 49.9 kg.

Group II: Apraglutide Low Dose Experimental Treatment 1 Intervention

Apraglutide SC injections, once weekly, for subjects with body weight of more than 50.0 kg.

Group III: Apraglutide High Dose Experimental Treatment 1 Intervention

Apraglutide SC injections, once weekly, for subjects with body weight of more than 50.0 kg.

Who Is Running the Clinical Trial?

VectivBio AG

Lead Sponsor

Trials

11

Recruited

490+