31 Participants Needed

Apraglutide for Graft-versus-Host Disease

Recruiting at 19 trial locations
E
Overseen ByEremeeva
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: VectivBio AG
Must be taking: SS, RUX
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

HA

Holger Adelmann

Principal Investigator

VectivBio AG

Are You a Good Fit for This Trial?

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.
See 4 more

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.
See 11 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Apraglutide Standard DoseExperimental Treatment1 Intervention
Group II: Apraglutide Low DoseExperimental Treatment1 Intervention
Group III: Apraglutide High DoseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VectivBio AG

Lead Sponsor

Trials
11
Recruited
490+
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