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Experimental drug targets gut damage in transplant patients

NCT ID NCT05415410

Disease control Sponsor: VectivBio AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested apraglutide, a drug that helps repair the gut lining, in 31 people with severe gastrointestinal graft-versus-host disease (GVHD) after a stem cell transplant. Participants had GVHD that did not respond to steroids. The study aimed to see if apraglutide is safe and can improve gut symptoms. The trial was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apraglutide
What this could lead to
If it works, this could point toward a new treatment option for severe gut complications after stem cell transplant that don't respond to steroids.
What could go wrong
This was a small, early-phase trial that was terminated early, so results are limited. The drug may not improve outcomes and could cause side effects like injection reactions or gallbladder issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

31 people

The number who actually took part.

Started

May 2022

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 system failures (respiratory renal hepatic and cardiac) * Presence of relapsed primary malignancy or treatment for relapse after alloHSCT * Presence or history of GI tumors (including the hepatobiliary system and pancreas) within the last five years before randomization * Presence of colonic polyps not removed * Active clinically uncontrolled infection or active tuberculosis * Known chronic GVHD * Known active GI inflammation not related to GI-aGVHD * Major abdominal surgery in the last 6-months prior to randomization or history of clinically significant intestinal adhesions * Abnormal liver function tests

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GVHD

Contacts and locations

Locations

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Instituto Portugues de Oncologia do Porto Francisco Gentil

    Porto, 4200-072, Portugal

  • Martin Luther Universität Halle-Wittenberg

    Halle, 06120, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • South Austin Medical Center

    Austin, Texas, 78704, United States

  • Stanford Cancer Center

    Stanford, California, 94305, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225, Germany

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20249, Germany

  • Universitätsklinikum Köln (AoeR)

    Cologne, 50937, Germany

  • Universitätsmedizin der Johannes Gutenberg - Universität Mainz

    Mainz, 55131, Germany

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