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Study on the Safety and Effectiveness of Apraglutide for Patients with Steroid-Resistant Gastrointestinal Acute Graft Versus Host Disease

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Acute Graft Versus Host Disease (aGVHD), which can occur after a stem cell or bone marrow transplant. The trial is investigating the safety and effectiveness of a treatment called apraglutide, which is a powder that is mixed into a solution and given as an injection under the skin. The study is specifically looking at patients who have aGVHD that affects the gastrointestinal tract and does not respond to standard steroid treatments.

The purpose of the study is to evaluate how well apraglutide works and how safe it is for patients with this type of aGVHD. Participants in the study will receive either apraglutide or a placebo, in addition to their current best available therapy. The study will monitor participants over a period of time to observe any changes in their condition and to check for any side effects. The trial will also assess how the treatment affects the overall health and recovery of the participants.

Throughout the study, participants will have regular check-ups to track their progress and any potential side effects. The trial aims to provide valuable information on whether apraglutide can be a beneficial treatment option for patients with steroid-refractory gastrointestinal aGVHD. The study is expected to continue until 2025, allowing researchers to gather comprehensive data on the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, the patient must have signed informed consent. This is a document that confirms understanding and agreement to participate in the trial.
The patient must be at least 12 years old and weigh a minimum of 40 kg. In some countries, only those aged 18 and above are eligible.
Step 2
Initial assessment
The patient must have undergone a stem cell transplant from a donor and show evidence of myeloid and platelet engraftment. This means the body has started producing blood cells from the transplanted stem cells.
A clinical diagnosis of lower gastrointestinal acute graft versus host disease (GI-aGVHD) is required. This condition involves the immune system attacking the gastrointestinal tract.
Step 3
Treatment initiation
The patient will begin treatment with apraglutide, a medication administered through subcutaneous injection. This involves injecting a solution under the skin.
The treatment is combined with other medications, such as steroids and RUX (ruxolitinib), which may start up to 72 hours before apraglutide.
Step 4
Monitoring and follow-up
Throughout the trial, the patient will be monitored for any adverse events, which are unexpected medical issues that may arise during treatment.
Regular assessments will be conducted to evaluate the response to treatment, including changes in symptoms and overall health.
Step 5
Completion of trial
The trial is expected to continue until August 2025. During this time, the patient will have regular check-ups to assess the effectiveness and safety of the treatment.
After completing the trial, the patient will have a final evaluation to determine the overall impact of the treatment on their condition.

Who can join the trial?

9 criteria

Must sign a consent form before any trial-related activities. If under 18, a signed assent form is also needed.
Must be male or female, aged 12 years or older, and weigh at least 40 kg. In Germany and France, only those 18 and older can participate.
Must have had a type of stem cell transplant called **alloSCT** from any donor source, using bone marrow, peripheral blood stem cells, or cord blood. Different conditioning treatments before the transplant are allowed.
Must have evidence of **myeloid** and **platelet engraftment**, meaning the body is producing certain blood cells. This is confirmed by having a specific number of **neutrophils** (a type of white blood cell) and **platelets** (cells that help with blood clotting). Support with growth factors and transfusions is allowed.
Must have a clinical diagnosis of lower **GI-aGVHD** (a condition affecting the gut) at a specific stage. Tests should be done to rule out other causes of diarrhea, like infections.
Must have **steroid-refractory** lower GI-aGVHD, meaning the condition did not improve with certain steroid treatments. This includes specific criteria about how the condition responded to treatment.
Must be treated with **SS** and **RUX**, with RUX starting at the same time as or up to 72 hours before another trial medication called apraglutide.
Women who can have children must agree to use a highly effective birth control method and not donate eggs during the trial and for 4 weeks after the end of treatment. Certain birth control methods are specified, and in Germany, oral methods must be combined with another method.
Men with a female partner who can have children must agree to use birth control and not donate sperm during the trial and for 2 weeks after the end of treatment. If their partners can have children, they must use a highly effective birth control method during the trial and for 4 weeks after.

Who cannot join the trial?

8 criteria

Patients who do not have **acute graft versus host disease (aGVHD)**. This is a condition that can occur after a bone marrow transplant where the donated cells attack the recipient's body.
Patients who are not experiencing **steroid-refractory (SR) lower gastrointestinal (GI) aGVHD**. This means the condition does not improve with standard steroid treatment and affects the lower part of the digestive system.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not able to follow the study procedures or attend required visits.
Patients who have other medical conditions that might interfere with the study or pose a risk to their health.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial that might interfere with this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Verified
Martin-Luther-Universitaet Halle-Wittenberg
Halle (Saale), Germany
Verified
Medical Center - University Of Freiburg
Freiburg Im Breisgau, Germany

Trial locations

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Investigated drugs

Apraglutide
is being studied for its safety and effectiveness in patients with certain types of gastrointestinal issues related to graft versus host disease. It is being tested to see if it can help improve symptoms when other treatments have not worked.
SS
refers to supportive care measures that are part of the best available therapy for managing symptoms and improving the quality of life for patients with gastrointestinal graft versus host disease.
RUX
is a medication used in the trial to help manage symptoms of graft versus host disease. It is part of the best available therapy and works by targeting specific pathways in the body to reduce inflammation and improve patient outcomes.

Apraglutide

What is already known about the treatment

Apraglutide – Apraglutide is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its safety and effectiveness in treating acute graft versus host disease (aGVHD), particularly in cases that do not respond to steroids. The medication is designed to help manage symptoms in the gastrointestinal tract associated with this condition. At the molecular level, apraglutide works by mimicking a natural hormone that influences gut function, potentially reducing inflammation and promoting healing. It is classified as a glucagon-like peptide-2 (GLP-2) analog, which is a type of medication that targets specific receptors in the body to achieve its effects.

Investigated diseases

Acute Graft Versus Host Disease (aGVHD) – This condition occurs when donor immune cells attack the recipient's body after a stem cell or bone marrow transplant. It primarily affects the skin, liver, and gastrointestinal tract. Symptoms can include skin rashes, jaundice, and diarrhea. The severity of the disease can vary, with some cases being mild and others more severe. The disease progresses as the donor's immune cells continue to attack the recipient's tissues, leading to inflammation and damage. The progression and symptoms can differ based on the organs involved and the intensity of the immune response.