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Apraglutide

Clinical trials of Apraglutide are studying its safety and tolerability in people with short bowel syndrome and in patients with steroid-refractory acute graft versus host disease. These studies also look at how well it works in these groups and monitor important health measures during treatment.

Table of Contents

Trial overview

The source data include two interventional studies of Apraglutide, which means participants received the study treatment so researchers could observe its effects.[1][2]

One trial studied people with short bowel syndrome and intestinal failure, and the other studied patients with steroid-refractory acute graft versus host disease.[1][2]

The trials are in different phases: one is Phase 3 and the other is Phase 2.[1][2]

Short bowel syndrome study

NCT05018286 is a Phase 3 study titled “Long-term safety of apraglutide in short bowel syndrome.”[1]

This study is authorised and includes 152 participants.[1]

The brief summary says the study was designed to assess long-term safety and tolerability in subjects with SBS-IF, which stands for short bowel syndrome with intestinal failure.[1]

The intervention listed is Apraglutide given by subcutaneous use, meaning it is given under the skin.[1]

Acute graft versus host disease study

NCT05415410 is a Phase 2 study titled “Efficacy and Safety of apraglutide in steroid refractory gastrointestinal acute graft versus host disease.”[2]

This study is completed and enrolled 29 participants.[2]

The study focused on SR lower GI-aGVHD Grade II to IV, which means steroid-refractory lower gastrointestinal acute graft versus host disease from moderate to severe stages.[2]

The brief summary says the study looked at safety and tolerability in patients treated with SS and RUX, as described in the source data.[2]

The intervention was Apraglutide given by subcutaneous injection at 10 mg.[2]

What researchers measure

Both trials mainly tracked adverse events, which are unwanted medical problems that happen during a study, whether or not they are caused by the treatment.[1][2]

The short bowel syndrome trial also measured clinically relevant adverse events of special interest, including injection site reactions, gastrointestinal obstructions, gallbladder, biliary and pancreatic disease, fluid overload, colorectal polyps, and malignancies.[1]

The acute graft versus host disease trial measured similar safety topics and also looked for systemic hypersensitivity, which means a body-wide allergic-type reaction, and anti-drug antibodies, which are immune proteins that can react to a treatment.[2]

Both studies checked laboratory tests such as clinical chemistry, hematology, hemostasis, and urinalysis, as well as vital signs like blood pressure and heart rate.[1][2]

The trials also monitored electrocardiogram, or ECG, findings, which show the heart’s rhythm and electrical intervals.[1][2]

Who the trials are for

The short bowel syndrome trial was aimed at subjects with SBS-IF, meaning people with short bowel syndrome and intestinal failure.[1]

The acute graft versus host disease trial was aimed at patients with steroid-refractory lower gastrointestinal acute graft versus host disease, Grade II to IV, according to the source data.[2]

These are very different patient groups, so the studies cannot be mixed together when thinking about who may take part.[1][2]

What the trial phases mean

Phase 2 studies usually look for early signs of benefit and continue safety checks in a smaller group of patients.[2]

Phase 3 studies are later and usually include more people to better understand safety and treatment effects.[1]

In the source data, the Phase 3 study is larger than the Phase 2 study, with 152 participants compared with 29 participants.[1][2]

Together, these trials show that Apraglutide is being studied in both an earlier and a later research setting, across two serious conditions.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05018286Phase 3Short bowel syndromeAuthorised152
NCT05415410Phase 2Acute graft versus host diseaseCompleted29

FAQ

  • What conditions are being studied in Apraglutide trials? The trials in the source data study short bowel syndrome and acute graft versus host disease. These are serious conditions with very different patient needs.
  • Who may take part in Apraglutide studies? One trial includes people with short bowel syndrome and intestinal failure. Another includes patients with steroid-refractory lower gastrointestinal acute graft versus host disease of Grade II to IV.
  • What phases are the Apraglutide trials? The short bowel syndrome study is Phase 3. The acute graft versus host disease study is Phase 2.
  • What are the trials mainly trying to find out? They are mainly checking safety and tolerability. The studies also measure clinical changes, treatment-related side effects of special interest, and other health tests.
  • Are both Apraglutide trials finished? No. One trial is completed, and the other is authorised. This means the studies are at different stages.

Ongoing Clinical Trials on Apraglutide

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

    Not recruiting

    1 1
    Investigated drugs:
    Germany

  • Long-term safety study of apraglutide (weekly injections) in patients with Short Bowel Syndrome

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark France Germany Hungary +5

Glossary

  • Short bowel syndrome: A condition where the small intestine is too short to absorb enough nutrients and fluids.
  • Intestinal failure: When the bowel cannot absorb enough nutrition and fluids to keep the body healthy.
  • Acute graft versus host disease: A serious reaction that can happen after a transplant, when donor cells attack the body.
  • Steroid refractory: Not improving enough with steroid treatment.
  • Grade II to IV: A severity scale showing a moderate to very severe form of disease.
  • Interventional study: A study where participants receive a treatment so researchers can measure its effects.
  • Phase 2: An earlier trial phase that usually looks at safety and early signs of benefit.
  • Phase 3: A later trial phase that studies safety and effectiveness in a larger group.
  • Adverse events: Unwanted medical problems that happen during a study, whether or not they are caused by the treatment.
  • Primary outcome: The main result researchers plan to measure in a trial.
  • Electrocardiogram (ECG): A test that records the heart’s electrical activity and rhythm.

References