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ULVIPRUBART

Clinical trials are studying ULVIPRUBART in people with inclusion body myositis, a muscle disease that causes weakness. These studies are looking at long-term safety, tolerability, and signs of benefit. They include adults with this condition and use measures such as adverse events and functional scores.

Table of contents

Trial overview

Clinical trials of ULVIPRUBART are being done in people with inclusion body myositis (IBM), which is a muscle disease that can cause weakness and make daily movement harder.[1][2]

The available trial data focus on whether ULVIPRUBART is safe, whether people can tolerate it, and whether it may help with function in IBM.[1][2]

Condition studied

Both trials in the source data study inclusion body myositis only.[1][2]

IBM is the only condition named in the trial records, so the article does not describe other diseases or uses.[1][2]

Trial design and phases

One study is a long-term extension study in Phase 3 and is authorised.[1]

A long-term extension study means people are followed for a longer time after earlier study parts, so researchers can learn more about ongoing safety and tolerability.[1]

The other study is listed as a Phase 4 trial and is completed.[2]

This second study includes different parts: a sentinel cohort, a double-blind safety and efficacy cohort, and a PD recovery cohort.[2]

Double-blind means that neither the participants nor the study team know who gets the active treatment and who gets the placebo during that part of the study.[2]

Who can participate

The trial records say the studies are for subjects with inclusion body myositis.[1][2]

The source data do not give full entry rules such as age limits, lab test rules, or other detailed eligibility criteria, so those details are not shown here.[1][2]

What is being measured

One main safety endpoint is the incidence, type, and severity of treatment-emergent adverse events, often called TEAEs.[1]

TEAEs are new health problems or side effects that appear after treatment starts.[1]

In the Phase 4 study, one primary outcome is the mean change from baseline in the IBM Functional Rating Scale, also called IBMFRS, at Week 76.[2]

Baseline means the starting point before treatment begins, so change from baseline shows whether scores go up or down over time.[2]

Another endpoint in the Phase 4 study is PD recovery, measured by the time from end of treatment or end-of-treatment visit to recovery of KLRG1+ cells.[2]

PD recovery here refers to recovery after the treatment effect on the measured cells, based on the study record.[2]

Key trial details

The long-term extension study, NCT06450886, is in Phase 3, is authorised, and plans to enroll 270 people with IBM.[1]

Its brief summary says the study is meant to assess the long-term safety and tolerability of ulviprubart (ABC008) in subjects with inclusion body myositis.[1]

The second study, NCT05721573, is completed, has an enrollment of 219, and is described as a Phase II/III study in the title but listed as Phase 4 in the trial record.[2]

That study compares placebo to ULVIPRUBART in a double-blind safety and efficacy cohort and also includes a cohort focused on cell recovery after treatment ends.[2]

Its brief summary states that the study aimed to determine efficacy at two subcutaneous dose levels using IBMFRS at Week 76 and to assess safety and tolerability in people with IBM.[2]

Both studies use subcutaneous injection, which means the treatment is given under the skin.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
NCT06450886Phase 3Inclusion body myositisAuthorised270
NCT05721573Phase 4Inclusion body myositisCompleted219

FAQ

  • What condition are ULVIPRUBART trials studying? The trials are studying inclusion body myositis, often called IBM. This is a muscle disease that can cause muscle weakness and trouble with daily activities.
  • Who can take part in these studies? The studies are for subjects with inclusion body myositis. The trial data does not give more detailed entry rules, so exact participation requirements are not shown here.
  • What phases are the ULVIPRUBART trials in? The trial data includes a Phase 3 long-term extension study and another study listed as Phase 4. One study also has parts focused on safety, efficacy, and recovery after treatment.
  • What are the trials trying to find out? The studies are checking long-term safety and tolerability, and they are also looking at whether ULVIPRUBART helps improve function in IBM. One part also studies recovery of KLRG1+ cells after treatment ends.
  • What outcomes are being measured? One main outcome is treatment-emergent adverse events, which means new side effects that appear after treatment starts. Another outcome is change in IBMFRS, a scale that measures function in people with IBM.

Ongoing Clinical Trials on ULVIPRUBART

  • Title: Long-term safety and effectiveness study of Ulviprubart in patients with inclusion body myositis who completed previous treatment

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany

  • Study on the Safety and Effectiveness of ABC008 for Patients with Inclusion Body Myositis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany

Glossary

  • Inclusion body myositis (IBM): A muscle disease that can lead to weakness and problems with movement and daily tasks.
  • Phase 3: A later stage of clinical research that usually studies a treatment in a larger group of people.
  • Phase 4: A study phase that happens after a treatment has already been studied more widely and may focus on safety or other questions.
  • Interventional study: A study where people receive a treatment or placebo so researchers can compare results.
  • Placebo: A test product that does not contain the active treatment, used for comparison in a study.
  • Safety: How well a treatment is tolerated and whether it causes unwanted effects.
  • Tolerability: How easily people can take a treatment without major problems.
  • Treatment-emergent adverse events (TEAEs): New medical problems or side effects that start after treatment begins.
  • IBM Functional Rating Scale (IBMFRS): A score used to measure function in people with inclusion body myositis.
  • KLRG1+ cells: A type of cells measured in one study to see how they recover after treatment ends.
  • End of treatment (EOT): The time when the study treatment is finished.
  • End of treatment visit (ETV): A study visit that happens when treatment ends, used to check health and study results.

References