In short
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.
Key points
- ULVIPRUBART is being studied in clinical trials for inclusion body myositis, a muscle disease that causes weakness. The trial data includes a long-term extension study in Phase 3 and another study listed as Phase 4. Researchers are mainly looking at safety, tolerability, and whether the treatment may help function in people with IBM. One study measures treatment-emergent adverse events, while another measures change in IBMFRS, a function score for IBM. The studies include people with inclusion body myositis and also look at recovery of KLRG1+ cells after treatment ends.
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.
The available trial data focus on whether ULVIPRUBART is safe, whether people can tolerate it, and whether it may help with function in IBM.
Condition studied
Both trials in the source data study inclusion body myositis only.
IBM is the only condition named in the trial records, so the article does not describe other diseases or uses.
Trial design and phases
One study is a long-term extension study in Phase 3 and is authorised.
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.
The other study is listed as a Phase 4 trial and is completed.
This second study includes different parts: a sentinel cohort, a double-blind safety and efficacy cohort, and a PD recovery cohort.
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.
Who can participate
The trial records say the studies are for subjects with inclusion body myositis.
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.
What is being measured
One main safety endpoint is the incidence, type, and severity of treatment-emergent adverse events, often called TEAEs.
TEAEs are new health problems or side effects that appear after treatment starts.
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.
Baseline means the starting point before treatment begins, so change from baseline shows whether scores go up or down over time.
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.
PD recovery here refers to recovery after the treatment effect on the measured cells, based on the study record.
Key trial details
The long-term extension study, NCT06450886, is in Phase 3, is authorised, and plans to enroll 270 people with IBM.
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.
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.
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.
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.
Both studies use subcutaneous injection, which means the treatment is given under the skin.