Ulviprubart for Inclusion Body Myositis

Recruiting at 14 trial locations

Overseen By Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Abcuro, Inc.

Disqualifiers: Unresolved AE, Pregnancy, Other studies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 156 weeks

270 Participants Needed

Trial Summary

What is the purpose of this trial?

ABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and: * Have completed the Part 2 (Multiple Ascending Dose \[MAD\]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR * Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions restrictions on the use of prohibited medications during the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.

How does the drug Ulviprubart (ABC008) differ from other treatments for inclusion body myositis?

Ulviprubart (ABC008) is unique because it targets CD8+ T cells, which are involved in the muscle inflammation seen in inclusion body myositis, whereas other treatments like corticosteroids and immunosuppressants have limited efficacy. This approach is novel as there are currently no effective drug treatments for this condition. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for people with Inclusion Body Myositis who finished a prior ulviprubart study (ABC008-IBM-101 or ABC008-IBM-201). Participants must understand the study, agree to follow its rules including site visits and self-injections, use effective contraception if applicable, and have shown good compliance in previous studies.

Inclusion Criteria

I am a man and will not donate sperm during the study and for 180 days after it ends.

I can read and understand the consent form and have signed it.

I completed a specific part of either Study ABC008-IBM-101 or Study ABC008-IBM-201.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Within visit window defined in Appendix 1 of the protocol

1 visit (in-person)

Baseline

Baseline assessments and initiation of long-term extension treatment

Day 1

1 visit (in-person)

Treatment

Participants receive ulviprubart 2.0 mg/kg via subcutaneous injection every eight weeks

156 weeks

Visits every 8 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ulviprubart (ABC008)

Trial Overview The trial tests long-term safety and effectiveness of ulviprubart (ABC008) in those with IBM. It's an open-label, multicenter study where all participants receive the drug after completing earlier phases of ulviprubart research.

Participant Groups

Group I: Ulviprubart (ABC008) 2.0 mg/kg SC Experimental Treatment 1 Intervention

All eligible subjects, regardless of treatment assignment or dose level in their initial study, will be administered ulviprubart at a dose of 2.0 mg/kg via subcutaneous (SC) injection Q8W.

Who Is Running the Clinical Trial?

Abcuro, Inc.

Lead Sponsor

Trials

4

Recruited

540+

Findings from Research

In a large study involving 251 participants with inclusion body myositis, bimagrumab demonstrated a good safety profile, with no significant adverse cardiac effects and a similar rate of adverse events compared to placebo.

However, bimagrumab did not show any improvement in the primary outcome measure, the 6-minute walking distance, indicating that while it is safe, it may not be effective in enhancing mobility in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial. Hanna, MG., Badrising, UA., Benveniste, O., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

Treatment of inclusion body myositis with cyclosporin-A or tacrolimus: successful long-term management in patients with earlier active disease and concomitant autoimmune features. [2017]

3. Argentina pubmed.ncbi.nlm.nih.gov

[Inclusion body myositis. Report of 4 cases]. [2006]

4. France pubmed.ncbi.nlm.nih.gov

Isokinetic strength testing for evaluating the efficacy of intravenous immune globulin therapy for inclusion body myositis. [2004]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Emerging therapeutic options for sporadic inclusion body myositis. [2020]