Ulviprubart for Inclusion Body Myositis

Phase 2 & 3

Recruiting

Research Sponsored by Abcuro, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6. WOCBP (based on sex assignation at birth) must have a negative urine pregnancy test at the Baseline (Day 1) Visit.

5. Women of childbearing potential (WOCBP) and male subjects with female partners who are WOCBP (based on sex assignation at birth) must agree to use highly effective (< 1% failure rate) contraception for the duration of the study through 180 days after EOT/ETV.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) through study completion, an average of 156 weeks.]

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the long-term use of a medication called ulviprubart in people with Inclusion Body Myositis (IBM). Participants must have completed specific parts of previous studies to be eligible

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed here but typically include reactions at injection sites, potential immune responses due to the drug's nature as a treatment for inflammatory conditions like IBM, fatigue, muscle pain or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman of childbearing potential and my pregnancy test is negative.

Select...

I agree to use highly effective birth control during and up to 6 months after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) through study completion, an average of 156 weeks.]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) through study completion, an average of 156 weeks.]

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) through study completion, an average of 156 weeks.] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Endpoint

Secondary study objectives

Adverse Events of Special Interest (AESI)

Change from baseline in standard laboratory parameters (Chemistry)

Change from baseline in standard laboratory parameters (Coagulation)

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ulviprubart (ABC008) 2.0 mg/kg SCExperimental Treatment1 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.

0 / 2Eligibility criteria met