Ulviprubart for Inclusion Body Myositis

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Abcuro, Inc.

No Placebo Group

Prior Safety Data

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.

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.

+4 more

Participant Groups

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.

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.