Active — Not RecruitingPhase 2/3

Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis

United States270 participantsStarted 2024-10-21

Plain-language summary

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.

Who can participate

Age range40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures. 2\. Has participated in and completed either Study ABC008-IBM-101 or Study ABC008-IBM-201; completion of the prior study will be defined as completion of the Part 2 (MAD) EOT Visit in Study ABC008-IBM-101 (subjects may have continued into Part 3 \[MAD Extension\]) or completion of the Week 80 Follow-up Visit in Study ABC008-IBM-201. 3\. Demonstrated adequate compliance, in the opinion of the Investigator, with the study procedures during Study ABC008-IBM-101 or Study ABC008-IBM-201. 4\. Willing and able to comply with the requirements of the protocol, including traveling to the site for study-related assessments and SC injections of ulviprubart. 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. 6\. WOCBP (based on sex assignation at birth) must have a negative urine pregnancy test at the Baseline (Day 1) Visit. 7\. Male subjects (based on sex assignation at birth) must refrain from sperm donation for the duration of the study through 180 days after EOT/ETV. Exclusion Criteria: * 1\. Has an unresolved clinically significant AE or a clinically significant finding on a clinical laboratory test, ECG, or p…

What they're measuring

Primary Endpoint

Timeframe: From Baseline (Day 1) through study completion, an average of 156 weeks.]

Trial details

NCT IDNCT06450886

SponsorAbcuro, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01