Clinical Trials

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 physical examination during Study ABC008-IBM-101 or Study ABC008 IBM-201 that, in the Investigator's opinion, would limit the subject's ability to participate in or comply with this study.

2. Participation in another investigational drug study (other than Study ABC008-IBM-101 or Study ABC008-IBM-201) within 30 days prior to the Baseline (Day 1) Visit or five times the half-life of the investigational drug, whichever is longer.

3. Is not willing or able to comply with the restrictions regarding the use of prohibited medications throughout the study.

4. Women who are pregnant, lactating, or who plan to become pregnant or initiate lactation during the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/14/2024. Questions regarding updates should be directed to the study team contact.