IBM
STUDY COMPLETE
A Phase 1 Study to Evaluate ABC008 (now referred to as ulviprubart) in Adult Patients with Inclusion Body Myositis
Abcuro has evaluated ulviprubart (ABC008) in a Phase 1 study in patients with inclusion body myositis, or IBM, at several clinics in Australia. The purpose of the study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ulviprubart administered as a single dose, followed by multiple doses given every 8 weeks for 48 weeks. In addition, a small group of IBM patients had PET/CT scans of the muscles with an exploratory imaging agent, [89Zr]Zr-Df-crefmirlimab, to understand the effect ulviprubart may have on diseased muscle.
A Phase 2/3 Study to Determine the Efficacy and Safety of ABC008 in Subjects with Inclusion Body Myositis
A Phase 2/3 blinded, randomized, placebo-controlled study evaluating ulviprubart (ABC008) in inclusion body myositis, or IBM patients at several clinics globally. The purpose of this study is to evaluate the safety, tolerability and effect as measured by IBMFRS, the IBM functional rating scale, of one of two doses of ulviprubart compared to a placebo given once every 8 weeks by subcutaneous (SC) injection for approximately 76 weeks. Initially, approximately 30 patients will be enrolled to evaluate the safety and tolerability of ulviprubart at one of the two doses compared to placebo for 3 doses over 20 weeks. Once Part A is completed, Part B may begin and approximately 201 additional patients will be enrolled and dosed with the one of two doses of ulviprubart or placebo every 8 weeks subcutaneously for 76 weeks.
Contact: IBM-201_clinicaltrial@abcuro.com
A Phase 3 Long Term Extension (LTE) Study to Determine the Long-Term Safety and Efficacy of Ulviprubart (ABC008) in Subjects with Inclusion Body Myositis
ABC008-IBM-202 is an open-label Long Term Extension (LTE) study being conducted for patients with Inclusion Body Myositis, or IBM who have completed either study ABC008-IBM-101 or study ABC008-IBM-201. Long-term safety and efficacy of ulviprubart (ABC008) given once every 8 weeks by subcutaneous injection (SC) will be evaluated in these subjects.
Contact: IBM-202_clinicaltrial@abcuro.com
T-LGLL
A Phase 1/2 Study of ABC008 in Subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
A Phase 1/2 open-label study of increasing doses of ulviprubart (ABC008) is being conducted at several clinics in subjects with T-cell large granular lymphocytic leukemia, or T-LGLL. The purpose of the study is to understand the safety, tolerability, pharmacokinetics and pharmacodynamic effect as measured by changes in hemoglobin, neutrophils, and platelets in subjects with T-LGLL. Subjects will receive ulviprubart every 8 weeks subcutaneously for approximately 48 weeks.
Contact: LGL-101_ClinicalTrial@abcuro.com
Expanded Access Policy
We understand that there may be circumstances under which patients or care partners may request treatment with our investigational therapies before they have been approved by regulatory agencies. This is sometimes called “expanded access,” “compassionate use,” “early access,” or a “named patient program.” We use the term “expanded access” to capture all of these.
Abcuro currently does not offer expanded access to our investigational therapies. Should changes be made to our expanded access policy, we will update this website.
Abcuro may revise this policy at any time as provided by the 21st Century Cures Act.
