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A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis.
Study of ABC008 in Patients with Inclusion Body Myositis (IBM)
| Sponsor: | Abcuro |
| Enrolling: | Male and Female Patients |
| Study Length: | 2 Years |
| Clinic Visits: | 18 |
| IRB Number: | AAAU5361 |
| U.S. Govt. ID: | NCT05721573 |
| Contact: | Raisy Fayerman, CRC: 212-305-6035 / rf2632@cumc.columbia.edu |
Additional Study Information:
This is A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis. This is a randomized, double-blind, placebo-controlled, multicenter study. If you are eligible, you will be randomized. Randomized means the study treatment you take will be chosen for you by chance. Double-blind means that neither you nor the Study Doctor will know what treatment you will receive. Inclusion criteria must be met for a subject to be eligible for inclusion in the study: Adult males and females age 40 years at the time of the first dose of study medication, Weight 88 and 330 lbs, Willing and able to comply with the requirements of the protocol, including traveling to the site for study-related assessments and SC injections, and using electronically administered diaries and questionnaires.
Do You Qualify?
| Are you an adult males and females age 40 years? | Yes | No |
| Do you weigh between 88 and 330 lbs.? | Yes | No |
| Are you able to arise from a chair (with armrests), with use of their arms but without support from another person or device? | Yes | No |
| Are you able to walk three meters, turn around, walk back to the chair, and sit down, with or without assistive device? | Yes | No |
| Are you willing and able to comply with the requirements of the protocol? | Yes | No |