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Long-term Extension Study of Ulviprubart (ABC008) in Subjects with Inclusion Body Myositis
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.
Study details:
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. Subjects will enter this study following their initial study such that dosing continues every eight weeks (Q8W) between the last dose in the initial study and the first dose in this long-term extension (LTE) Study IBM-202. Study subjects will continue to receive any ongoing concomitant medications from the initial study.
Subjects will be required to sign an informed consent form before undertaking any study-specific procedures or assessments. Screening is intended to be done at the final visit of the initial study, which will coincide with the Baseline (Day 1) Visit for this study; if this is not possible, the Baseline (Day 1) Visit for this study, including screening, may be conducted at a separate visit (provided it occurs within the visit window defined in Appendix 1 of the protocol). Subsequent study visits will occur every eight weeks until EOT at Week 156, or withdrawal from the study.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 40 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-10-21
Primary completion: 2029-01-01
Study completion finish: 2029-04-01
Study type
TREATMENT
Phase
PHASE2
PHASE3
Trial ID
NCT06450886
Intervention or treatment
DRUG: Ulviprubart (ABC008)
Conditions
- • Inclusion Body Myositis (IBM)
Find a site
Closest Location:
Royal Brisbane and Women's Hospital
Research sites nearby
Select from list below to view details:
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Perron Institute for Neurological and Translational Science
Nedlands, Washington, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Ulviprubart (ABC008) 2.0 mg/kg SC
| DRUG: Ulviprubart (ABC008)
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Primary Endpoint | The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs). Safety as assessed by the incidence, type and severity of Treatment Emergent Adverse Events (TEAEs) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Treatment Emergent Serious Adverse Events (TEASAEs) | Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration. | Incidence of TEAEs leading to study medication or study discontinuation | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Adverse Events of Special Interest (AESI) | Incidence of Adverse events of special interest (AESIs) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Change from baseline standard laboratory parameters (Hematology) | Incidence of clinically significant changes in standard laboratory parameters (Hematology) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Change from baseline in standard laboratory parameters (Chemistry) | Incidence of clinically significant changes from baseline in standard laboratory parameters (Chemistry) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Change from baseline in standard laboratory parameters (Coagulation) | Incidence of clinically significant changes from baseline standard laboratory parameters (Coagulation) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Inclusion Body Myositis Functional Rating Scale (IBMFRS) | Mean change from Baseline (Day 1) in IBMFRS over the duration of the study | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Manual Muscle Test 12 (MMT 12) | Mean change from Baseline (Day 1) in MMT 12 over the duration of the study | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Change from baseline in standard vital signs (respiratory rate) | Incidence of clinically significant changes in vital signs (respiratory rate) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Change from baseline in standard vital signs blood pressure | Incidence of clinically significant changes in standard vital signs blood pressure (Systolic and diastolic) blood pressure) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Change from baseline in standard vital signs (temperature) | Incidence of clinically significant changes in standard vital signs (temperature) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Change from baseline in standard vital signs (pulse rate) | Incidence of clinically significant changes in standard vital signs (pulse rate) | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Counts of absolute and KLRG1+ lymphocytes by flow cytometry. | Blood samples will be collected for immunophenotyping. Counts of absolute and KLRG1+ lymphocytes and other lymphocyte subsets will be performed by flow cytometry. | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Presence and titer of antidrug antibodies (ADA) | The incidence and titers of ADAs to ulviprubart will be evaluated in blood samples | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
| Serum concentration of ulviprubart | Individual and mean serum concentration time profiles will be presented graphically using nominal time points. | From Baseline (Day 1) through study completion, an average of 156 weeks.] |
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